SAFETY DATA SHEET Tetrapotassium pyrophosphate Table of
Transcription
SAFETY DATA SHEET Tetrapotassium pyrophosphate Table of
SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx Table of Contents 1. Identification of the substance/mixture and of the company/undertaking ......................2 2. Hazards identification...................................................................................................3 3. Composition / information on ingredients .....................................................................4 4. First aid measures .......................................................................................................4 5. Fire fighting measures .................................................................................................5 6. Accidental release measures .......................................................................................5 7. Handling and storage ...................................................................................................5 8. Exposure controls / personal protection .......................................................................6 9. Physical and chemical properties .................................................................................8 10. Stability and reactivity ................................................................................................9 11. Toxicological information .........................................................................................10 12. Ecological information ..............................................................................................10 13. Disposal considerations ...........................................................................................12 14. Transport information ...............................................................................................12 15. Regulatory information .............................................................................................13 16. Other information .....................................................................................................13 Annex: summary of relevant exposure scenarios ...........................................................15 ES1: Manufacture of TKPP ............................................................................................15 ES2: Mixing TKPP into final products.............................................................................19 ES3: Use as raw material and process aid in chemical synthesis ..................................29 ES4: Use of TKPP and products containing TKPP for treatment and finishing of metals ..............................................................................................................35 ES5: Leather and textiles manufacturing and treatment with products containing TKPP ...............................................................................................................45 ES6: Use of TKPP and products containing TKPP for water and wastewater treatment..........................................................................................................51 ES7: Industrial and professional use of washing and cleaning products containing TKPP ...............................................................................................................61 ES8: Application in oil well and other drilling fluid applications, liquefying and conditioning earths, mud, clays ........................................................................72 ES9: Use of TKPP and products and materials containing TKPP in ceramic manufacture and construction and building work ..............................................78 ES10: Professional and consumer use of TKPP and products containing TKPP in fertiliser products..............................................................................................88 ES11: Consumer use of detergents ...............................................................................93 ES12: Consumer use of cosmetics, toothpaste and other products containing TKPP ....95 NOTICE : Important information Please note that this generic exposure scenario is by no means intended to be mandatory, prescriptive or exhaustive. The content of this document is intended for guidance only and whilst the information on uses covered is provided in utmost good faith and has been based on the best information currently available, is to be relied upon at the user’s own risk. Ultimately, it is for each company to assess the appropriateness and Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 1/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx completeness of the information on a case-by case basis and decide what elements they wish to adopt or to add. In particular, the preparation and content of the e-SDS is the legal responsibility of each company for its own products placed on the market, and the user should verify, complete, correct or adapt this generic document appropriately. No representations or warranties are made with regards to its completeness or accuracy, in particular regarding the list of uses that are covered, and no liability will be accepted by [the consortium members] for damages of any nature whatsoever resulting from the use of or reliance on the information. The consortium members acknowledge that any activities carried out under REACH have to be carried out in full compliance with EU competition law, in particular but not limited to Articles 101 and 102 of the Treaty on the Functioning of the European Union (TFEU) as well as any applicable national laws. SECTION 1. Identification of the substance/mixture and of the company/undertaking 1.1 Product identifier: Tetrapotassium pyrophosphate EINECS Number: 230-785-7 CAS Number: 7320-34-5 REACH Registration number: [to be filled in by company] Other identifiers: TKPP 1.2 Relevant identified uses of the substance or mixture and uses advised against: Industrial / professional uses: - Manufacture of TKPP (exposure scenario 1) - Mixing TKPP into final products (exposure scenario 2) - Use as raw material and process aid in chemical synthesis and as a laboratory agent (exposure scenario 3) - Use of TKPP and products containing TKPP for treatment and finishing of metals (exposure scenario 4) - Leather and textiles manufacturing and treatment with products containing TKPP (exposure scenario 5) - Use of TKPP and products containing TKPP for water and wastewater treatment (exposure scenario 6) - Industrial and professional use of washing and cleaning products containing TKPP (exposure scenario 7) - Application in oil well and other drilling fluid applications, liquefying and conditioning earths, mud, clays (exposure scenario 8) - Professional use of TKPP and products and materials containing TKPP in ceramic manufacture and construction and building work (exposure scenario 9) - Professional use of TKPP and products containing TKPP in fertiliser products (exposure scenario 10) Consumer uses: - Use of TKPP and products and materials containing TKPP in ceramic manufacture and construction and building work (exposure scenario 9) - Consumer use of TKPP and products containing TKPP in fertiliser products (exposure scenario 10) - Consumer use of detergents (exposure scenario 11) - Consumer use of cosmetics, toothpaste and other products containing TKPP (exposure scenario 12) - Use in food, animal feeds, medical and pharmaceutical products containing TKPP (listed for supply chain information, exempted from REACH, NO EXPOSURE SCENARIO) Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 2/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx No known uses advised against. 1.3 Details of the supplier of the safety data sheet: [Insert relevant details including contact name, address, phone number, email here] 1.4 Emergency telephone number: [Insert suitable emergency number and hours of operation] SECTION 2. Hazards identification 2.1 Classification of the substance 2.1.1 According to Regulation (EC) No. 1272/2008 (EU CLP): 2.1.2 According to Directive 67/548/EC (DSD): Eye Irritation 2, H319:Causes serious eye irritation Xi; R36 Irritant; Irritating to eyes 2.2 Label elements 2.2.1 According to Regulation (EC) No. 1272/2008 (EU CLP): Name: Tetrapotassium pyrophosphate Index Number: Not applicable CAS Number: 7320-34-5 Signal word: Warning Hazard Statements: H319: Causes serious eye irritation. Precautionary Statements: Prevention: P264: Wash hands thoroughly after handling. P280: Wear protective gloves/protective clothing/eye protection/face protection. Response: P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing P337+P313: If eye irritation persists: Get medical advice/attention. Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 3/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx NOTE: Information in Section 2.2 MUST be consistent with the information provided on the supplier’s labels. 2.3 Other hazards The material is not considered to be PBT or vPvB. SECTION 3. Composition / information on ingredients 3.1 Substance: Name EC Number CAS Number Tetrapotassium pyrophosphate 230-785-7 7320-34-5 Typical concentration >90% [Taken from SIP - specific company to update where necessary] Concentration Range [to be provided by company] Registration Number (if available): [specific to each registrant – insert number here] EC name: tetrapotassium pyrophosphate Identification of hazardous impurities (where applicable): All impurities > 1% are other inorganic phosphates or other related inorganic substances, similar to the Registered substance, and which do not significantly affect its toxicological and ecotoxicological properties All hazardous impurities are < 0.1% NOTE: The above information on impurities is company specific therefore suppliers to update where necessary and in line with the data that is provided in their joint registration dossier Section 1.2. SECTION 4. First aid measures 4.1 Description of first aid measures Inhalation In case of exposure by inhalation, provide fresh air. Ingestion Rinse out mouth and then drink plenty of water (approx. 500 ml). In case of symptoms consult doctor. Skin Contact In case of contact with skin, rinse with plenty of water and soap. Eye Contact IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. 4.2 Most important symptoms and effects, both acute and delayed Tetrapotassium pyrophosphate causes irritation. No delayed effects are noted. 4.3 Indication of any immediate medical attention and special treatment needed No specific information available. Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 4/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx SECTION 5. Fire fighting measures 5.1 Extinguishing media Suitable extinguishing media: Tetrapotassium pyrophosphate is not flammable. Use fire fighting measures that suit the environment; CO2, extinguishing powder or water jet. Fight larger fires with foam. Inappropriate extinguishing media: Not applicable. 5.2 Special hazards arising from the substance or mixture None. 5.3 Advice for fire-fighters In cases where dust particles of tetrapotassium pyrophosphate may be present respiratory ventilation is recommended. Wear appropriate eye protection. See Section 8.2. SECTION 6. Accidental release measures 6.1 Personal precautions, protective equipment and emergency procedures Avoid contact with eyes. Use personal protection equipment. 6.2 Environmental precautions Do not allow concentrated solutions to enter drainage system, surface or ground water. 6.3 Methods and material for containment and cleaning up Shovel up material and recycle if possible. Dispose of contaminated material according to the waste disposal recommendations. 6.4 Reference to other sections Refer to Section 8 for suitable PPE. Refer to Section 13 for disposal considerations. SECTION 7. Handling and storage 7.1 Precautions for safe handling Technical measures: sufficient ventilation and local suction is required in accordance with the details in the annex to the SDS. Do not eat, smoke or drink. 7.2 Conditions for safe storage, including any incompatibilities Tetrapotassium pyrophosphate is to be transported and stored in cool, dry conditions and in the original packaging. This product is hygroscopic. Do not store with acids. Do not use light alloy containers. 7.3 Specific end use(s) See annex for details of end uses covered in the exposure scenarios and CSR. The exposure scenarios detailed in the annex represent a worst case for exposure to humans and the environment. Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 5/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx SECTION 8. Exposure controls / personal protection 8.1 Control parameters 3 3 Workplace exposure limits: General dust exposure limit: 10 mg/m (inhalable fraction), 3 mg/m (alveolic fraction). German TRGS 900 (2006). [please check occupational limits for the country you supply to and insert limit here if available] DNELS (worker): Exposure route Inhalation Exposure pattern Acute systemic effects Long term systemic Dermal Acute systemic effects Long term systemic DNEL (workers) As no acute toxicity hazard has identified, there is no requirement to derive acute DNELs. Therefore only long term DNELs have been derived. 3 44.08 mg/m As no acute toxicity hazard has identified, there is no requirement to derive acute DNELs. Therefore only long term DNELs have been derived. As the substance to be registered is an inorganic solid, absorption through the skin is not an appropriate route of exposure. Dermal exposure will not result in systemic toxicity and therefore it is not considered to be appropriate to calculate a dermal DNEL. No DNELs can be derived for local effects as no dose-response relationship can be identified in any of the studies available. DNELs (general population): Exposure route Inhalation Exposure pattern Acute systemic effects Long term systemic Oral Acute systemic effects Long term systemic Dermal Revision date: X Acute systemic effects DNEL (general population) As no acute toxicity hazard has identified, there is no requirement to derive acute DNELs. Therefore only long term DNELs have been derived. 3 10.87 mg/m As no acute toxicity hazard has identified, there is no requirement to derive acute DNELs. Therefore only long term DNELs have been derived. Consumer uses of inorganic phosphates (sodium and potassium pyrophosphates) do not contribute to the oral intake of phosphates. Oral intake is predominately via food and water in the form of food additives or similar or from natural sources. It is therefore considered appropriate to use the Maximum tolerable daily intake (MTDI) value of 70 mg/kg bw /day of phosphorus as calculated by the Joint FAO/WHO Expert Committee on Food Additives (JEFCA) as any toxicity effects noted via the oral route are not attributable to the cation but are as a result of high doses of phosphates. As no acute toxicity hazard has identified, there is no requirement to derive acute DNELs. Therefore Version: XX NB. Please read the NOTICE on the front page Page 6/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx only long term DNELs have been derived. Long term systemic As the substance to be registered is an inorganic solid, absorption through the skin is not an appropriate route of exposure. Dermal exposure will not result in systemic toxicity and therefore it is not considered to be appropriate to calculate a dermal DNEL. No DNEL can be derived for local effects as no dose-response relationship can be identified in any of the studies available. PNECs: Compartment PNEC aqua (freshwater) PNEC aqua (marine water) PNEC aqua (intermittent releases) PNEC STP PNEC sediment (freshwater) PNEC sediment (marine water) PNEC soil Revision date: X PNEC Remarks No long-term toxicity studies are available and therefore the PNEC is based on the lowest value from the short-term 0.05 mg/L studies (100 mg/L), the assessment factor used takes the use of short-term data and read-across data into account. (AF = 2000) No reliable studies are available on marine species. The PNEC is therefore based on the short-term studies conducted 0.005 mg/L on freshwater species. The assessment factor used takes the use of short-term data in freshwater species and read-across data into account. (AF = 20000) The PNEC is based on the lowest value from the short-term 0.5 mg/L studies (100 mg/L), the assessment factor used takes the use of read-across data into account. (AF = 200) The PNEC is based on the NOEC from the ASRI study. The assessment factor used takes the use of read-across data into 50 mg/L account and uses the assessment factor appropriate for use of a NOEC value. (AF = 20) No data is available for freshwater sediments. Na+, K+, Mg2+, Ca2+ and PO43- ions are ubiquitous in the environment and are found naturally in soil, water and sediment. All are assimilated by species residing in the sediment, water or soil and are essential for maintaining a good chemical balance. It is therefore unlikely that inorganic phosphates of this nature would be toxic to sediment organisms and hence toxicity studies are scientifically unjustified. No data is available for marine sediments. Na+, K+, Mg2+, Ca2+ and PO43ions are ubiquitous in the environment and are found naturally in soil, water and sediment. All are assimilated by species residing in the sediment, water or soil and are essential for maintaining a good chemical balance. It is therefore unlikely that inorganic phosphates of this nature would be toxic to sediment organisms and hence toxicity studies are scientifically unjustified. No data is available for soil macroorganisms. Na+, K+, Mg2+, Ca2+ and PO43- ions are ubiquitous in the environment and are found naturally in soil, water and sediment. All are assimilated by species residing in the sediment, water or soil and are essential for maintaining a good chemical balance. Furthermore inorganic phosphate fertilizers (containing Na+, K+, Mg2+, Ca2+ and PO4- ions) are often added to soils to improve soil quality. Given the extensive use of inorganic phosphates as soil fertilizers and the natural occurrence of the ions in the environment it is unlikely that inorganic phosphates of this nature would have a detrimental effect on soil macroorganisms and plants and hence toxicity studies are scientifically unjustified. Version: XX NB. Please read the NOTICE on the front page Page 7/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate PNEC oral Date of issue: xxx Inorganic phosphates are not considered to pose a risk of secondary poisoning as they are unlikely to bioaccumulate due to the fact that they are not lipophillic and will therefore not accumulate in fatty tissues. It not considered necessary to derive a PNEC to take into account the risk of secondary poisoning and no further testing is considered necessary. 8.2 Exposure controls Appropriate engineering controls: Ensure work area is well ventilated or exhausted (where appropriate and in line with the exposure scenarios). Provide eye wash station. Respiratory protection: See annex for details of processes requiring respiratory protection. In case of insufficient ventilation, wear suitable respiratory device such as EN141 or EN405, Type A or Dust mask according to DIN EN 140 or 149 (FFP1 or FFP2). Skin protection: Laboratory coat or overalls and plastic or rubber boots. Store protective clothing separately. Eye protection: Tightly sealed chemical safety goggles (compliant with EN 166:2001) Hand protection: Wear protective gloves: In case of spray contact at least protection index 2 recommended, according to more than 30 min. penetration time (EN 374). Layer thickness of gloves at least: 0.4 mm In case of prolonged and intensive contact protection index 6 recommended, according to more than 480 min. penetration time (EN 374). Layer thickness of gloves at least: 0.7 mm Material of gloves: Butyl rubber, BR. Fluorocarbon rubber (Viton). Nitrile rubber, NBR. Natural rubber, NR. Chloroprene rubber, CR. Neoprene gloves Environmental controls: Refer to Sections 6, 7, 12 and 13 of the SDS. SECTION 9. Physical and chemical properties 9.1 Information on basic physical and chemical properties Property Value Method Appearance; including colour and physical state Odour Odour threshold pH Solid, white granules Observed Odourless Not available pH 10.7 – 10.9 Observed Melting point/freezing point >300°C In accordance with Annex XI, Section 1.2. of Regulation (EC) No. 1907/2006 (REACH) a weight of evidence approach has been used to fulfil the endpoint ‘Melting Point’. Initial boiling point and boiling range Not determined Flash point Not determined According to Regulation No. 1907/2006, a study for boiling point is not required for solids which melt above 300°C According to Regulation No. 1907/2006, the flash point does not need to be assessed for inorganic chemicals. Evaporation rate Not available Revision date: X Version: XX NB. Please read the NOTICE on the front page As measured in the water solubility study (EU Method A.6) Page 8/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Flammability (Solid, gas) Not flammable Upper/lower flammability or explosive limits Vapour pressure Not applicable Vapour density (Air = 1) Relative density Solubility(ies) Not applicable 2.61 at 21.0°C Date of issue: xxx Not determined Not determined Auto-ignition temperature No auto-ignition anticipated Not applicable Not determined Explosive properties Oxidising properties According to Regulation No. 1907/2006, a study for the vapour pressure need not be conducted if the melting point is above 300°C. EU Method A.3. EU Method A.6 Water: 67.2 to 69.9 % w/w at 20.0 A temperature range 10 to 30°C had no significant influence on the observed ± 0.5°C solubility of the test material. No effect of (very soluble) Partition coefficient: N-octanol/water Decomposition temperature Viscosity Based on prediction and use based observations Not considered to be explosive No oxidising properties pH was noted. According to Regulation No. 1907/2006, the partition coefficient n-octanol/water does not need to be assessed for inorganic chemicals. Based on prediction Testing not technically possible: According to the relevant OECD guideline (OECD 114) a study cannot be conducted on a substance that is a solid at room temperature. Prediction – in accordance with EU Method A14 Prediction – in accordance with EU Method A17 9.2 Other information Testing has been performed on tetrapotassium pyrophosphate, in accordance with Annex X of REACH. SECTION 10. Stability and reactivity 10.1 Reactivity Non-reactive under recommended storage and handling conditions. 10.2 Chemical stability Stable under recommended storage and handling conditions. 10.3 Possibility of hazardous reactions May react with strong acids. 10.4 Conditions to avoid None identified. 10.5 Incompatible materials Strong acids. Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 9/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx 10.6 Hazardous decomposition products None identified. SECTION 11. Toxicological information 11.1 Information on toxicological effects Toxicological endpoint Value (including relevance to CLP criteria) Method Acute toxicity LD50 = >2000 mg/kg bw/day. Not classified. In accordance with Annex XI, Section 1.2. of Regulation (EC) No. 1907/2006 (REACH) a weight of evidence approach has been used to fulfil the endpoint ‘Acute Oral Toxicity’ LD50 = 2000 mg/kg bw/day Rabbit, equivalent to OECD 402 Klimisch reliability 1 LC50 = > 1.1 mg/L Rat, EPA OPP 81-3, OECD 403, EU Method B.2. . Klimisch reliability 1. Rabbit, equivalent to OECD 404. Klimisch reliability 2 Rabbit, equivalent to OECD 405. Klimisch reliability 2 Mouse, OECD 429, EU Method B.42. Klimisch reliability 2 – read across from analogous substance. No data to suggest substance is a respiratory sensitiser. Tetrapotassium pyrophosphate is not expected to produce germ cell genotoxic damage. Not required for REACH. No data to suggest likelihood of carcinogenicity. Oral Dermal Inhalation Skin corrosion/irritation Serious eye/damage/irritation Respiratory or skin sensitisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity STOT-single exposure – all routes STOT-Repeated exposure - all routes Aspiration hazard Not irritating to skin Irritating to eyes – category 2. Non- sensitiser Not considered to be mutagenic. Not considered to be a carcinogen. Not considered to be a reproductive toxicant No STOT SE observed via the oral, dermal or inhalation route Not considered to induce specific organ toxicity after repeated exposure via oral route. NOAEL: 500 mg/kg bw/day No aspiration hazard identified OECD Guideline 408 (Repeated Dose 90Day Oral Toxicity in Rodents), Klimisch reliability 2 (read-across from analogous substance). Not applicable. The substance has been assessed with regards to the data requirements of Annex X of REACH. SECTION 12. Ecological information Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 10/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx 12.1 Toxicity Toxicological endpoint Acute fish toxicity Value (including relevance to CLP criteria) 96 hr LC50 = > 100 mg/L 96 hr NOEC = 100 mg/L Species, Method Rainbow trout, OECD 203, EU Method C.1. Conducted on analogous substance, reliability 2. Daphnia magna, OECD 202, EU Method Acute Daphnia toxicity 48 hr EC50 = > 100 mg/L 48 hr NOEC = >100 mg/L C.2. Conducted on analogous substance, reliability 2. 72 hr EC50 = > 100 mg/L 72 hr NOEC = >100 mg/L Algal growth inhibition Desmodesmus subspicatus (algae), OECD 201, EU Method C.3. Conducted on analogous substance, Basis for effect: growth rate reliability 2. Activated sludge of a predominantly domestic sewage, OECD 209, EU Method Activated Sludge Respiration 3 hr EC50 = > 1000 mg/L C.11, EPA OPPTS 850.6800. 3 hr NOEC = 1000 mg/L Conducted on analogous substance, reliability 2. The substance has been assessed with regards to the data requirements of Annex X of REACH 12.2 Persistence and degradability Tetrapotassium pyrophosphate is an inorganic substance, biodegradation studies are not applicable. No further testing is deemed to be necessary. 12.3 Bioaccumulative potential Tetrapotassium pyrophosphate hydrolyses to orthophosphate and sodium ions in aqueous and biological systems. The degradation products of tetrapotassium pyrophosphate are essential nutrients (food elements) for plants, and stimulate the growth of water plants (macrophytes) and/or algae (phytoplankton) and are ubiquitous in the environment. The potential for bioaccumulation is therefore considered to be minimal. 12.4 Mobility in soil No data available: A batch equilibrium study according to OECD Guideline 106 was deemed to be not applicable to Tetrapotassium pyrophosphate for the following reasons: Firstly, analysis of the test material may not be possible due to interference from the soil extracts that may leach into the aqueous media during the test. This would prevent quantification of the test material. In addition, the mobility of the test item would be dependent on the anion exchange capacity of the soils as the main component of the test material is an anion. This absorption relationship would not be anticipated to correlate with the organic carbon content of the soils and is considered to be beyond the scope of the OECD 106 method. Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 11/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx 12.5 Results of PBT and vPvB assessment According to the Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.11: PBT Assessment, the PBT and vPvB criteria of Annex XIII to the regulation do not apply to inorganic substances. Therefore tetrapotassium pyrophosphate is not considered to require any further assessment of PBT properties. 12.6 Other adverse effects No sediment or terrestrial toxicity data exists. Substance is not considered to be hazardous to sediment dwelling or terrestrial organisms. According to the criteria of the European classification and labelling system, the substance does not require classification as hazardous for the environment SECTION 13. Disposal considerations 13.1 Waste treatment methods Disposal recommendations are made based on the material as supplied. Disposal must be in accordance with current applicable laws and regulations. Disposal of substance: Dispose of in accordance with national and local regulations for special waste via an appropriately licensed waste contractor. Do not discharge to drains or STP. Disposal of packaging: Empty containers and clean out appropriately before reuse or disposal. Packaging may be recycled if thoroughly cleaned. Packaging that cannot be cleaned should be disposed of according to national and local regulations for special waste via an appropriately licensed waste contractor. Regulatory disposal information: European waste codes: Waste producers need to assess the process used when generating the waste and its contaminants in order to assign the most appropriate waste disposal code(s). Recommended code: European waste catalogue 16 03 03 inorganic wastes containing dangerous substances SECTION 14. Transport information Transport classifications (ADR/RID/IMDG/IATA) are not defined in the REACH Registration Dossier for the substance. The information provided here is therefore not derived from this Dossier and is based on other information available to the Consortium Members. The Transport classifications (ADR/RID/IMDG/IATA) provided here are indicative and based on the data in the REACH dossier for the pure substance only and may not be applicable for solutions or other preparations. Please seek advice from your Dangerous Good Safety Advisor. According to information available: UN transport classification: Not Classified (for pure substance as solid and solution in water 14.1 UN number LAND (ADR/RID) Revision date: X SEA (IMDG) Version: XX NB. Please read the NOTICE on the front page AIR (IATA) Page 12/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx 14.2 UN proper shipping name 14.3 Transport hazard class(es) Labels 14.4 Packing group 14.5 Environmental hazards 14.6 Special precautions for user 14.7 Transport in bulk according to Annex II of MARPOL 73/78 and the IBC code Other Information: SECTION 15. Regulatory information 15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture. [COMPANY TO INCLUDE ANY INFORMATION RELEVANT TO THE COUNTRY OF PRODUCT AND/OR SUPPLY] This safety data sheet is compliant with Regulation (EC) No 1907/2006 (REACH) (including the amendment, Regulation (EU) No 453/2010 and Regulation (EC) No. 1272/2008 (EU CLP). 15.2 Chemical Safety Assessment. A Chemical Safety Assessment is available for tetrapotassium pyrophosphate. SECTION 16. Other information This SDS supersedes the SDS dated [TO BE COMPLETED BY COMPANY SUPPLYING SDS] The following amendments have been made: - SDS has been fully revised and re-written in accordance with Regulation (EU) No 453/2010 and Regulation (EC) No. 1272/2008 (EU CLP). - Any further amendments to be detailed by supplier of SDS Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 13/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx Sources of Key data used: - Registration dossier submitted to ECHA in accordance with Regulation (EC) No. 1907/2006 and therefore a full reference list can be found in the corresponding CSR. Abbreviations and acronyms used: AF = Assessment factor DNEL = Derived no effect level EC50 = Median effect concentration LC50 = Median lethal concentration LD50 = Median lethal dose LEV = Local Exhaust Ventilation NOAEL = No observed adverse effect level NOEC = No observed effect concentration PBT Persistent bioaccumulative toxic PEC = Predicted effect level PNEC = Predicted no effect level PRE = Personal Respiratory Equipment OEL = Occupational Exposure Limit SDS = Safety data sheet STOT–SE = Specific target organ toxicity – single exposure STOT–RE = Specific target organ toxicity – repeated exposure STP = Sewage treatment plant vPvB = Very persistent very bioaccumulative Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 14/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx Annex: summary of relevant exposure scenarios Annex: summary of relevant exposure scenarios ...........................................................15 ES1: Manufacture of TKPP ............................................................................................15 ES2: Mixing TKPP into final products.............................................................................19 ES3: Use as raw material, process aid and laboratory agent in chemical synthesis .......29 ES4: Use of TKPP and products containing TKPP for treatment and finishing of metals ..............................................................................................................35 ES5: Leather and textiles manufacturing and treatment with products containing TKPP ...............................................................................................................45 ES6: Use of TKPP and products containing TKPP for water and wastewater treatment..........................................................................................................51 ES7: Industrial and professional use of washing and cleaning products containing TKPP ...............................................................................................................61 ES8: Application in oil well and other drilling fluid applications, liquefying and conditioning earths, mud, clays ........................................................................72 ES9: Professional and consumer use of TKPP and products and materials containing TKPP in ceramic manufacture and construction and building work .................................................................................................................78 ES10: Professional and consumer use of TKPP and products containing TKPP in fertiliser products..............................................................................................88 ES11: Consumer use of detergents ...............................................................................93 ES12: Consumer use of cosmetics, toothpaste and other products containing TKPP ....95 ES1: Manufacture of TKPP 1. Short title of exposure scenario 1 Manufacture of TKPP 2. Description of activities and processes covered in the exposure scenario Sector of use (SU) Product category (PC) Process category (PROC) Article category (AC) Environmental release category Revision date: X SU 3: Industrial uses: uses of substances as such or in preparations at industrial sites SU 8: Manufacture of bulk, large scale chemicals (including petroleum products). SU 9: Manufacture of fine chemicals. Not applicable PROC 1: Use in closed process, no likelihood of exposure PROC 2: Use in closed, continuous process with occasional controlled exposure. PROC 8b: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities. PROC 9: Transfer of substance or preparation into small containers (dedicated filling line, including weighing). PROC 26: Handling of solid inorganic substances at ambient temperature. Not applicable ERC 1: Manufacture of substances Version: XX NB. Please read the NOTICE on the front page Page 15/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx (ERC) 3. Operational conditions 3. 1 Operational conditions related with frequency and quantities of use Duration of exposure at workplace: 24 hours/day (3 working shifts of 8 hours/shift) Frequency of exposure at workplace: 365 days/year for each worker Annual amount used per site: The daily and annual amount/emission per site is not considered to be the main determinant for environmental exposure. 3.2 Operational conditions related with substance/ product Physical state Solid / Liquid Concentration of substance in mixture In the first-tier assessment of exposure, A concentration of 100% w/w was used to assess exposure to the solid substance. The concentration of TKPP in solutions was assumed to be > 25%. 3.3 Other relevant operational conditions Processes may be operated on 365 days a year for 24 hours a day divided into three working shifts. A single worker may be exposed on 220 days per year. No information about frequency and duration of the various tasks is available. In the first-tier assessment of exposure a frequency of once a day and an exposure duration of 8 hours was considered. 4. Risk Management Measures 4.1 RMMs related to workers Organisational measures The employer must ensure that the required PPE is available and used according to instructions (provide training if necessary). PPE are required when breaching the system or handling the pure substance and concentrated solutions. Eye wash stations should be available in case of accidental contact. Technical measures Respiratory protection Hand protection Revision date: X Transport over pipes, technical barrel filling/emptying of barrel with automatic systems (suction pumps etc.) (Good practice) Use of pliers, grip arms with long handles with manual use “to avoid direct contact and exposure by splashes (no working over one’s head)” (Good practice) Store in cool, dry, clean, well ventilate areas. (Good practice). Local exhaust / general ventilation should be present when solids are handled to reduce the likelihood of inhalation exposure to dusts. Workers wear appropriate personal protective equipment, such as gloves, breathing masks and safety glasses when breaching the system or else being in contact with the undiluted substance. Respiratory protection: Respiratory protection is required when workers are exposure to dusts, if LEV with a suitable efficiency (see table below) is not available. Exposure to dusts from the handling of solid materials should be reduced by the use of local exhaust ventilation (efficiency of at least 90%). Some processes occurring outdoors may require respiratory protection. If local exhaust ventilation is not available then it will be necessary to use personal respiratory protection that is compliant with EN141 or EN 405. Hand protection is recommended: impervious chemical resistant protective gloves. Material: Material of gloves: Butyl rubber, BR. Fluorocarbon rubber (Viton). Nitrile rubber, NBR. Natural rubber, NR. Chloroprene rubber, CR. Neoprene gloves. Version: XX NB. Please read the NOTICE on the front page Page 16/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Eye protection Date of issue: xxx Workers handling concentrated TKPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. Goggles or face protection shield should be consistent with EN 166 or equivalent. Skin and body protection Wearing of suitable protective clothing and rubber boots is recommended. Hygiene measures Keep away from foodstuffs, drinks and tobacco. Wash hands before breaks and at end of work. Keep work clothes separate. 4.2 RMMs related to the environment Organisational measures Emissions to the environment must meet the requirements of Council Directive 96/61/EC and National Regulations concerning phosphate in industrial wastewater. Abatement measures related with wastewater The efficiency of the process is maximised in such a way that minimal emission of phosphates into the wastewater will occur. In addition, phosphate can be precipitated from the wastewater by addition of metal ions. Abatement measures waste air and solid waste Emissions of particles into the air of workplaces or the atmosphere can be significantly reduced by the use of cyclones, gas scrubbers or bag filters. Solid and liquid waste has to be incinerated or appropriately disposed of as chemical waste. 4.3 Waste related measures Type of waste Liquid waste, solid residues. Disposal technique The release of phosphates to wastewater is highly regulated.The residue of the containers or the used container itself should be disposed in accordance with local requirements. See Section 13 of the SDS for more information. Fraction released to environment during waste treatment Not determined. 5. Prediction of exposure and comparison of predicted exposure with DNELs (Risk Characterisation) 5.1. Human exposure Exposure estimation tool(s) Workers (oral) Workers (inhalation) DNEL: Worker, longterm, systemic, inhalation: 3 44.08 mg/m General dust exposure limit: 3 10 mg/m Revision date: X ECETOC TRA (2010). MEASE(EBRC, Eurometaux, 2010): Used to assess exposure to inorganic solutions and handling of solid inorganics (PROC 26). The manufacture and processing of TKPP will not notably contribute to the oral intake of phosphates. It is also considered that workplace exposure limits for dust are applicable to this substance in the countries in which the substance is manufactured and used. Therefore, the exposure estimates will also be compared against a relevant general dust limit for an inhalable fraction of 10 mg/m3 as described by the occupational exposure limits detailed in the Technical Rules for Hazardous Materials – TRGS 900, January 2006 (Germany).This applies to both industrial and professional use as although the two settings are not directly comparable, it may be prudent to assess both the DNEL and the industrial against the same values both for consistency and for worker safety. A comparison of both the DNEL and a dust limit will ensure that downstream users have enough information on the required RMMs to ensure safe use in line with regional or national limits. A number of industrial activities associated with the manufacture and processing of TKPP may result in inhalation exposure of workers to the substance. The risk characterisation ratios for these activities are given in the table below. Workers handling concentrated Version: XX NB. Please read the NOTICE on the front page Page 17/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx TKPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. The use of appropriate gloves and working suits is recommended. It is concluded that conditions can be defined under which the potential health risks from the manufacture and processing of TKPP are adequately controlled. Exposure scenario: Risk characterisation of manufacturing and processing of TKPP Activity type: Industrial Location: Indoors LEV Duration (hours) 1 No >4 2 No >4 8b No >4 9 No >4 1 No >4 2 No >4 8b No >4 9 No >4 26 No >4 1 No >4 2 No >4 8b No >4 9 No >4 26 No >4 1 No >4 2 No >4 No >4 95% >4 No >4 90% >4 No >4 75% >4 8b 9 26 Workers Revision date: X Airborne TKPP RCR PRE Conclusion conc. (DNEL) 3 (mg/m ) Activities performed with TKPP solutions Risk 0.001 No > 25 2.269E-05 Controlled Risk 0.001 No > 25 2.269E-05 Controlled Risk 0.01 No > 25 0.0002269 Controlled Risk 0.01 No > 25 0.0002269 Controlled Activities performed with solids of low dustiness Risk 0.01 No 100 0.0002269 Controlled Risk 0.01 No 100 0.0002269 Controlled Risk 0.10 No 100 0.0022686 Controlled Risk 0.10 No 100 0.0022686 Controlled Risk 1.50 Controlled No 100 0.034029 Activities performed with solids of medium dustiness Risk 0.01 No 100 0.0002269 Controlled Risk 0.50 Controlled No 100 0.011343 Risk 5.00 No 100 0.1134301 Controlled Risk 5.00 No 100 0.1134301 Controlled Risk 4.00 No 100 0.0907441 Controlled Activities performed with solids of high dustiness Risk 0.01 No 100 0.0002269 Controlled Risk 1.00 Controlled No 100 0.022686 Risk 25.00 No 100 0.5671506 Controlled Risk No 100 1.25 0.0283575 Controlled Risk 20.00 No 100 0.4537205 Controlled Risk No 100 2.00 0.0453721 Controlled Risk 10.00 No 100 0.2268603 Controlled Risk No 100 2.50 0.0567151 Controlled Process Category Weight fraction (%) RCR (OEL) 0.0001 0.0001 0.001 0.001 0.001 0.001 0.01 0.01 0.15 0.001 0.05 0.5 0.5 0.4 0.001 0.1 2.5 0.125 2 0.2 1 0.25 Conclusion Risk Controlled Risk Controlled Risk Controlled Risk Controlled Risk Controlled Risk Controlled Risk Controlled Risk Controlled Risk Controlled Risk Controlled Risk Controlled Risk Controlled Risk Controlled Risk Controlled Risk Controlled Risk Controlled RMMs required Risk Controlled RMMs required Risk Controlled RMMs required Risk Controlled No systemic toxicity effects are expected due to the inorganic nature of the substance Version: XX NB. Please read the NOTICE on the front page Page 18/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx (dermal) however local effects may occur but these effects will not be dose-dependent but will depend on the concentration of the substance present in the mixture/solution used in a specific application. Indirect exposure via the environment No indirect exposure of humans via the environment is expected for TKPP, as the substance can be effectively removed from the wastewater. Thus, no assessment of indirect exposure of humans via the environment is performed. Consumer exposure No direct consumer exposure is anticipated with the manufacture and processing of TKPP. It is concluded that the manufacture and processing of TKPP is of no risk for the general public. 5.2. Environmental exposure (qualitative assessment) Environmental release The production of TKPP can potentially result in aquatic emissions and locally increase the 3phosphate (PO4 ) concentration. Phosphates reaching surface water increase the phosphorus content in the water body which may cause eutrophication and water quality deterioration. Waste water treatment plants (WWTP) Phosphorus should be removed from industrial wastewater before it is released to the environment. This can be done by chemical treatment (by precipitation with the help of aluminium or iron addition) or biological treatments. A high degree of removal can be reliably achieved by the available phosphorus removal techniques. Site-specific conditions such as flow rate of the receiving surface water body and phosphorus concentration in the receiving surface water body should be taken into account when implementing an appropriate wastewater treatment. Council Directive 96/61/EC concerning integrated pollution prevention and control and national regulations concerning phosphates in industrial wastewater have to be followed to minimise the risk of eutrophication due to phosphate releases. Aquatic pelagic compartment No direct acute or long-term adverse effects on aqueous or terrestrial organisms are anticipated with orthophosphates in the environment. Sediments No direct acute or long-term adverse effects on aqueous or sediment organisms are anticipated with orthophosphates in the environment. Soil and groundwater No direct acute or long-term adverse effects on terrestrial organisms are anticipated with orthophosphates in the environment. Atmospheric compartment The manufacture of TKPP is not considered to pose a risk to the atmospheric compartment. Secondary poisoning Bioaccumulation in organisms is not relevant for inorganic phosphates. ES2: Mixing TKPP into final products 1. Short title of exposure scenario 2 Mixing TKPP into final products 2. Description of activities and processes covered in the exposure scenario Sector of use (SU) SU 3: Industrial uses SU 10: Formulation [mixing] of preparations and/or re-packaging (excluding alloys) SU 13: Manufacture of other non-metallic mineral products, e.g. plasters, cement SU 11: Manufacture of rubber products SU 14: Manufacture of basic metals, including alloys Product category (PC) PC 1: Adhesives, sealants PC 0: Other: Food and feed product PC 3: Air care products Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 19/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx PC 7: Base metals and alloys PC 8: Biocidal products (e.g. disinfectants, pest control) PC 9a: Coatings and paints, thinners, paint removes PC 9b: Fillers, putties, plasters, modelling clay PC 9c: Finger paints PC 12: Fertilisers PC 14: Metal surface treatment products, including galvanic and electroplating products PC 15: Non-metal-surface treatment products PC 16: Heat transfer fluids PC 17: Hydraulic fluids PC 18: Ink and toners PC 20: Products such as ph-regulators, flocculants, precipitants, neutralisation agents PC 21: Laboratory chemicals PC 23: Leather tanning, dye, finishing, impregnation and care products PC 24: Lubricants, greases, release products PC 26: Paper and board dye, finishing and impregnation products: including bleaches and other processing aids PC 27: Plant protection products PC 29: Pharmaceuticals PC 32: Polymer preparations and compounds PC 34: Textile dyes, finishing and impregnating products; including bleaches and other processing aids PC 35: Washing and cleaning products (including solvent based products) PC 36: Water softeners PC 37: Water treatment chemicals PC 39: Cosmetics, personal care products Process category (PROC) PROC 1: Use in closed process, no likelihood of exposure PROC 2: Use in closed, continuous process with occasional controlled exposure PROC 3: Use in closed batch process (synthesis or formulation) PROC 4: Use in batch and other process (synthesis) where opportunity for exposure arises PROC 5: Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact) PROC 7: Industrial spraying PROC 8a: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities PROC 8b: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities PROC 9: Transfer of substance or preparation into small containers (dedicated filling line, including weighing) PROC 14: Production of preparations or articles by tabletting, compression, extrusion, pelletisation PROC 15: Use as laboratory reagent PROC 21: Low energy manipulation of substances bound in materials and/or articles PROC 22: Potentially closed processing operations with minerals/metals at elevated temperature. Industrial setting PROC 23: Open processing and transfer operations with minerals/metals at elevated temperature PROC 24: High (mechanical) energy work-up of substances bound in materials and/or articles PROC 26: Handling of solid inorganic substances at ambient temperature Article category (AC) Environmental release category (ERC) Not applicable Revision date: X ERC 1: Manufacture of substances ERC 2: Formulation of preparations ERC 3: Formulation in materials ERC 4: Industrial use of processing aids in processes and products, not becoming part of articles ERC 5: Industrial use resulting in inclusion into or onto a matrix Version: XX NB. Please read the NOTICE on the front page Page 20/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx ERC 6a: Industrial use resulting in manufacture of another substance (use of intermediates) ERC 6b: Industrial use of reactive processing aids ERC 6d: Industrial use of process regulators for polymerisation processes in production of resins, rubbers, polymers ERC 8a: Wide dispersive indoor use of processing aids in open systems ERC 8b: Wide dispersive indoor use of reactive substances in open systems 3. Operational conditions 3. 1 Operational conditions related with frequency and quantities of use Duration of exposure at workplace: No information about frequency and duration of the various tasks is available. In the firsttier assessment of exposure a frequency of once a day and an exposure duration of 8 hours was considered. A single worker may be exposed on 220 days a year. Frequency of exposure at workplace: Annual amount used per site: The daily and annual amount/emission per site is not considered to be the main determinant for environmental exposure. 3.2 Operational conditions related with substance/ product Physical state Solid / Liquid Concentration of substance in mixture No information about the concentration of the substance in solutions or in solids is available. In the first-tier assessment of exposure a concentration of 100% w/w was used to assess exposure to the solid raw material and a concentration of >25% w/w was used to assess exposure to the aqueous solutions. 3.3 Other relevant operational conditions No information about frequency and duration of the various tasks is available. In the first-tier assessment of exposure a frequency of once a day and an exposure duration of 8 hours was considered. A single worker may be exposed on 220 days a year. No information about the concentration of the substance in solutions or in solids is available. No information about the concentration of the substance in solutions or in solids is available. In the first-tier assessment of exposure a concentration of 100% w/w was used to assess exposure to the solid raw material and a concentration of >25% w/w was used to assess exposure to the aqueous solutions. 4. Risk Management Measures 4.1 RMMs related to workers Organisational measures The employer must ensure that the required PPE is available and used according to instructions (provide training if necessary). PPE are required when breaching the system or handling the pure substance and concentrated solutions. Eye wash stations should be available in case of accidental contact. Technical measures Respiratory Revision date: X Transport over pipes, technical barrel filling/emptying of barrel with automatic systems (suction pumps etc.) (Good practice) Use of pliers, grip arms with long handles with manual use “to avoid direct contact and exposure by splashes (no working over one’s head)” (Good practice) Store in cool, dry, clean, well ventilate areas. (Good practice). Local exhaust / general ventilation should be present when solids are handled to reduce the likelihood of inhalation exposure to dusts. Workers wear appropriate personal protective equipment, such as gloves, breathing masks and safety glasses when breaching the system or else being in contact with the undiluted substance. Respiratory protection: Respiratory protection is required when workers are exposure to dusts, if LEV with a suitable efficiency (see table below) is not available. Exposure to dusts Version: XX NB. Please read the NOTICE on the front page Page 21/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate protection Date of issue: xxx from the handling of solid materials should be reduced by the use of local exhaust ventilation (efficiency of at least 90%). Some processes occurring outdoors may require respiratory protection. If local exhaust ventilation is not available then it will be necessary to use personal respiratory protection that is compliant with EN141 or EN 405. Hand protection Hand protection is recommended: impervious chemical resistant protective gloves. Material: Material of gloves: Butyl rubber, BR. Fluorocarbon rubber (Viton). Nitrile rubber, NBR. Natural rubber, NR. Chloroprene rubber, CR. Neoprene gloves. Eye protection Workers handling concentrated TKPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. Goggles or face protection shield should be consistent with EN 166 or equivalent. Skin and body protection Wearing of suitable protective clothing and rubber boots is recommended. Hygiene measures Keep away from foodstuffs, drinks and tobacco. Wash hands before breaks and at end of work. Keep work clothes separate. 4.2 RMMs related to the environment Organisational measures Emissions to the environment must meet the requirements of Council Directive 96/61/EC and National Regulations concerning phosphate in industrial wastewater. Abatement measures related with wastewater The efficiency of the process is maximised in such a way that minimal emission of phosphates into the wastewater will occur. In addition, phosphate can be precipitated from the wastewater by addition of metal ions. Abatement measures waste air and solid waste Emissions of particles into the air of workplaces or the atmosphere can be significantly reduced by the use of cyclones, gas scrubbers or bag filters. Solid and liquid waste has to be incinerated or appropriately disposed of as chemical waste. 4.3 Waste related measures Type of waste Liquid waste, solid residues. Disposal technique The release of phosphates to wastewater is highly regulated. The residue of the containers or the used container itself should be disposed in accordance with local requirements. See Section 13 of the SDS for more information. Not determined. Fraction released to environment during waste treatment 5. Prediction of exposure and comparison of predicted exposure with DNELs (Risk Characterisation) 5.1. Human exposure Exposure estimation tool(s) ECETOC TRA (2010). Workers (oral) The use of TKPP in the mixing of final products will not notably contribute to the oral intake of phosphates. Workers (inhalation) DNEL: Revision date: X MEASE(EBRC, Eurometaux, 2010): Used to assess exposure to inorganic solutions and handling of solid inorganics (PROC 26). It is also considered that workplace exposure limits for dust are applicable to this substance in the countries in which the substance is manufactured and used. Therefore, the exposure estimates will also be compared against a relevant general dust limit for an Version: XX NB. Please read the NOTICE on the front page Page 22/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Worker, longterm, systemic, inhalation: 3 44.08 mg/m General dust exposure limit: 3 10 mg/m Date of issue: xxx inhalable fraction of 10 mg/m3 as described by the occupational exposure limits detailed in the Technical Rules for Hazardous Materials – TRGS 900, January 2006 (Germany).This applies to both industrial and professional use as although the two settings are not directly comparable, it may be prudent to assess both the DNEL and the industrial against the same values both for consistency and for worker safety. A comparison of both the DNEL and a dust limit will ensure that downstream users have enough information on the required RMMs to ensure safe use in line with regional or national limits. A number of industrial activities associated with the the mixing of TKPP into final products may result in inhalation exposure of workers to the substance. The risk characterisation ratios for these activities are given in the table below. Workers handling concentrated TKPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. The use of appropriate gloves and working suits is recommended. It is concluded that conditions can be defined under which the potential health risks from the manufacture and processing of TKPP are adequately controlled. Exposure scenario: Risk characterisation for the mixing of TKPP into final products. Activity type: Industrial Location: Indoors (In) and outdoors (Out) No >4 Out* 30% >4 In No >4 Out* 30% >4 In No >4 Out* 30% >4 In No >4 Out* 30% >4 In No >4 In 90% >4 In No >4 Out* 30% >4 Out* 30% >4 In No >4 Out* In 30% No >4 >4 Version: XX NB. Please read the NOTICE on the front page Conclusion In RCR (OEL) >4 Conclusion Revision date: X 30% RCR (DNEL) 8b 9 Out* Airborne TKPP conc. (mg/m3) 7 >4 Weight fraction (%) 5 No PRE 4 Time 3 LEV (% efficiency) 2 Indoors/ Outdoors Process Category 1 In Activities performed with TKPP solutions Risk 2.27E0.001 controlled No > 25 05 Risk 1.59Econtrolled No > 25 0.0007 05 Risk 2.27E0.001 controlled No > 25 05 Risk 1.59Econtrolled No > 25 0.0007 05 Risk 0.01 controlled No > 25 0.0002 Risk controlled No > 25 0.007 0.0002 Risk 0.05 controlled No > 25 0.001 Risk controlled No > 25 0.035 0.0008 Risk 0.05 controlled No > 25 0.001 Risk controlled No > 25 0.035 0.0008 Risk 20.00 controlled No > 25 0.454 Risk controlled No > 25 2.00 0.045 Risk controlled 75% > 25 5.00 0.113 Risk controlled No > 25 14.00 0.318 Risk controlled 75% > 25 3.50 0.079 Risk 0.01 controlled No > 25 0.0002 Risk controlled No > 25 0.007 0.0002 0.01 Risk No > 25 0.0002 0.0001 0.00007 0.0001 0.00007 0.001 0.0007 0.005 0.004 0.005 0.004 2 0.2 0.5 1.4 0.35 0.001 0.0007 0.001 Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk Page 23/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate 14 15 1 2 Out* 30% In No Out* 30% In No Out* 30% In No Out 30% In No Out 30% In No Out 30% In No Out 30% In No Out 30% In No Out 30% In No Out 30% In No Out 30% In No Out 30% In No Out 30% In No Out 30% In No Out 30% In No Out 30% 3 4 5 7 8b 9 14 15 21 22a pt<mp Low Fugacity 22b pt ≈ mp - Med Fugacity Revision date: X Date of issue: xxx controlled Risk controlled >4 No > 25 0.007 0.0002 Risk 0.01 controlled >4 No > 25 0.0002 Risk controlled >4 No > 25 0.007 0.0002 Risk 0.01 controlled >4 No > 25 0.0002 Risk controlled >4 No > 25 0.007 0.0002 Activities performed with solids of low dustiness Risk 0.01 controlled >4 No 100 0.0002 Risk controlled >4 No 100 0.007 0.0002 Risk 0.01 controlled >4 No 100 0.0002 Risk controlled >4 No 100 0.007 0.0002 Risk 0.10 controlled >4 No 100 0.0023 Risk controlled >4 No 100 0.07 0.0016 Risk 0.50 controlled >4 No 100 0.0113 Risk controlled >4 No 100 0.35 0.0079 Risk 0.50 controlled >4 No 100 0.0113 Risk controlled >4 No 100 0.35 0.0079 Risk 1.00 controlled >4 No 100 0.0227 Risk controlled >4 No 100 0.70 0.0159 Risk 0.10 controlled >4 No 100 0.0023 Risk controlled >4 No 100 0.07 0.0016 Risk 0.10 controlled >4 No 100 0.0023 Risk controlled >4 No 100 0.07 0.0016 Risk 0.10 controlled >4 No 100 0.0023 Risk controlled >4 No 100 0.07 0.0016 Risk 0.10 controlled >4 No 100 0.0023 Risk controlled >4 No 100 0.07 0.0016 Risk 1.00 controlled >4 No 100 0.0227 Risk controlled >4 No 100 0.70 0.0159 Risk 1.00 controlled >4 No 100 0.0227 Risk controlled >4 No 100 0.70 0.0159 Risk 3.00 controlled >4 No 100 0.0681 Risk controlled >4 No 100 2.10 0.0476 Version: XX NB. Please read the NOTICE on the front page 0.0007 0.001 0.0007 0.001 0.0007 0.001 0.0007 0.001 0.0007 0.01 0.007 0.05 0.035 0.05 0.035 0.1 0.07 0.01 0.007 0.01 0.007 0.01 0.007 0.01 0.007 0.1 0.07 0.1 0.07 0.3 0.21 controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Page 24/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx Risk controlled Risk controlled >4 No 100 1.00 0.0227 Risk controlled >4 No 100 7.00 0.1588 Risk 1.00 controlled >4 No 100 0.0227 Risk controlled >4 No 100 0.70 0.0159 Risk 3.00 controlled >4 No 100 0.0681 Risk controlled >4 No 100 2.10 0.0476 Risk 10.00 controlled >4 No 100 0.2269 Risk controlled >4 No 100 1.00 0.0227 Risk controlled >4 No 100 7.00 0.1588 Risk 1.00 controlled >4 No 100 0.0227 Risk controlled >4 No 100 0.70 0.0159 Risk 3.00 controlled >4 No 100 0.0681 Risk controlled >4 No 100 2.10 0.0476 Risk 10.00 controlled >4 No 100 0.2269 Risk controlled >4 No 100 2.00 0.0454 Risk controlled >4 No 100 7.00 0.1588 Risk 1.50 controlled >4 No 100 0.0340 Risk controlled >4 No 100 1.05 0.0238 Activities performed with solids of medium dustiness Risk 0.01 >4 No 100 0.0002 controlled Risk >4 No 100 0.007 0.0002 controlled No In 90% Out 30% In No Out 30% In No Out 30% In No In 90% Out 30% 24a Low Fugacity In No Out 30% 24b Med Fugacity In No Out 30% In No In 80% Out 30% In No Out* 30% In No Out 30% In No >4 No 100 0.50 0.011 Out 30% >4 No 100 0.35 0.008 In No >4 No 100 1.00 0.023 Out 30% >4 No 100 0.70 0.016 In No >4 No 100 5.00 0.113 Out 30% >4 No 100 3.50 0.079 In No >4 No 100 5.00 0.113 Out 30% >4 No 100 3.50 0.079 In No >4 No 100 20.00 0.454 In 95% >4 No 100 1.00 0.023 Out Out 30% 30% >4 >4 No 90% 100 100 14.00 1.40 0.318 0.032 22c pt > mp - High Fugacity 23a pt<mp Low Fugacity 23b pt ≈ mp - Med Fugacity 23c pt > mp - High Fugacity 24c High Fugacity 26 1 2 3 4 >4 No 100 10.00 In 0.2269 5 7 Revision date: X Version: XX NB. Please read the NOTICE on the front page Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk 1 0.1 0.7 0.1 0.07 0.3 0.21 1 0.1 0.7 0.1 0.07 0.3 0.21 1 0.2 0.7 0.15 0.105 0.001 0.0007 0.05 0.035 0.1 0.07 0.5 0.35 0.5 0.35 2 0.1 1.4 0.14 RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled RMMs required Risk Page 25/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx In No >4 No 100 5.00 0.113 Out 30% >4 No 100 3.50 0.079 In No >4 No 100 5.00 0.113 Out 30% >4 No 100 3.50 0.079 In No >4 No 100 1.00 0.023 Out 30% >4 No 100 0.70 0.016 In No >4 No 100 0.50 0.011 Out 30% >4 No 100 0.35 0.008 In No >4 No 100 3.00 0.068 21 Out 30% >4 No 100 2.10 0.048 22a pt<mp Low Fugacity In No >4 No 100 1.00 0.023 Out 30% >4 No 100 0.07 0.002 22b pt ≈ mp - Med Fugacity In No >4 No 100 3.00 0.068 Out 30% >4 No 100 2.10 0.048 In No >4 No 100 10.00 0.227 In 90% >4 No 100 1.00 0.023 Out 30% >4 No 100 7.00 0.159 In No >4 No 100 1.00 0.023 Out 30% >4 No 100 0.70 0.016 In No >4 No 100 3.00 0.068 Out 30% >4 In No In 90% Out 30% 24a Low Fugacity In No Out 30% 24b Med Fugacity In No Out 30% In No In 80% Out 30% In No Out* No In No 8b 9 14 15 22c pt ≈ mp – High Fugacity 23a pt<mp Low Fugacity 23b pt ≈ mp - Med Fugacity 23c pt > mp - High Fugacity 24c High Fugacity 26 1 Revision date: X controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk 10.00 >4 No 100 0.227 controlled Risk >4 No 100 1.00 0.023 controlled Risk >4 No 100 7.00 0.159 controlled Risk 1.00 >4 No 100 0.023 controlled Risk >4 No 100 0.70 0.016 controlled Risk 3.00 >4 No 100 0.068 controlled Risk >4 No 100 2.10 0.048 controlled Risk 10.00 >4 No 100 0.227 controlled Risk >4 No 100 2.00 0.045 controlled Risk >4 No 100 7.00 0.159 controlled Risk 4.00 >4 No 100 0.091 controlled Risk >4 No 100 2.80 0.064 controlled Activities performed with solids of high dustiness Risk 0.01 >4 No 100 0.0002 controlled No 100 Version: XX NB. Please read the NOTICE on the front page 2.10 0.048 0.5 0.35 0.5 0.35 0.1 0.07 0.05 0.035 0.3 0.21 0.1 0.007 0.3 0.21 1 0.1 0.7 0.1 0.07 0.3 controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled 0.28 Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled 0.001 Risk controlled 0.21 1 0.1 0.7 0.1 0.07 0.3 0.21 1 0.2 0.7 0.4 Page 26/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate 2 3 4 5 7 8b 9 14 15 21 22a pt<mp Low Fugacity Revision date: X Date of issue: xxx Out 30% >4 No 100 0.007 0.0002 In No >4 No 100 1.00 0.0227 Out 30% >4 No 100 0.70 0.0159 In No >4 No 100 1.00 0.0227 Out 30% >4 No 100 0.70 0.0159 In No >4 No 100 25.00 0.5672 In 90% >4 No 100 2.50 0.0567 Out 30% >4 No 100 17.50 0.3970 Out 30% >4 90% 100 1.75 0.0397 In No >4 No 100 25.00 0.5672 In 90% >4 No 100 2.50 0.0567 Out 30% >4 No 100 17.50 0.3970 Out 30% >4 90% 100 1.75 0.0397 In No >4 No 100 100.00 2.2686 In 95% >4 No 100 5.00 0.1134 Out 30% >4 No 100 70.00 1.5880 Out 30% >4 90% 100 7.00 0.1588 In No >4 No 100 25.00 0.5672 In 95% >4 No 100 1.25 0.0284 Out 30% >4 No 100 17.50 0.3970 Out 30% >4 90% 100 1.75 0.0397 In No >4 No 100 20.00 0.4537 In 90% >4 No 100 2.00 0.0454 Out 30% >4 No 100 14.00 0.3176 Out 30% >4 90% 100 1.40 0.0318 In No >4 No 100 10.00 0.2269 In 90% >4 No 100 1.00 0.0227 Out 30% >4 No 100 7.00 0.1588 In 4 to 8 100 5 0.1134 Out 4 to 8 100 0.5 0.0113 In No >4 No 100 10.00 0.2269 In 90% >4 No 100 1.00 0.0227 Out 30% >4 No 100 7.00 0.1588 In No >4 No 100 1.00 0.0227 Out 30% >4 No 100 0.70 0.0159 Version: XX NB. Please read the NOTICE on the front page Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled 0.0007 0.1 0.07 0.1 0.07 2.5 0.25 1.75 0.175 2.5 0.25 1.75 0.175 10 0.5 7 0.7 2.5 0.125 1.75 0.175 2 0.2 1.4 0.14 1 0.1 0.7 0.5 0.05 1 0.1 0.7 0.1 0.07 Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Page 27/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate 22b pt ≈ mp - Med Fugacity Out Date of issue: xxx No >4 No 100 3.00 0.0681 30% >4 No 100 2.10 0.0476 In No >4 No 100 10.00 0.2269 In 90% >4 No 100 1.00 0.0227 Out 30% >4 No 100 7.00 0.1588 In No >4 No 100 1.00 0.0227 Out 30% >4 No 100 0.70 0.0159 In No >4 No 100 3.00 0.0681 Out 30% >4 No 100 2.10 0.0476 In No >4 No 100 10.00 0.2269 In 90% >4 No 100 1.00 0.0227 Out 30% >4 No 100 7.00 0.1588 24a Low Fugacity In No >4 No 100 1.00 0.0227 Out 30% >4 No 100 0.70 0.0159 24b Med Fugacity In No >4 No 100 3.00 0.0681 Out 30% >4 No 100 2.10 0.0476 22c pt > mp - High Fugacity 23a pt<mp Low Fugacity 23b pt ≈ mp - Med Fugacity 23c pt > mp - High Fugacity 24c High Fugacity 26 In No >4 No 100 10.00 0.2269 In 80% >4 No 100 2.00 0.0454 Out 30% >4 No 100 7.00 0.1588 In No >4 No 100 10.00 0.2269 In 75% >4 No 100 2.50 0.0567 Out* 30% >4 No 100 7.00 0.1588 Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled RMMs required Risk controlled Risk controlled 0.3 0.21 1 0.1 0.7 0.1 0.07 0.3 0.21 1 0.1 0.7 0.1 0.07 0.3 0.21 1 0.2 0.7 1 0.25 0.7 *Outdoor exposure of industrial workers assumed to be reduced by 30% to give consistency with ECETOC calculations for solids. Workers (dermal) No systemic toxicity effects are expected due to the inorganic nature of the substance however local effects may occur but these effects will not be dose-dependent but will depend on the concentration of the substance present in the mixture/solution used in a specific application. Indirect exposure via the environment No indirect exposure of humans via the environment is expected for TKPP, as the substance can be effectively removed from the wastewater. Thus, no assessment of indirect exposure of humans via the environment is performed. Consumer exposure No direct consumer exposure is anticipated with the mixing of TKPP into final products. It is concluded that the mixing of TKPP into final products is of no risk for the general public. 5.2. Environmental exposure (qualitative assessment) Environmental release Revision date: X The use of TKPP can potentially result in aquatic emissions and locally increase the 3phosphate (PO4 ) concentration. Phosphates reaching surface water increase the phosphorus content in the water body which may cause eutrophication and water quality deterioration. Version: XX NB. Please read the NOTICE on the front page Page 28/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx Waste water treatment plants (WWTP) Phosphorus should be removed from industrial wastewater before it is released to the environment. This can be done by chemical treatment (by precipitation with the help of aluminium or iron addition) or biological treatments. A high degree of removal can be reliably achieved by the available phosphorus removal techniques. Site-specific conditions such as flow rate of the receiving surface water body and phosphorus concentration in the receiving surface water body should be taken into account when implementing an appropriate wastewater treatment. Council Directive 96/61/EC concerning integrated pollution prevention and control and national regulations concerning phosphates in industrial wastewater have to be followed to minimise the risk of eutrophication due to phosphate releases. Aquatic pelagic compartment No direct acute or long-term adverse effects on aqueous or terrestrial organisms are anticipated with orthophosphates in the environment. Sediments No direct acute or long-term adverse effects on aqueous or sediment organisms are anticipated with orthophosphates in the environment. Soil and groundwater No direct acute or long-term adverse effects on terrestrial organisms are anticipated with orthophosphates in the environment. Atmospheric compartment The formulation of TKPP is not considered to pose a risk to the atmospheric compartment. Secondary poisoning Bioaccumulation in organisms is not relevant for inorganic phosphates. ES3: Use as raw material, process aid and laboratory agent in chemical synthesis 1. Short title of exposure scenario 3 Use as raw material in chemical industry (synthesis), reactive processing aid and laboratory agent 2. Description of activities and processes covered in the exposure scenario Sector of use (SU) Product category (PC) Process category (PROC) Revision date: X SU 3: Industrial uses: uses of substances as such or in preparations at industrial sites SU 8: Manufacture of bulk, large scale chemicals (including petroleum products) SU 9: Manufacture of fine chemicals SU 12: Manufacture of plastics products, including compounding and conversion PC 19: Intermediate PC 20: Products such as ph-regulators, flocculants, precipitants, neutralisation agents PC 21: Laboratory chemicals PC 32: Polymer preparations and compounds PROC 1: Use in closed process, no likelihood of exposure PROC 2: Use in closed, continuous process with occasional controlled exposure PROC 3: Use in closed batch process (synthesis or formulation) PROC 4: Use in batch and other process (synthesis) where opportunity for exposure arises PROC 5: Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact) PROC 7: Industrial spraying PROC 8b: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities PROC 9: Transfer of substance or preparation into small containers (dedicated filling line, including weighing) PROC 14: Production of preparations or articles by tabletting, compression, extrusion, pelletisation PROC 15: Use as laboratory reagent PROC 19: Hand-mixing with intimate contact and only PPE available. Version: XX NB. Please read the NOTICE on the front page Page 29/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx PROC 26: Handling of solid inorganic substances at ambient temperature Article category (AC) Environmental release category (ERC) Not applicable ERC 1: Manufacture of substances ERC 2: Formulation of preparations ERC 3: Formulation in materials ERC 4: Industrial use of processing aids in processes and products, not becoming part of articles ERC 5: Industrial use resulting in inclusion into or onto a matrix ERC 6a: Industrial use resulting in manufacture of another substance (use of intermediates) ERC 6b: Industrial use of reactive processing aids ERC 6d: Industrial use of process regulators for polymerisation processes in production of resins, rubbers, polymers ERC 8a: Wide dispersive indoor use of processing aids in open systems ERC 8b: Wide dispersive indoor use of reactive substances in open systems ERC 8c: Wide dispersive indoor use resulting in inclusion into or onto a matrix 3. Operational conditions 3. 1 Operational conditions related with frequency and quantities of use Duration of exposure at workplace: Frequency of exposure at workplace: Annual amount used per site: TKPP may be used in chemical synthesis on 365 days a year for 24 hours a day divided into three working shifts. A single worker may be exposed on 220 days a year. No information about frequency and duration of the various tasks is available. In the first-tier assessment of exposure a frequency of once a day and an exposure duration of 8 hours will be considered. The daily and annual amount/emission per site is not considered to be the main determinant for environmental exposure. 3.2 Operational conditions related with substance/ product Physical state Solid / Liquid Concentration of substance in mixture A concentration of 100% w/w was used to assess exposure to the solid substance. The concentration of TKPP in solutions was set to > 25% w/w. 3.3 Other relevant operational conditions Not applicable. 4. Risk Management Measures 4.1 RMMs related to workers Organisational measures The employer must ensure that the required PPE is available and used according to instructions (provide training if necessary). PPE are required when breaching the system or handling the pure substance and concentrated solutions. Eye wash stations should be available in case of accidental contact. Technical measures Revision date: X Transport over pipes, technical barrel filling/emptying of barrel with automatic systems (suction pumps etc.) (Good practice) Use of pliers, grip arms with long handles with manual use “to avoid direct contact and exposure by splashes (no working over one’s head)” (Good practice) Store in cool, dry, clean, well ventilate areas. (Good practice). Local exhaust / general ventilation should be present when solids are handled to reduce the likelihood of inhalation exposure to dusts. Workers wear appropriate personal protective equipment, such as gloves, breathing masks and safety glasses when breaching the system or else being in contact with the Version: XX NB. Please read the NOTICE on the front page Page 30/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx undiluted substance. Respiratory protection Hand protection Eye protection Respiratory protection: Respiratory protection is required when workers are exposure to dusts, if LEV with an efficiency of ≥90% is not available. Exposure to dusts from the handling of solid materials should be reduced by the use of local exhaust ventilation (efficiency of at least 90%, please see below for specific requirements). NOTE. For certain processes an efficiency of ≥95% is assumed. Please see below exposure summary for details. If local exhaust ventilation is not available then it will be necessary to use personal respiratory protection that is compliant with EN141 or EN 405 and has a sufficient efficiency. Hand protection is recommended: impervious chemical resistant protective gloves. Material: Material of gloves: Butyl rubber, BR. Fluorocarbon rubber (Viton). Nitrile rubber, NBR. Natural rubber, NR. Chloroprene rubber, CR. Neoprene gloves. Workers handling concentrated TKPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. Goggles or face protection shield should be consistent with EN 166 or equivalent. Skin and body protection Wearing of suitable protective clothing and rubber boots is recommended. Hygiene measures Keep away from foodstuffs, drinks and tobacco. Wash hands before breaks and at end of work. Keep work clothes separate. 4.2 RMMs related to the environment Organisational measures Emissions to the environment must meet the requirements of Council Directive 96/61/EC and National Regulations concerning phosphate in industrial wastewater. Abatement measures related with wastewater The efficiency of the process is maximised in such a way that minimal emission of phosphates into the wastewater will occur. In addition, phosphate can be precipitated from the wastewater by addition of metal ions. Abatement measures waste air and solid waste Emissions of particles into the air of workplaces or the atmosphere can be significantly reduced by the use of cyclones, gas scrubbers or bag filters. Solid and liquid waste has to be incinerated or appropriately disposed of as chemical waste. 4.3 Waste related measures Type of waste Liquid waste, solid residues, packaging materials. Disposal technique The release of phosphates to wastewater is highly regulated. The residue of the containers or the used container itself should be disposed in accordance with local requirements. See Section 13 of the SDS for more information. Not determined. Fraction released to environment during waste treatment 5. Prediction of exposure and comparison of predicted exposure with DNELs (Risk Characterisation) 5.1. Human exposure Exposure estimation tool(s) ECETOC TRA (2010). MEASE(EBRC, Eurometaux, 2010): Used to assess exposure to inorganic solutions and handling of solid inorganics (PROC 26). Workers (oral) The use of TKPP in chemical synthesis will not notably contribute to the oral intake of phosphates. Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 31/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx It is also considered that workplace exposure limits for dust are applicable to this substance in the countries in which the substance is manufactured and used. Therefore, the exposure estimates will also be compared against a relevant general dust limit for an inhalable fraction of 10 mg/m3 as described by the occupational exposure limits detailed in the Technical Rules for Hazardous Materials – TRGS 900, January 2006 (Germany).This applies to both industrial and professional use as although the two settings are not directly comparable, it may be prudent to assess both the DNEL and the industrial against the same values both for consistency and for worker safety. A comparison of both the DNEL and a dust limit will ensure that downstream users have enough information on the required RMMs to ensure safe use in line with regional or national limits. A number of industrial activities associated with the mixing of TKPP into final products may result in inhalation exposure of workers to the substance. The risk characterisation ratios for these activities are given in the table below. Workers handling concentrated TKPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. The use of appropriate gloves and working suits is recommended. It is concluded that conditions can be defined under which the potential health risks from the use of TKPP in chemical synthesis are adequately controlled. Workers (inhalation) DNEL: Worker, longterm, systemic, inhalation: 3 44.08 mg/m General dust exposure limit: 10 mg/m3 Revision date: X Exposure scenario: Risk characterisation for use of TKPP as a raw material in chemical synthesis, as a process aid or as a laboratory reagent Activity type: Industrial Location: Indoors Airborne Weight TKPP fraction conc. RCR PRE (%) (mg/m3) (DNEL) Conclusion Activities performed with TKPP solutions Process Category LEV Duration (hours) 1 No >4 No > 25 0.001 0.00002 Risk controlled 0.0001 2 No >4 No > 25 0.001 0.00002 Risk controlled 0.0001 3 No >4 No > 25 0.01 0.00023 Risk controlled 0.001 4 No >4 No > 25 0.05 0.00113 Risk controlled 0.005 5 No >4 No > 25 0.05 0.00113 Risk controlled 0.005 No >4 No > 25 20.00 0.45372 Risk controlled 2 90% >4 No > 25 2.00 0.04537 Risk controlled 0.2 7 No >4 75% > 25 5.00 0.11343 Risk controlled 0.5 8b No >4 No > 25 0.01 0.00023 Risk controlled 0.001 9 No >4 No > 25 0.01 0.00023 Risk controlled 0.001 14 No >4 No > 25 0.01 0.00023 Risk controlled 0.001 15 No >4 No > 25 0.01 0.00023 Risk controlled 0.001 19 No >4 0.05 No > 25 0.00113 Risk controlled Activities performed with solids of low dustiness 0.005 1 No >4 No 100 0.01 0.0002 Risk controlled 0.001 2 No >4 No 100 0.01 0.0002 Risk controlled 0.001 Version: XX NB. Please read the NOTICE on the front page RCR (OEL) Conclusion Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Page 32/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx 3 No >4 No 100 0.10 0.0023 Risk controlled 0.01 4 No >4 No 100 0.50 0.0113 Risk controlled 0.05 5 No >4 No 100 0.50 0.0113 Risk controlled 0.05 7 No >4 No 100 1.00 0.0227 Risk controlled 0.1 8b No >4 No 100 0.10 0.0023 Risk controlled 0.01 9 No >4 No 100 0.10 0.0023 Risk controlled 0.01 14 No >4 No 100 0.10 0.0023 Risk controlled 0.01 15 No >4 No 100 0.10 0.0023 Risk controlled 0.01 19 No >4 No 100 0.50 0.0113 Risk controlled 0.05 26 No >4 1.50 Risk controlled No 100 0.0340 Activities performed with solids of medium dustiness 0.15 1 No >4 No 100 0.01 0.0002 Risk controlled 0.001 2 No >4 No 100 0.50 0.0113 Risk controlled 0.05 3 No >4 No 100 1.00 0.0227 Risk controlled 0.1 4 No >4 No 100 5.00 0.1134 Risk controlled 0.5 5 No >4 No 100 5.00 0.1134 Risk controlled 0.5 No >4 No 100 20.00 0.4537 Risk controlled 2 7 95% >4 No 100 1.00 0.0227 Risk controlled 0.1 8b No >4 No 100 5.00 0.1134 Risk controlled 0.5 No >4 No 100 5.00 0.1134 Risk controlled 0.5 No >4 No 100 1.00 0.0227 Risk controlled 0.1 15 No >4 No 100 0.50 0.0113 Risk controlled 0.05 19 No >4 No 100 5.00 0.1134 Risk controlled 0.5 26 No >4 4.00 Risk controlled No 100 0.0907 Activities performed with solids of high dustiness 0.4 1 No >4 No 100 0.01 0.0002 Risk controlled 0.001 2 No >4 No 100 1.00 0.0227 Risk controlled 0.1 3 No >4 No 100 1.00 0.0227 Risk controlled 0.1 No >4 No 100 25.00 0.5672 Risk controlled 2.5 90% >4 No 100 2.50 0.0567 Risk controlled 0.25 No >4 No 100 25.00 0.5672 Risk controlled 2.5 5 90% >4 No 100 2.50 0.0567 Risk controlled 0.25 7 No >4 No 100 100.00 2.2686 Risk controlled 10 9 14 4 Revision date: X Version: XX NB. Please read the NOTICE on the front page Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Page 33/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate 8b 9 Date of issue: xxx 95% >4 No 100 5.00 0.1134 Risk controlled 0.5 No >4 No 100 25.00 0.5672 Risk controlled 2.5 95% >4 No 100 1.25 0.0284 Risk controlled 0.125 No >4 No 100 20.00 0.4537 Risk controlled 2 90% >4 No 100 2.00 0.0454 Risk controlled 0.2 No >4 No 100 10.00 0.2269 Risk controlled 1 90% >4 No 100 1.00 0.0227 Risk controlled 0.1 No >4 No 100 5 0.1134 Risk controlled 0.5 No >4 No 100 25.00 0.5672 Risk controlled 2.5 90% >4 No 100 2.50 0.0567 Risk controlled 0.25 No >4 No 100 10.00 0.2269 Risk controlled 1 75% >4 No 100 2.50 0.0567 Risk controlled 0.25 14 15 19 26 Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Workers (dermal) No systemic toxicity effects are expected due to the inorganic nature of the substance however local effects may occur but these effects will not be dose-dependent but will depend on the concentration of the substance present in the mixture/solution used in a specific application. Workers are recommended to wear the appropriate PPE. Indirect exposure via the environment No indirect exposure of humans via the environment is expected for TKPP, as the substance can be effectively removed from the wastewater. Thus, no assessment of indirect exposure of humans via the environment is performed. Consumer exposure No direct consumer exposure is anticipated with the use of TKPP as a raw material and process aid in chemical synthesis. It is concluded that the use of TKPP as a raw material and process aid in chemical synthesis is of no risk for the general public. 5.2. Environmental exposure (qualitative assessment) Environmental release The use of TKPP can potentially result in aquatic emissions and locally increase the 3phosphate (PO4 ) concentration. Phosphates reaching surface water increase the phosphorus content in the water body which may cause eutrophication and water quality deterioration. Waste water treatment plants (WWTP) Phosphorus should be removed from industrial wastewater before it is released to the environment. This can be done by chemical treatment (by precipitation with the help of aluminium or iron addition) or biological treatments. A high degree of removal can be reliably achieved by the available phosphorus removal techniques. Site-specific conditions such as flow rate of the receiving surface water body and phosphorus concentration in the receiving surface water body should be taken into account when implementing an appropriate wastewater treatment. Council Directive 96/61/EC concerning integrated pollution prevention and control and national regulations concerning phosphates in industrial wastewater have to be followed to minimise the risk of eutrophication due to phosphate releases. Aquatic pelagic compartment No direct acute or long-term adverse effects on aqueous or terrestrial organisms are anticipated with orthophosphates in the environment. Sediments No direct acute or long-term adverse effects on aqueous or sediment organisms are Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 34/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx anticipated with orthophosphates in the environment. Soil and groundwater No direct acute or long-term adverse effects on terrestrial organisms are anticipated with orthophosphates in the environment. Atmospheric compartment The use of TKPP as a raw material and process aid in chemical synthesis is not considered to pose a risk to the atmospheric compartment. Secondary poisoning Bioaccumulation in organisms is not relevant for inorganic phosphates. ES4: Use of TKPP and products containing TKPP for treatment and finishing of metals 1. Short title of exposure scenario 4 Use of TKPP and products containing TKPP for treatment and finishing of metals 2. Description of activities and processes covered in the exposure scenario Sector of use (SU) SU 3: Industrial uses: uses of substances as such or in preparations at industrial sites Product category (PC) PC 14: Metal surface treatment products, including galvanic and electroplating products PC 25: Metal working fluids PC 33: Semiconductors Process category (PROC) PROC 1: Use in closed process, no likelihood of exposure PROC 2: Use in closed, continuous process with occasional controlled exposure PROC 3: Use in closed batch process (synthesis or formulation) PROC 4: Use in batch and other process (synthesis) where opportunity for exposure arises PROC 5: Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact) PROC 6: Calendaring operations PROC 7: Industrial spraying PROC 8a: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities PROC 8b: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities PROC 9: Transfer of substance or preparation into small containers (dedicated filling line, including weighing) PROC 10: Roller application or brushing PROC 11: Non industrial spraying PROC 12: Use of blowing agents in manufacture of foam PROC 13: Treatment of articles by dipping and pouring PROC 17: Lubrication at high energy conditions and in partly open process PROC 19: Hand-mixing with intimate contact and only PPE available. PROC 24: High (mechanical) energy work-up of substances bound in materials and/or articles Article category (AC) Not applicable Revision date: X SU 14: Manufacture of basic metals, including alloys SU 15: Manufacture of fabricated metal products, except machinery and equipment SU 16: Manufacture of computer, electronic and optical products, electrical equipment SU 17: General manufacturing, e.g. machinery, equipment, vehicles, other transport equipment SU 22: Professional uses Version: XX NB. Please read the NOTICE on the front page Page 35/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Environment al release category (ERC) Date of issue: xxx ERC 1: Manufacture of substances ERC 2: Formulation of preparations ERC 3: Formulation in materials ERC 4: Industrial use of processing aids in processes and products, not becoming part of articles ERC 5: Industrial use resulting in inclusion into or onto a matrix ERC 6a: Industrial use resulting in manufacture of another substance (use of intermediates) ERC 6b: Industrial use of reactive processing aids ERC 8a: Wide dispersive indoor use of processing aids in open systems ERC 8d: Wide dispersive outdoor use of processing aids in open systems ERC 8b: Wide dispersive indoor use of reactive substances in open systems ERC 8c: Wide dispersive indoor use resulting in inclusion into or onto a matrix ERC 8e: Wide dispersive outdoor use of reactive substances in open systems 3. Operational conditions 3. 1 Operational conditions related with frequency and quantities of use Duration of exposure at workplace: No information about frequency and duration of the various tasks is available. In the first-tier assessment of exposure a frequency of once a day and an exposure duration of 8 hours will be considered. Frequency of exposure at workplace: Annual amount used per site: The daily and annual amount/emission per site is not considered to be the main determinant for environmental exposure. 3.2 Operational conditions related with substance/ product Physical state Solid / Liquid Concentratio n of substance in mixture In the first-tier assessment of exposure the concentration of TKPP in solid form is set to 100% w/w; the concentration in the delivered solution is > 25% w/w. 3.3 Other relevant operational conditions Not applicable. 4. Risk Management Measures 4.1 RMMs related to workers Organisationa l measures The employer must ensure that the required PPE is available and used according to instructions (provide training if necessary). PPE are required when breaching the system or handling the pure substance and concentrated solutions. Eye wash stations should be available in case of accidental contact. Technical measures Revision date: X Transport over pipes, technical barrel filling/emptying of barrel with automatic systems (suction pumps etc.) (Good practice) Use of pliers, grip arms with long handles with manual use “to avoid direct contact and exposure by splashes (no working over one’s head)” (Good practice) Store in cool, dry, clean, well ventilate areas. (Good practice). Local exhaust / general ventilation should be present when solids are handled to reduce the likelihood of inhalation exposure to dusts. Breathing masks and local exhaust ventilation are present during industrial or nonindustrial spraying of solutions onto metal surfaces. Version: XX NB. Please read the NOTICE on the front page Page 36/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Respiratory protection Date of issue: xxx Respiratory protection: Respiratory protection is required when workers are exposure to dusts, if LEV with an efficiency of ≥90% is not available. Exposure to dusts from the handling of solid materials should be reduced by the use of local exhaust ventilation (efficiency of at least 90%, please see below for specific requirements). NOTE. For certain processes an efficiency of ≥95% is assumed. Please see below exposure summary for details It is assumed that professional locations may not have sufficient local exhaust ventilation, therefore , If local exhaust ventilation is not available then it will be necessary to use personal respiratory protection that is compliant with EN141 or EN 405 and has a sufficient efficiency (see table below for assumed APF and/or efficiency values). Hand protection Hand protection is recommended: impervious chemical resistant protective gloves. Material: Material of gloves: Butyl rubber, BR. Fluorocarbon rubber (Viton). Nitrile rubber, NBR. Natural rubber, NR. Chloroprene rubber, CR. Neoprene gloves. Eye protection Workers handling concentrated TKPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. Goggles or face protection shield should be consistent with EN 166 or equivalent. Eye protection is also recommended when workers are using metal parts treated with TKPP. Skin and body protection Wearing of suitable protective clothing and rubber boots is recommended. Hygiene measures Keep away from foodstuffs, drinks and tobacco. Wash hands before breaks and at end of work. Keep work clothes separate. 4.2 RMMs related to the environment Organisationa l measures Emissions to the environment must meet the requirements of Council Directive 96/61/EC and National Regulations concerning phosphate in industrial wastewater. Abatement measures related with wastewater The efficiency of the process is maximised in such a way that minimal emission of phosphates into the wastewater will occur. In addition, phosphate can be precipitated from the wastewater by addition of metal ions. Abatement measures waste air and solid waste Emissions of particles into the air of workplaces or the atmosphere can be significantly reduced by the use of cyclones, gas scrubbers or bag filters. Solid and liquid waste has to be incinerated or appropriately disposed of as chemical waste. 4.3 Waste related measures Type of waste Liquid waste, solid residues, packaging materials. Disposal technique The release of phosphates to wastewater is highly regulated. The residue of the containers or the used container itself should be disposed in accordance with local requirements. See Section 13 of the SDS for more information. Not determined. Fraction released to environment during waste treatment 5. Prediction of exposure and comparison of predicted exposure with DNELs (Risk Characterisation) 5.1. Human exposure Exposure estimation tool(s) Workers Revision date: X ECETOC TRA (2010). MEASE(EBRC, Eurometaux, 2010): Used to assess exposure to inorganic solutions and handling of solid inorganics (PROC 26). The use of TKPP in metal treatment and finishing will not notably contribute to the oral Version: XX NB. Please read the NOTICE on the front page Page 37/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate (oral) Date of issue: xxx intake of phosphates. It is also considered that workplace exposure limits for dust are applicable to this substance in the countries in which the substance is manufactured and used. Therefore, the exposure estimates will also be compared against a relevant general dust limit for an inhalable fraction of 10 mg/m3 as described by the occupational exposure limits detailed in the Technical Rules for Hazardous Materials – TRGS 900, January 2006 (Germany).This applies to both industrial and professional use as although the two settings are not directly comparable, it may be prudent to assess both the DNEL and the industrial against the same values both for consistency and for worker safety. A comparison of both the DNEL and a dust limit will ensure that downstream users have enough information on the required RMMs to ensure safe use in line with regional or national limits. INDUSTRIAL USERS: Various industrial activities associated with metal treatment and finishing may result in inhalation exposure of workers to TKPP. The risk characterisation ratios for these activities are given in the table below. Workers handling concentrated TKPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. The use of appropriate gloves and working suits is recommended. It is concluded that conditions can be defined under which the potential health risks from the use of TKPP in metal treatment and finishing are adequately controlled. Workers (inhalation) Table 1. DNEL: Worker, longterm, systemic, inhalation: 3 44.08 mg/m Exposure scenario: Risk characterisation for the industrial use of TKPP and products containing TKPP in metal treatment and finishing Location: Indoors Activity type: Industrial General dust exposure limit: 10 mg/m3 Process Category LEV Duratio n (hours) 1 No >4 No > 25 0.001 0.0000 2 2 No >4 No > 25 0.001 4 No >4 No > 25 5 No No 90 % 7 -Industrial spraying 8b Transfer of chemicals from/to vessels/ large containers at dedicated facilities 9 -Transfer of chemicals Revision date: X Airborn e TKPP Weight conc. PR fractio (mg/m3 RCR E n (%) ) (DNEL) Conclusion Activities performed with TKPP solutions >4 >4 No No > 25 > 25 > 25 RCR (OEL) Conclusio n Risk controlled 0.000 1 0.0000 2 Risk controlled 0.000 1 0.05 0.0011 3 Risk controlled 0.005 0.05 0.0011 3 Risk controlled 0.005 20.00 0.4537 2 Risk controlled 2 2.00 0.0453 7 Risk controlled 0.2 Risk controlled 0.5 Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled >4 No No >4 75 % > 25 5.00 0.1134 3 No >4 No > 25 0.01 0.0002 3 Risk controlled 0.001 Risk controlled No >4 No > 25 0.01 0.0002 3 Risk controlled 0.001 Risk controlled Version: XX NB. Please read the NOTICE on the front page Page 38/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate into small containers (dedicated filling line) 10 – Roller application or brushing 12 – Use of blowing agents in manufactur e of foam 13 – Treatment of articles by dipping and pouring 17 – Lubrication at high energy conditions and in partly open process 19 – Hand mixing with intimate contact and only PPE available Revision date: X Date of issue: xxx No >4 No > 25 0.05 0.0011 3 Risk controlled 0.005 Risk controlled No >4 No > 25 < 0.001 0.0000 2 Risk controlled 0.000 1 Risk controlled No >4 No > 25 0.01 0.0002 3 Risk controlled 0.001 Risk controlled No >4 No > 25 0.10 0.0022 7 Risk controlled 0.01 Risk controlled No >4 0.005 Risk controlled 1 No >4 No 100 0.01 0.0002 Risk controlled 0.001 2 No >4 No 100 0.01 0.0002 Risk controlled 0.001 4 No >4 No 100 0.50 0.0113 Risk controlled 0.05 5 No >4 No 100 0.50 0.0113 Risk controlled 0.05 6 No >4 No 100 0.10 0.0023 Risk controlled 0.01 7 No >4 No 100 1.00 0.0227 Risk controlled 0.1 8b No >4 No 100 0.10 0.0023 Risk controlled 0.01 9 No >4 No 100 0.10 0.0023 Risk controlled 0.01 10 No >4 No 100 0.50 0.0113 Risk controlled 0.05 13 No >4 No 100 0.10 0.0023 Risk controlled 0.01 17 No >4 No 100 1.00 0.0227 Risk controlled 0.1 19 24a Low Fugacity 24b Med Fugacity No >4 No 100 0.50 0.0113 Risk controlled 0.05 Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled No >4 No 100 1.00 0.0227 Risk controlled 0.1 Risk controlled No >4 No 100 3.00 0.0681 Risk controlled 0.3 24c High Fugacity No 80 % >4 No 100 10.00 0.2269 Risk controlled 1 1 No >4 No 100 0.01 0.0002 Risk controlled 0.001 2 No >4 No 100 0.50 0.0113 Risk controlled 0.05 4 5 No No >4 >4 No No 100 100 5.00 5.00 0.1134 0.1134 Risk controlled Risk controlled 0.5 0.5 >4 0.0011 0.05 Risk controlled No > 25 3 Activities performed with solids of low dustiness No 100 2.00 0.0454 Risk controlled Activities performed with solids of medium dustiness Version: XX NB. Please read the NOTICE on the front page 0.2 Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk Page 39/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx No >4 No 100 5.00 0.1134 Risk controlled 0.5 No 95 % >4 No 100 20.00 0.4537 Risk controlled 2 >4 No 100 1.00 0.0227 Risk controlled 0.1 8b No >4 No 100 5.00 0.1134 Risk controlled 0.5 9 No >4 No 100 5.00 0.1134 Risk controlled 0.5 10 No >4 No 100 5.00 0.1134 Risk controlled 0.5 13 No >4 No 100 1.00 0.0227 Risk controlled 0.1 >4 No 100 20.00 0.4537 Risk controlled 2 17 No 95 % >4 No 100 1.00 0.0227 Risk controlled 0.1 19 24a Low Fugacity 24b Med Fugacity No >4 No 100 5.00 0.1134 Risk controlled 0.5 controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled No >4 No 100 3.00 0.0681 Risk controlled 0.3 Risk controlled No >4 No 100 3.00 0.0681 Risk controlled 0.3 24c High Fugacity No 80 % >4 No 100 10.00 0.2269 Risk controlled 1 1 No >4 No 100 0.01 0.0002 Risk controlled 0.001 2 No >4 No 100 1.00 0.0227 Risk controlled 0.1 >4 No 100 25.00 0.5672 Risk controlled 2.5 4 No 90 % >4 No 100 2.50 0.0567 Risk controlled 0.25 >4 No 100 25.00 0.5672 Risk controlled 2.5 >4 >4 No No 100 100 2.50 25.00 0.0567 0.5672 Risk controlled Risk controlled 0.25 2.5 6 No 90 % No 90 % >4 No 100 2.50 0.0567 0.25 >4 No 100 100.00 2.2686 7 No 95 % Risk controlled RMMs required >4 No 100 5.00 0.1134 Risk controlled 0.5 >4 No 100 25.00 0.5672 Risk controlled 2.5 8b No 95 % >4 No 100 1.25 0.0284 Risk controlled 0.125 >4 No 100 20.00 0.4537 Risk controlled 2 9 No 90 % >4 No 100 2.00 0.0454 Risk controlled 0.2 No 90 % >4 No 100 10.00 0.2269 Risk controlled 1 >4 No 100 1.00 0.0227 Risk controlled 0.1 No >4 No 100 5.00 0.1134 Risk controlled 0.5 No 95 % No >4 No 100 50.00 1.1343 Risk controlled 5 >4 >4 No No 100 100 2.50 25.00 0.0567 0.5672 Risk controlled Risk controlled 0.25 2.5 6 7 5 10 13 17 19 Revision date: X >4 No 100 2.00 0.0454 Risk controlled Activities performed with solids of high dustiness Version: XX NB. Please read the NOTICE on the front page 0.2 10 Risk controlled RMMs required Risk controlled Risk controlled Risk controlled RMMs required Risk controlled RMMs required Risk controlled Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled Risk controlled RMMs required Risk controlled RMMs Page 40/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate 24a Low Fugacity 24b Med Fugacity 24c High Fugacity Date of issue: xxx 90 % >4 No 100 2.50 0.0567 Risk controlled 0.25 required Risk controlled No >4 No 100 1.00 0.0227 Risk controlled 0.1 Risk controlled No >4 No 100 3.00 0.0681 Risk controlled 0.3 No 80 % >4 No 100 10.00 0.2269 Risk controlled 1 >4 No 100 2.00 0.0454 Risk controlled 0.2 Risk controlled RMMs required Risk controlled *Outdoor exposure of industrial workers assumed to be reduced by 30% to give consistency with ECETOC calculations for solids. PROFESSIONAL USERS: Various professional activities associated with metal treatment and finishing may result in inhalation exposure to TKPP of workers. The risk characterisation ratios for these activities are given in the table below. Workers handling concentrated TKPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. The use of appropriate gloves and working suits is recommended. It is concluded that conditions can be defined under which the potential health risks from the use of TKPP in professional metal treatment and finishing are adequately controlled. Table 2. Exposure scenario: Risk characterisation for the professional use of TKPP and products containing TKPP in metal treatment and finishing Location: Indoors (Ind / Outdoors (Out) Activity type: Professional No >4 Out 30% >4 In No >4 Out 30% >4 In No >4 Out 30% >4 In No >4 In 80% >4 Version: XX NB. Please read the NOTICE on the front page Conclusion In RCR (OEL) >4 Conclusion 30% RCR (DNEL) Out Airborne TKPP conc. (mg/m3) Revision date: X >4 Weight fraction (%) 11 No PRE 10 Duration (hours) 8a LEV 5 Location Process Category 4 In Activities performed with TKPP solutions Risk No > 25 0.10 0.0023 controlled Risk No > 25 0.071 0.0016 controlled Risk No > 25 0.10 0.0023 controlled Risk No > 25 0.071 0.0016 controlled Risk No > 25 0.05 0.0011 controlled Risk No > 25 0.036 0.0008 controlled Risk No > 25 0.05 0.0011 controlled Risk No > 25 0.036 0.0008 controlled Risk No > 25 20.00 0.4537 controlled Risk No > 25 4.00 0.0907 controlled 0.01 Risk controlled 0.0071 Risk controlled 0.01 Risk controlled 0.0071 Risk controlled 0.005 Risk controlled 0.0036 Risk controlled 0.005 Risk controlled 0.0036 Risk controlled 2 RMMs required 0.4 Risk controlled Page 41/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Out 30% Out 30% In No Out 30% In No Out 30% In No Out 30% In No 5 Out 30% 6 In No In No Out 30% In No Out 30% In No Out 30% In No Out 30% In No Out 30% In No Out 30% In No 5 Out 30% 6 In No In No Out 30% In No Out 30% In No In 80% In No 13 19 4 8a 10 11 13 19 4 8a 10 11 Revision date: X Date of issue: xxx Risk controlled Risk >4 75% > 25 3.56 0.0808 controlled Risk >4 No > 25 0.05 0.0011 controlled Risk >4 No > 25 0.036 0.0008 controlled Risk >4 No > 25 0.05 0.0011 controlled Risk >4 No > 25 0.05 0.0011 controlled Activities performed with solids of low dustiness Risk 1.00 >4 No 100 0.0227 controlled Risk >4 No 100 0.70 0.0159 controlled Risk 1.00 >4 No 100 0.0227 controlled Risk >4 No 100 0.70 0.0159 controlled Risk >4 No 100 0.1 0.0023 controlled Risk 0.50 >4 No 100 0.0113 controlled Risk >4 No 100 0.35 0.0079 controlled Risk 0.50 >4 No 100 0.0113 controlled Risk >4 No 100 0.35 0.0079 controlled Risk 1.00 >4 No 100 0.0227 controlled Risk >4 No 100 0.70 0.0159 controlled Risk 0.50 >4 No 100 0.0113 controlled Risk >4 No 100 0.35 0.0079 controlled Risk 0.50 >4 No 100 0.0113 controlled Risk >4 No 100 0.35 0.0079 controlled Activities performed with solids of medium dustiness Risk 5.00 >4 No 100 0.1134 controlled Risk >4 No 100 3.50 0.0794 controlled Risk 5.00 >4 No 100 0.1134 controlled Risk >4 No 100 3.50 0.0794 controlled Risk >4 No 100 5.00 0.1134 controlled Risk 5.00 >4 No 100 0.1134 controlled Risk >4 No 100 3.50 0.0794 controlled Risk 5.00 >4 No 100 0.1134 controlled Risk >4 No 100 3.50 0.0794 controlled Risk 20.00 >4 No 100 0.4537 controlled Risk >4 No 100 4.00 0.0907 controlled Risk >4 90% 100 2.00 0.0454 controlled >4 No > 25 Version: XX NB. Please read the NOTICE on the front page 14.25 0.3233 1.425 Risk controlled 0.356 Risk controlled 0.005 Risk controlled 0.0036 Risk controlled 0.005 Risk controlled 0.005 Risk controlled 0.1 Risk controlled 0.07 Risk controlled 0.1 Risk controlled 0.07 Risk controlled 0.01 Risk controlled 0.05 Risk controlled 0.035 Risk controlled 0.05 Risk controlled 0.035 Risk controlled 0.1 Risk controlled 0.07 Risk controlled 0.05 Risk controlled 0.035 Risk controlled 0.05 Risk controlled 0.035 Risk controlled 0.5 Risk controlled 0.35 Risk controlled 0.5 Risk controlled 0.35 Risk controlled 0.5 Risk controlled 0.5 Risk controlled 0.35 Risk controlled 0.5 Risk controlled 0.35 Risk controlled 2 RMMs required 0.4 Risk controlled 0.2 Risk controlled Page 42/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate 13 19 4 5 8a 10 11 Revision date: X Out 30% Out 30% In No Out 30% In No Out 30% In No In 80% In 80% In No Out 30% Out 30% In No In 80% In 80% In No Out 30% Out 30% In No In 80% In 80% In No Out 30% Out 30% In No In 80% In No Out 30% In No In 80% In 80% In No In No In 80% Out 30% Out 30% Date of issue: xxx Risk controlled Risk >4 90% 100 1.40 0.0318 controlled Risk 5.00 >4 No 100 0.1134 controlled Risk >4 No 100 3.50 0.0794 controlled Risk 5.00 >4 No 100 0.1134 controlled Risk >4 No 100 3.50 0.0794 controlled Activities performed with solids of high dustiness RMMs 50.00 >4 No 100 1.1343 required Risk >4 No 100 10.00 0.2269 controlled Risk 1 to 4 No 100 6.00 0.1361 controlled Risk >4 90% 100 5.00 0.1134 controlled Risk >4 No 100 35.00 0.7940 controlled Risk >4 90% 100 3.50 0.0794 controlled RMMs 50.00 >4 No 100 1.1343 required Risk >4 No 100 10.00 0.2269 controlled Risk 1 to 4 No 100 6.00 0.1361 controlled Risk >4 90% 100 5.00 0.1134 controlled Risk >4 No 100 35.00 0.7940 controlled Risk >4 90% 100 3.50 0.0794 controlled RMMs 50.00 >4 No 100 1.1343 required Risk >4 No 100 10.00 0.2269 controlled Risk 1 to 4 No 100 6.00 0.1361 controlled Risk >4 90% 100 5.00 0.1134 controlled Risk >4 No 100 35.00 0.7940 controlled Risk >4 90% 100 3.50 0.0794 controlled Risk 10.00 >4 No 100 0.2269 controlled Risk >4 No 100 2.00 0.0454 controlled Risk >4 90% 100 1.00 0.0227 controlled Risk >4 No 100 7.00 0.1588 controlled RMMs 200.00 4.5372 required >4 No 100 Risk >4 No 100 40.00 0.9074 controlled Risk 0.25 to 1 No 100 8.00 0.1815 controlled Risk >4 90% 100 20.00 0.4537 controlled Risk 0.25 to 1 90% 100 4.00 0.0907 controlled Risk >4 90% 100 4.00 0.0907 controlled RMMs >4 No 100 140.00 3.1760 required Risk >4 95% 100 7.00 0.1588 controlled >4 No 100 Version: XX NB. Please read the NOTICE on the front page 14.00 0.3176 1.4 RMMs required 0.14 Risk controlled 0.5 Risk controlled 0.35 Risk controlled 0.5 Risk controlled 0.35 Risk controlled 5 RMMs required 1 RMMs required 0.6 Risk controlled 0.5 Risk controlled 3.5 Risk controlled 0.35 Risk controlled 5 RMMs required 1 RMMs required 0.6 Risk controlled 0.5 Risk controlled 3.5 Risk controlled 0.35 Risk controlled 5 RMMs required 1 RMMs required 0.6 Risk controlled 0.5 Risk controlled 3.5 RMMs required 0.35 Risk controlled 1 RMMs required 0.2 Risk controlled 0.1 Risk controlled 0.7 Risk controlled 20 RMMs required 4 RMMs required 0.8 Risk controlled 2 RMMs required 0.4 Risk controlled 0.4 Risk controlled 14 RMMs required 0.7 Risk controlled Page 43/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate 13 19 Date of issue: xxx In No >4 No 100 5.00 0.1134 Out 30% >4 No 100 3.50 0.0794 In No >4 No 100 50.00 1.1343 In 80% >4 No 100 10.00 0.2269 In 80% 1 to 4 No 100 3.00 0.0681 In No >4 90% 100 5.00 0.1134 Out 30% >4 No 100 35.00 0.7940 Out 30% >4 90% 100 3.50 0.0794 Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled 0.5 Risk controlled 0.35 Risk controlled 5 RMMs required 1 RMMs required 0.3 Risk controlled 0.5 Risk controlled 3.5 RMMs required 0.35 Risk controlled Workers (dermal) No systemic toxicity effects are expected due to the inorganic nature of the substance however local effects may occur but these effects will not be dose-dependent but will depend on the concentration of the substance present in the mixture/solution used in a specific application. Indirect exposure via the environment No indirect exposure of humans via the environment is expected for TKPP, as the substance can be effectively removed from the wastewater. Thus, no assessment of indirect exposure of humans via the environment is performed. Consumer exposure No direct consumer exposure is anticipated with the use of TKPP in metal treatment and finishing. It is concluded that the use of TKPP in metal treatment and finishing is of no risk for the general public. 5.2. Environmental exposure (qualitative assessment) Environmenta l release The use of TKPP can potentially result in aquatic emissions and locally increase the 3phosphate (PO4 ) concentration. Phosphates reaching surface water increase the phosphorus content in the water body which may cause eutrophication and water quality deterioration. Waste water treatment plants (WWTP) Phosphorus should be removed from industrial wastewater before it is released to the environment. This can be done by chemical treatment (by precipitation with the help of aluminium or iron addition) or biological treatments. A high degree of removal can be reliably achieved by the available phosphorus removal techniques. Site-specific conditions such as flow rate of the receiving surface water body and phosphorus concentration in the receiving surface water body should be taken into account when implementing an appropriate wastewater treatment. Council Directive 96/61/EC concerning integrated pollution prevention and control and national regulations concerning phosphates in industrial wastewater have to be followed to minimise the risk of eutrophication due to phosphate releases. Aquatic pelagic compartment No direct acute or long-term adverse effects on aqueous or terrestrial organisms are anticipated with orthophosphates in the environment. Sediments No direct acute or long-term adverse effects on aqueous or sediment organisms are anticipated with orthophosphates in the environment. Soil and groundwater No direct acute or long-term adverse effects on terrestrial organisms are anticipated with orthophosphates in the environment. Atmospheric compartment The use of TKPP and products containing TKPP for the treatment of metals is not considered to pose a risk to the atmospheric compartment. Secondary poisoning Bioaccumulation in organisms is not relevant for inorganic phosphates. Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 44/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx ES5: Leather and textiles manufacturing and treatment with products containing TKPP 1. Short title of exposure scenario 5 Leather and textiles manufacturing and treatment with products containing TKPP 2. Description of activities and processes covered in the exposure scenario Sector of use (SU) Product category (PC) Process category (PROC) Article category (AC) Environmental release category (ERC) SU 3: Industrial uses: uses of substances as such or in preparations at industrial sites SU 5: Manufacture of textiles, leather, fur PC 23: Leather tanning, dye, finishing and impregnation and care products PC 34: Textile dyes, finishing and impregnating products; including bleaches and other processing aids PROC 2: Use in closed, continuous process with occasional controlled exposure PROC 3: Use in closed batch process (synthesis or formulation) PROC 4: Use in batch and other process (synthesis) where opportunity for exposure arises PROC 5: Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact) PROC 6: Calendaring operations PROC 7: Industrial spraying PROC 8b: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities PROC 9: Transfer of substance or preparation into small containers (dedicated filling line, including weighing) PROC 10: Roller application or brushing PROC 13: Treatment of articles by dipping and pouring PROC 19: Hand-mixing with intimate contact and only PPE available. PROC 26: Handling of solid inorganic substances at ambient temperature Not applicable ERC 4: Industrial use of processing aids in processes and products, not becoming part of articles ERC 5: Industrial use resulting in inclusion into or onto a matrix ERC 6b: Industrial use of reactive processing aids ERC 8a: Wide dispersive indoor use of processing aids in open systems ERC 11a: Wide dispersive indoor use of long-life articles and materials with low release 3. Operational conditions 3. 1 Operational conditions related with frequency and quantities of use Duration of exposure at workplace: No information about frequency and duration of the various tasks is available. In the first-tier assessment of exposure a frequency of once a day and an exposure duration of 8 hours was considered. A single worker may be exposed on 220 days per year. Frequency of exposure at workplace: Annual amount used per site: The daily and annual amount/emission per site is not considered to be the main determinant for environmental exposure. 3.2 Operational conditions related with substance/ product Physical state Revision date: X Solid / Liquid Version: XX NB. Please read the NOTICE on the front page Page 45/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Concentration of substance in mixture Date of issue: xxx No information about the concentration of the substance in solid products and dilute solutions is available. In the first-tier assessment of exposure the concentration of TKPP in the solid preparations will be set to 100% w/w. The concentration in the undiluted solution is set to > 25 % w/w. 3.3 Other relevant operational conditions Not applicable. 4. Risk Management Measures 4.1 RMMs related to workers Organisational measures The employer must ensure that the required PPE is available and used according to instructions (provide training if necessary). PPE are required when breaching the system or handling the pure substance and concentrated solutions. Eye wash stations should be available in case of accidental contact. Technical measures Respiratory protection Transport over pipes, technical barrel filling/emptying of barrel with automatic systems (suction pumps etc.) (Good practice) Use of pliers, grip arms with long handles with manual use “to avoid direct contact and exposure by splashes (no working over one’s head)” (Good practice) Store in cool, dry, clean, well ventilate areas. (Good practice). Local exhaust ventilation may be present. Workers wear appropriate personal protection equipment, such as gloves, working suits and safety glasses, when handling the TKPP in solid form or as solutions. Respiratory protection: Respiratory protection is required when workers are exposure to dusts, if LEV with an efficiency of ≥90% is not available. Exposure to dusts from the handling of solid materials should be reduced by the use of local exhaust ventilation (efficiency of at least 90%, please see below for specific requirements). NOTE. For certain processes an efficiency of ≥95% is assumed. Please see below exposure summary for details It is assumed that professional locations may not have sufficient local exhaust ventilation, therefore , If local exhaust ventilation is not available then it will be necessary to use personal respiratory protection that is compliant with EN141 or EN 405 and has a sufficient efficiency (see table below for assumed APF and/or efficiency values). Hand protection Hand protection is recommended: impervious chemical resistant protective gloves. Material: Material of gloves: Butyl rubber, BR. Fluorocarbon rubber (Viton). Nitrile rubber, NBR. Natural rubber, NR. Chloroprene rubber, CR. Neoprene gloves. Eye protection Workers handling concentrated TKPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. Goggles or face protection shield should be consistent with EN 166 or equivalent. Skin and body protection Wearing of suitable protective clothing and rubber boots is recommended. Hygiene measures Keep away from foodstuffs, drinks and tobacco. Wash hands before breaks and at end of work. Keep work clothes separate. 4.2 RMMs related to the environment Organisational measures Emissions to the environment must meet the requirements of Council Directive 96/61/EC and National Regulations concerning phosphate in industrial wastewater. Abatement measures related with wastewater The efficiency of the process is maximised in such a way that minimal emission of phosphates into the wastewater will occur. In addition, phosphate can be precipitated from the wastewater by addition of metal ions. Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 46/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Abatement measures waste air and solid waste Date of issue: xxx Emissions of particles into the air of workplaces or the atmosphere can be significantly reduced by the use of cyclones, gas scrubbers or bag filters. Solid and liquid waste has to be incinerated or appropriately disposed of as chemical waste. 4.3 Waste related measures Type of waste Liquid waste, solid residues, packaging materials. Disposal technique The release of phosphates to wastewater is highly regulated. The residue of the containers or the used container itself should be disposed in accordance with local requirements. See Section 13 of the SDS for more information. Not determined. Fraction released to environment during waste treatment 5. Prediction of exposure and comparison of predicted exposure with DNELs (Risk Characterisation) 5.1. Human exposure Exposure estimation tool(s) Workers (oral) Workers (inhalation) ECETOC TRA (2010). MEASE(EBRC, Eurometaux, 2010): Used to assess exposure to inorganic solutions and handling of solid inorganics (PROC 26). The use of TKPP in manufacturing and treatment of leather and textiles will not notably contribute to the oral intake of phosphates. It is also considered that workplace exposure limits for dust are applicable to this substance in the countries in which the substance is manufactured and used. Therefore, the exposure estimates will also be compared against a relevant general dust limit for an inhalable fraction of 10 mg/m3 as described by the occupational exposure limits detailed in the Technical Rules for Hazardous Materials – TRGS 900, January 2006 (Germany).This applies to both industrial and professional use as although the two settings are not directly comparable, it may be prudent to assess both the DNEL and the industrial against the same values both for consistency and for worker safety. A comparison of both the DNEL and a dust limit will ensure that downstream users have enough information on the required RMMs to ensure safe use in line with regional or national limits. DNEL: Worker, longterm, systemic, inhalation: 3 44.08 mg/m Various industrial activities associated with manufacturing and treatment of leather and textiles may result in inhalation exposure of workers to TKPP. The risk characterisation ratios for these activities are given in the table below. Workers handling concentrated TKPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. The use of appropriate gloves and working suits is recommended. It is concluded that conditions can be defined under which the potential health risks from the use of TKPP in leather and textiles manufacture and treatment are adequately controlled. General dust exposure limit: 10 mg/m3 Exposure scenario: Risk characterisation for the industrial use of TKPP in leather and textile manufacturing and treatment Location: Indoors Activity type: Industrial Revision date: X Airborne Weight TKPP fraction conc. RCR PRE (%) (mg/m3) (DNEL) Conclusion Activities performed with TKPP solutions Process Category LEV Duration (hours) 2 No >4 No > 25 0.001 0.00002 Risk controlled 0.0001 3 No >4 No > 25 0.01 0.00023 Risk controlled 0.001 4 No >4 No > 25 0.05 0.00113 Risk controlled 0.005 Version: XX NB. Please read the NOTICE on the front page RCR (OEL) Conclusion Risk controlled Risk controlled Risk controlled Page 47/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx >4 No > 25 0.05 0.00113 Risk controlled 0.005 No >4 No > 25 20.00 0.45372 Risk controlled 2 90% >4 No > 25 2.00 0.04537 Risk controlled 0.2 7 No >4 75% > 25 5.00 0.11343 Risk controlled 0.5 8b No >4 No > 25 0.01 0.00023 Risk controlled 0.001 9 No >4 No > 25 0.01 0.00023 Risk controlled 0.001 10 No >4 No > 25 0.05 0.00113 Risk controlled 0.005 13 No >4 No > 25 0.01 0.00023 Risk controlled 0.001 19 No >4 0.05 No > 25 0.00113 Risk controlled Activities performed with solids of low dustiness 0.005 2 No >4 No 100 0.01 0.0002 Risk controlled 0.001 3 No >4 No 100 0.10 0.0023 Risk controlled 0.01 4 No >4 No 100 0.50 0.0113 Risk controlled 0.05 5 No >4 No 100 0.50 0.0113 Risk controlled 0.05 6 No >4 No 100 0.10 0.0023 Risk controlled 0.01 7 No >4 No 100 1.00 0.0227 Risk controlled 0.1 8b No >4 No 100 0.10 0.0023 Risk controlled 0.01 9 No >4 No 100 0.10 0.0023 Risk controlled 0.01 10 No >4 No 100 0.50 0.0113 Risk controlled 0.05 13 No >4 No 100 0.10 0.0023 Risk controlled 0.01 19 No >4 No 100 0.50 0.0113 Risk controlled 0.05 26 No >4 1.50 RMMs required No 100 0.0340 Activities performed with solids of medium dustiness 0.15 2 No >4 No 100 0.50 0.0113 Risk controlled 0.05 3 No >4 No 100 1.00 0.0227 Risk controlled 0.1 4 No >4 No 100 5.00 0.1134 Risk controlled 0.5 5 6 No >4 No 100 5.00 0.1134 Risk controlled 0.5 No >4 No 100 5.00 0.1134 Risk controlled 0.5 No >4 No 100 20.00 0.4537 Risk controlled 2 95% >4 No 100 1.00 0.0227 Risk controlled 0.1 8b No >4 No 100 5.00 0.1134 Risk controlled 0.5 9 No >4 No 100 5.00 0.1134 Risk controlled 0.5 10 No >4 No 100 5.00 0.1134 Risk controlled 0.5 13 No >4 No 100 1.00 0.0227 Risk controlled 0.1 19 No >4 No 100 5.00 0.1134 Risk controlled 0.5 26 No >4 4.00 No 100 0.0907 Risk controlled Activities performed with solids of high dustiness 0.4 Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled 2 No >4 0.1 Risk controlled 7 Revision date: X Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled No 5 No 100 1.00 Version: XX NB. Please read the NOTICE on the front page 0.0227 Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Page 48/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx No >4 No 100 1.00 0.0227 Risk controlled 0.1 No >4 No 100 25.00 0.5672 Risk controlled 2.5 90% >4 No 100 2.50 0.0567 Risk controlled 0.25 No >4 No 100 25.00 0.5672 Risk controlled 2.5 90% >4 No 100 2.50 0.0567 Risk controlled 0.25 No >4 No 100 25.00 0.5672 Risk controlled 2.5 90% >4 No 100 2.50 0.0567 Risk controlled 0.25 No >4 No 100 100.00 2.2686 RMMs required 10 95% >4 No 100 5.00 0.1134 Risk controlled 0.5 No >4 No 100 25.00 0.5672 Risk controlled 2.5 95% >4 No 100 1.25 0.0284 Risk controlled 0.125 No >4 No 100 20.00 0.4537 Risk controlled 2 90% >4 No 100 2.00 0.0454 Risk controlled 0.2 No >4 No 100 10.00 0.2269 Risk controlled 1 10 90% >4 No 100 1.00 0.0227 Risk controlled 0.1 13 No >4 No 100 5.00 0.1134 Risk controlled 0.5 No >4 No 100 25.00 0.5672 Risk controlled 2.5 90% >4 No 100 2.50 0.0567 Risk controlled 0.25 No >4 No 100 10.00 0.2269 Risk controlled 1 75% >4 No 100 2.50 0.0567 Risk controlled 0.25 3 4 5 6 7 8b 9 19 26 Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled Risk controlled RMMs required Risk controlled RMMs required Risk controlled Workers (dermal) No systemic toxicity effects are expected due to the inorganic nature of the substance however local effects may occur but these effects will not be dose-dependent but will depend on the concentration of the substance present in the mixture/solution used in a specific application. Indirect exposure via the environment No indirect exposure of humans via the environment is expected for TKPP, as the substance can be effectively removed from the wastewater. Thus, no assessment of indirect exposure of humans via the environment is performed. Consumer exposure No direct consumer exposure is anticipated with leather and textile manufacture and treatment. It is concluded that the use of TKPP in leather and textile manufacture and treatment is of no risk for the general public. 5.2. Environmental exposure (qualitative assessment) Environmental release The use of TKPP can potentially result in aquatic emissions and locally increase the 3phosphate (PO4 ) concentration. Phosphates reaching surface water increase the phosphorus content in the water body which may cause eutrophication and water quality deterioration. Waste water treatment plants Phosphorus should be removed from industrial wastewater before it is released to the environment. This can be done by chemical treatment (by precipitation with the help of aluminium or iron addition) or biological treatments. A high degree of removal can be Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 49/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx (WWTP) reliably achieved by the available phosphorus removal techniques. Site-specific conditions such as flow rate of the receiving surface water body and phosphorus concentration in the receiving surface water body should be taken into account when implementing an appropriate wastewater treatment. Council Directive 96/61/EC concerning integrated pollution prevention and control and national regulations concerning phosphates in industrial wastewater have to be followed to minimise the risk of eutrophication due to phosphate releases. Aquatic pelagic compartment No direct acute or long-term adverse effects on aqueous or terrestrial organisms are anticipated with orthophosphates in the environment. Sediments Soil and groundwater No direct acute or long-term adverse effects on aqueous or sediment organisms are anticipated with orthophosphates in the environment. No direct acute or long-term adverse effects on terrestrial organisms are anticipated with orthophosphates in the environment. Atmospheric compartment The use of TKPP and products containing TKPP for the manufacture and treatment of leather and textiles is not considered to pose a risk to the atmospheric compartment. Secondary poisoning Bioaccumulation in organisms is not relevant for inorganic phosphates. Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 50/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx ES6: Use of TKPP and products containing TKPP for water and wastewater treatment 1. Short title of exposure scenario 6 Use of TKPP and products containing TKPP for water and wastewater treatment 2. Description of activities and processes covered in the exposure scenario Sector of use (SU) Product category (PC) Process category (PROC) Article category (AC) Environmental release category (ERC) SU 3: Industrial uses: uses of substances as such or in preparations at industrial sites SU 22: Professional uses. SU 23: Electricity, steam, gas water supply and sewage treatment PC 16: Heat transfer fluids PC 20: Products such as ph-regulators, flocculants, precipitants, neutralisation agents PC 36: Water softeners PC 37: Water treatment chemicals PROC 1: Use in closed process, no likelihood of exposure PROC 2: Use in closed, continuous process with occasional controlled exposure PROC 6: Calendaring operations PROC 7: Industrial spraying PROC 8a: Transfer of chemicals from/to vessels/ large containers at non dedicated facilities PROC 8b: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities PROC 9: Transfer of substance or preparation into small containers (dedicated filling line, including weighing) PROC 11: Non-industrial spraying PROC 14: Production of preparations or articles by tabletting, compression, extrusion, pelletisation PROC 19: Hand-mixing with intimate contact and only PPE available. PROC 22: Potentially closed processing operations with minerals/metals at elevated temperature. Industrial setting. PROC 26: Handling of solid inorganic substances at ambient temperature Not applicable ERC 1: Manufacture of substances ERC 2: Formulation of preparations ERC 3: Formulation in materialsERC 4: Industrial use of processing aids in processes and products, not becoming part of articles ERC 5: Industrial use resulting in inclusion into or onto a matrix ERC 6a: Industrial use resulting in manufacture of another substance (use of intermediates) ERC 6b: Industrial use of reactive processing aids ERC 7: Industrial use of substances in closed systems ERC 8a: Wide dispersive indoor use of processing aids in open systems ERC 8b: Wide dispersive indoor use of reactive substances in open systems ERC 8d: Wide dispersive outdoor use of processing aids in open systems ERC 8e: Wide dispersive outdoor use of reactive substances in open systems ERC 8f: Wide dispersive outdoor use resulting in inclusion into or onto a matrix ERC 9a: Wide dispersive indoor use of substances in closed systems ERC 9b: wide dispersive outdoor use of substances in closed systems ERC 11a: Wide dispersive indoor use of long-life articles and materials with low release 3. Operational conditions 3. 1 Operational conditions related with frequency and quantities of use Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 51/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Duration of exposure at workplace: Frequency of exposure at workplace: Annual amount used per site: Date of issue: xxx The conditions of exposure can be characterised on the basis of an AISE exposure scenario developed for the treatment of drinking water (AISE 2009a). Accordingly, the transfer of concentrated solutions occurs once a day for 10 minutes and treatment in the closed process occurs once a day for 8 hours. The daily and annual amount/emission per site is not considered to be the main determinant for environmental exposure. 3.2 Operational conditions related with substance/ product Physical state Solid / Liquid Concentration of substance in mixture No information about the concentration of the substance in solid form or in dilute solutions is available. In the first-tier assessment of exposure the concentration of TKPP in solids will be set to 100% w/w and the concentration in the working solution to > 25% w/w, respectively. 3.3 Other relevant operational conditions Not applicable. 4. Risk Management Measures 4.1 RMMs related to workers Organisational measures The employer must ensure that the required PPE is available and used according to instructions (provide training if necessary). PPE are required when breaching the system or handling the pure substance and concentrated solutions. Eye wash stations should be available in case of accidental contact. Technical measures Respiratory protection Transport over pipes, technical barrel filling/emptying of barrel with automatic systems (suction pumps etc.) (Good practice) Use of pliers, grip arms with long handles with manual use “to avoid direct contact and exposure by splashes (no working over one’s head)” (Good practice) Store in cool, dry, clean, well ventilate areas. (Good practice). Local exhaust ventilation may be present. Workers wear appropriate personal protection equipment, such as gloves, working suits and safety glasses, when handling the TKPP in solid form or as solutions. Respiratory protection: Respiratory protection is required when workers are exposure to dusts, if LEV with an efficiency of ≥90% is not available. Exposure to dusts from the handling of solid materials should be reduced by the use of local exhaust ventilation (efficiency of at least 90%, please see below for specific requirements). If outdoors PRE may be required. NOTE. For certain processes an efficiency of ≥95% is assumed. Please see below exposure summary for details It is assumed that professional locations may not have sufficient local exhaust ventilation, therefore , If local exhaust ventilation is not available then it will be necessary to use personal respiratory protection that is compliant with EN141 or EN 405 and has a sufficient efficiency (see table below for assumed APF and/or efficiency values). Hand protection Hand protection is recommended: impervious chemical resistant protective gloves. Material: Material of gloves: Butyl rubber, BR. Fluorocarbon rubber (Viton). Nitrile rubber, NBR. Natural rubber, NR. Chloroprene rubber, CR. Neoprene gloves. Eye protection Workers handling concentrated TKPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. Goggles or face protection shield should be consistent with EN 166 or equivalent. Skin and body Wearing of suitable protective clothing and rubber boots is recommended. Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 52/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx protection Hygiene measures Keep away from foodstuffs, drinks and tobacco. Wash hands before breaks and at end of work. Keep work clothes separate. 4.2 RMMs related to the environment Organisational measures Emissions to the environment must meet the requirements of Council Directive 96/61/EC and National Regulations concerning phosphate in industrial wastewater. Abatement measures related with wastewater The efficiency of the process is maximised in such a way that minimal emission of phosphates into the wastewater will occur. In addition, phosphate can be precipitated from the wastewater by addition of metal ions. Abatement measures waste air and solid waste Emissions of particles into the air of workplaces or the atmosphere can be significantly reduced by the use of cyclones, gas scrubbers or bag filters. Solid and liquid waste has to be incinerated or appropriately disposed of as chemical waste. 4.3 Waste related measures Type of waste Liquid waste, solid residues, packaging materials. Disposal technique The release of phosphates to wastewater is highly regulated. The residue of the containers or the used container itself should be disposed in accordance with local requirements. See Section 13 of the SDS for more information. Not determined. Fraction released to environment during waste treatment 5. Prediction of exposure and comparison of predicted exposure with DNELs (Risk Characterisation) 5.1. Human exposure Exposure estimation tool(s) Workers (oral) Workers (inhalation) DNEL: Worker, longterm, systemic, inhalation: 3 44.08 mg/m General dust exposure limit: 10 mg/m3 Revision date: X ECETOC TRA (2010). MEASE(EBRC, Eurometaux, 2010): Used to assess exposure to inorganic solutions and handling of solid inorganics (PROC 26). The substance should be used in the drinking water treatment in such a way that the final concentration of phosphate in drinking should not exceed the maximum admissible concentration of 5 mg/L given in the Council Directive 80/778/EEC relating to the quality of water intended for human consumption. It is also considered that workplace exposure limits for dust are applicable to this substance in the countries in which the substance is manufactured and used. Therefore, the exposure estimates will also be compared against a relevant general dust limit for an inhalable fraction of 10 mg/m3 as described by the occupational exposure limits detailed in the Technical Rules for Hazardous Materials – TRGS 900, January 2006 (Germany).This applies to both industrial and professional use as although the two settings are not directly comparable, it may be prudent to assess both the DNEL and the industrial against the same values both for consistency and for worker safety. A comparison of both the DNEL and a dust limit will ensure that downstream users have enough information on the required RMMs to ensure safe use in line with regional or national limits. INDUSTRIAL USERS: Various industrial activities associated with the treatment of industrial waters and wastewater may result in inhalation exposure of workers to TKPP. The risk characterisation ratios for these activities are given in the table below. Workers handling concentrated TKPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. The use of appropriate gloves and working suits is recommended. It is concluded that Version: XX NB. Please read the NOTICE on the front page Page 53/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx conditions can be defined under which the potential health risks from the use of TKPP in treatment of industrial waters and wastewater are adequately controlled. Table 1. Exposure scenario: Risk characterisation for the industrial use of TKPP in water treatment Location: Indoors (In) / Outdoors (Out) Activity type: Industrial Conclusion RCR (OEL) Conclusion RCR (DNEL) Airborne TKPP conc. (mg/m3) Weight fraction (%) PRE Duration (hours) LEV Location Process Category Activities performed with TKPP solutions In No >4 No > 25 0.001 0.00002 Risk controlled 0.0001 Out* 30% >4 No > 25 0.0007 0.00002 Risk controlled 0.00007 In No >4 No > 25 0.001 0.00002 Risk controlled 0.0001 Out* 30% >4 No > 25 0.0007 0.00002 Risk controlled 0.00007 In No >4 No > 25 20.00 0.45372 Risk controlled 2 In 90% >4 No > 25 2.00 0.04537 Risk controlled 0.2 In No >4 75% > 25 5.00 0.11343 Risk controlled 0.5 Out* 30% >4 No > 25 14.00 0.31760 Risk controlled 1.4 Out* 30% >4 75% > 25 3.50 0.07940 Risk controlled 0.35 In No >4 No > 25 0.01 0.00023 Risk controlled 0.001 Out* 30% >4 No > 25 0.007 0.00016 Risk controlled 0.0007 In No >4 No > 25 0.01 0.00023 Risk controlled 0.001 Out* 30% >4 No > 25 0.007 0.00016 Risk controlled 0.0007 In No >4 No > 25 0.01 0.00023 Risk controlled 0.001 Out* 30% >4 No > 25 0.007 0.00016 Risk controlled 0.0007 In No >4 No > 25 0.05 0.00113 Risk controlled 0.005 Out* 30% >4 No > 25 0.035 0.00079 Risk controlled Activities performed with solids of low dustiness In No >4 No 100 0.01 0.0002 Risk controlled 0.001 Out 30% >4 No 100 0.007 0.0002 Risk controlled 0.0007 In No >4 No 100 0.01 0.0002 Risk controlled 0.001 2 Out 30% >4 No 100 0.007 0.0002 Risk controlled 0.0007 6 In No >4 No 100 0.10 0.0023 Risk controlled 0.01 In No >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 0.70 0.0159 Risk controlled 0.07 1 2 7 8b 9 14 19 1 7 Revision date: X Version: XX NB. Please read the NOTICE on the front page 0.0035 Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Page 54/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate 8b 9 14 19 22a pt<mp Low Fugacity 22b pt ≈ mp - Med Fugacity 22c pt > mp - High Fugacity 26 Date of issue: xxx In No >4 No 100 0.10 0.0023 Risk controlled 0.01 Out 30% >4 No 100 0.07 0.0016 Risk controlled 0.007 In No >4 No 100 0.10 0.0023 Risk controlled 0.01 Out 30% >4 No 100 0.07 0.0016 Risk controlled 0.007 In No >4 No 100 0.10 0.0023 Risk controlled 0.01 Out 30% >4 No 100 0.07 0.0016 Risk controlled 0.007 In No >4 No 100 0.50 0.0113 Risk controlled 0.05 Out 30% >4 No 100 0.35 0.0079 Risk controlled 0.035 In No >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 0.70 0.0159 Risk controlled 0.07 In No >4 No 100 3.00 0.0681 Risk controlled 0.3 Out 30% >4 No 100 2.10 0.0476 Risk controlled 0.21 In No >4 No 100 10.00 0.2269 Risk controlled 1 In 90% >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 7.00 0.1588 Risk controlled 0.7 In No >4 No 100 1.50 0.0340 Risk controlled 0.15 Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Out* 30% >4 No 100 1.05 0.0238 Risk controlled 0.105 Risk controlled Activities performed with solids of medium dustiness 1 2 6 In No >4 No 100 0.01 0.0002 Risk controlled 0.001 Out 30% >4 No 100 0.007 0.0002 Risk controlled 0.0007 In No >4 No 100 0.50 0.0113 Risk controlled 0.05 Out 30% >4 No 100 0.35 0.0079 Risk controlled 0.035 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 In No >4 No 100 20.00 0.4537 Risk controlled 2 In 95% >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 14.00 0.3176 Risk controlled 1.4 Out 30% >4 90% 100 1.40 0.0318 Risk controlled 0.14 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 1.00 0.0227 Risk controlled 0.1 7 8b 9 14 Revision date: X Version: XX NB. Please read the NOTICE on the front page Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Page 55/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Risk controlled Risk controlled Risk controlled Risk controlled Out 30% >4 No 100 0.70 0.0159 Risk controlled 0.07 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 19 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 22a pt<mp Low Fugacity In No >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 0.07 0.0016 Risk controlled 0.007 22b pt ≈ mp - Med Fugacity In No >4 No 100 3.00 0.0681 Risk controlled 0.3 Out 30% >4 No 100 2.10 0.0476 Risk controlled 0.21 In No >4 No 100 10.00 0.2269 Risk controlled 1 In 90% >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 7.00 0.1588 Risk controlled 0.7 In No >4 No 100 4.00 0.0907 Risk controlled 0.4 Out* No >4 No 100 2.80 0.0635 Risk controlled Activities performed with solids of high dustiness In No >4 No 100 0.01 0.0002 Risk controlled 0.001 Out 30% >4 No 100 0.007 0.0002 Risk controlled 0.0007 In No >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 0.70 0.0159 Risk controlled 0.07 In No >4 No 100 25.00 0.5672 Risk controlled 2.5 In 90% >4 No 100 2.50 0.0567 Risk controlled 0.25 In No >4 No 100 100.00 2.2686 RMMs required 10 In 95% >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 70.00 1.5880 RMMs required 7 Out 30% >4 90% 100 7.00 0.1588 Risk controlled 0.7 In No >4 No 100 25.00 0.5672 Risk controlled 2.5 In 95% >4 No 100 1.25 0.0284 Risk controlled 0.125 Out 30% >4 No 100 17.50 0.3970 Risk controlled 1.75 Out 30% >4 90% 100 1.75 0.0397 Risk controlled 0.175 In No >4 No 100 20.00 0.4537 Risk controlled 2 In 90% >4 No 100 2.00 0.0454 Risk controlled 0.2 Out 30% >4 No 100 14.00 0.3176 Risk controlled 1.4 Out 30% >4 90% 100 1.40 0.0318 Risk controlled 0.14 In No >4 No 100 10.00 0.2269 Risk controlled 1 In 90% >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 7.00 0.1588 Risk controlled 0.7 In No 4 to 8 No 100 25.00 0.5672 Risk controlled 2.5 In 90% 4 to 8 No 100 2.50 0.0567 Risk controlled 0.25 22c pt ≈ mp – High Fugacity 26 1 2 6 7 8b 9 14 19 Revision date: X Date of issue: xxx Version: XX NB. Please read the NOTICE on the front page Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled 0.28 Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled Risk controlled Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled Risk controlled RMMs required Risk controlled Page 56/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate 22a pt<mp Low Fugacity 22b pt ≈ mp - Med Fugacity 22c pt > mp - High Fugacity 26 Date of issue: xxx Out 30% >4 No 100 17.5 0.3970 Risk controlled 1.75 Out 30% >4 90% 100 1.75 0.0397 Risk controlled 0.175 In No >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 0.70 0.0159 Risk controlled 0.07 In No >4 No 100 3.00 0.0681 Risk controlled 0.3 Out 30% >4 No 100 2.10 0.0476 Risk controlled 0.21 In No >4 No 100 10.00 0.2269 Risk controlled 1 In 90% >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 7.00 0.1588 Risk controlled 0.7 In No >4 No 100 10.00 0.2269 Risk controlled 1 In 75% >4 No 100 2.50 0.0567 Risk controlled 0.25 Out* 30% >4 No 100 7.00 0.1588 Risk controlled 0.7 Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled RMMs required Risk controlled Risk controlled * Outdoor exposure of industrial workers assumed to be reduced by 30% to give consistency with ECETOC calculations for solids PROFESSIONAL USERS: Various professional activities associated with the treatment of industrial waters and wastewater may result in inhalation exposure of workers to TKPP. The risk characterisation ratios for these activities are given in the table below. Workers handling concentrated TKPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. The use of appropriate gloves and working suits is recommended. It is concluded that conditions can be defined under which the potential health risks from the use of TKPP in the professional treatment of industrial waters and wastewater are adequately controlled. Table 2. Exposure scenario: Risk characterisation for the professional use of TKPP in water treatment Location: Indoors (In) / Outdoors (Out) Activity type: Professional Weight fraction (%) Airborne TKPP conc. (mg/m3) RCR (DNEL) Conclusion RCR (OEL) No > 25 0.10 0.0023 Risk controlled 0.01 Out 30% >4 No > 25 0.071 0.0016 Risk controlled 0.0071 In No >4 No > 25 0.05 0.0011 Risk controlled 0.005 Out 30% >4 No > 25 0.036 0.0008 Risk controlled 0.0036 In No >4 No > 25 0.05 0.0011 Risk controlled 0.005 8b Out 30% >4 No > 25 0.036 0.0008 Risk controlled 0.0036 9 In No >4 No > 25 0.05 0.0011 Risk controlled 0.005 Version: XX NB. Please read the NOTICE on the front page Conclusion PRE Revision date: X Duration (hours) >4 8a LEV No 5 Location Process Category In Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Page 57/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate 11 19 5 8a 8b 9 11 19 5 8a 8b 9 11 Revision date: X Date of issue: xxx Out 30% >4 No > 25 0.036 0.0008 Risk controlled 0.0036 In No >4 No > 25 20.00 0.4537 Risk controlled 2 In 80% >4 No > 25 4.00 0.0907 Risk controlled 0.4 Out 30% >4 No > 25 14.25 0.3233 Risk controlled 1.425 Out 30% >4 75% > 25 3.56 0.0808 Risk controlled 0.356 In No >4 No > 25 0.05 0.0011 Risk controlled 0.005 Out 30% >4 No > 25 0.05 0.0011 Risk controlled Activities performed with solids of low dustiness 0.005 In No >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 0.70 0.0159 Risk controlled 0.07 In No >4 No 100 0.50 0.0113 Risk controlled 0.05 Out 30% >4 No 100 0.35 0.0079 Risk controlled 0.035 In No >4 No 100 0.50 0.0113 Risk controlled 0.05 Out 30% >4 No 100 0.35 0.0079 Risk controlled 0.035 In No >4 No 100 0.50 0.0113 Risk controlled 0.05 Out 30% >4 No 100 0.35 0.0079 Risk controlled 0.035 In No >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 0.70 0.0159 Risk controlled 0.07 In No >4 No 100 0.50 0.0113 Risk controlled 0.05 Out 30% >4 No 100 0.35 0.0079 Risk controlled Activities performed with solids of medium dustiness In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 20.00 0.4537 Risk controlled 2 In 80% >4 No 100 4.00 0.0907 Risk controlled 0.4 In No >4 90% 100 2.00 0.0454 Risk controlled 0.2 Out 30% >4 No 100 14.00 0.3176 Risk controlled 1.4 Version: XX NB. Please read the NOTICE on the front page 0.035 Risk controlled RMMs required Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled RMMs required Page 58/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate 19 5 8a 8b 9 10 11 Revision date: X Date of issue: xxx Out 30% >4 90% 100 1.40 0.0318 Risk controlled 0.14 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled Activities performed with solids of high dustiness In No >4 No 100 50.00 1.1343 RMMs required 5 In 80% >4 No 100 10.00 0.2269 Risk controlled 1 In 80% 1 to 4 No 100 6.00 0.1361 Risk controlled 0.6 In No >4 90% 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 35.00 0.7940 Risk controlled 3.5 Out 30% >4 90% 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 50.00 1.1343 RMMs required 5 In 80% >4 No 100 10.00 0.2269 Risk controlled 1 In 80% 1 to 4 No 100 6.00 0.1361 Risk controlled 0.6 In No >4 90% 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 35.00 0.7940 Risk controlled 3.5 In No >4 No 100 50.00 1.1343 RMMs required 5 In 80% >4 No 100 10.00 0.2269 Risk controlled 1 In 80% 1 to 4 No 100 6.00 0.1361 Risk controlled 0.6 In No >4 90% 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 35.00 0.7940 Risk controlled 3.5 Out 30% >4 90% 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 20.00 0.4537 Risk controlled 2 In 80% >4 No 100 4.00 0.0907 Risk controlled 0.4 In No >4 90% 100 2.00 0.0454 Risk controlled 0.2 Out 30% >4 No 100 14.00 0.3176 Risk controlled 1.4 Out 30% >4 90% 100 1.40 0.0318 Risk controlled 0.14 In No >4 No 100 10.00 0.2269 Risk controlled 1 In 80% >4 No 100 2.00 0.0454 Risk controlled 0.2 In No >4 90% 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 7.00 0.1588 Risk controlled 0.7 In No >4 No 100 200.00 4.5372 RMMs required 20 In 80% >4 No 100 40.00 0.9074 Risk controlled 4 In 80% 0.25 to 1 No 100 8.00 0.1815 Risk controlled 0.8 In No >4 90% 100 20.00 0.4537 Risk controlled 2 Version: XX NB. Please read the NOTICE on the front page 0.35 Risk controlled Risk controlled Risk controlled RMMs required RMMs required Risk controlled Risk controlled RMMs required Risk controlled RMMs required RMMs required Risk controlled Risk controlled RMMs required RMMs required RMMs required Risk controlled Risk controlled RMMs required Risk controlled RMMs required Risk controlled Risk controlled RMMs required Risk controlled RMMs required Risk controlled Risk controlled Risk controlled RMMs required RMMs required Risk controlled RMMs required Page 59/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate 19 Date of issue: xxx In No 0.25 to 1 90% 100 4.00 0.0907 Risk controlled 0.4 In 80% >4 90% 100 4.00 0.0907 Risk controlled 0.4 Out 30% >4 No 100 140.00 3.1760 RMMs required 14 Out 30% >4 95% 100 7.00 0.1588 Risk controlled 0.7 In No >4 No 100 50.00 1.1343 RMMs required 5 In 80% >4 No 100 10.00 0.2269 Risk controlled 1 In 80% 1 to 4 No 100 3.00 0.0681 Risk controlled 0.3 In No >4 90% 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 35.00 0.7940 Risk controlled 3.5 Out 30% >4 90% 100 3.50 0.0794 Risk controlled 0.35 Risk controlled Risk controlled RMMs required Risk controlled RMMs required RMMs required Risk controlled Risk controlled RMMs required Risk controlled Workers (dermal) No systemic toxicity effects are expected due to the inorganic nature of the substance however local effects may occur but these effects will not be dose-dependent but will depend on the concentration of the substance present in the mixture/solution used in a specific application. Indirect exposure via the environment No indirect exposure of humans via the environment is expected for TKPP, as the substance can be effectively removed from the wastewater. Thus, no assessment of indirect exposure of humans via the environment is performed. Consumer exposure No direct consumer exposure is anticipated with the use of TKPP in water and wastewater treatment. The substance should be used in the drinking water treatment in such a way that the final concentration of phosphate in drinking should not exceed the maximum admissible concentration of 5 mg/L given in the Council Directive 80/778/EEC relating to the quality of water intended for human consumption. It is concluded that the use of TKPP in water and wastewater treatment is of no risk for the general public. 5.2. Environmental exposure (qualitative assessment) Environmental release The use of TKPP can potentially result in aquatic emissions and locally increase the 3phosphate (PO4 ) concentration. Phosphates reaching surface water increase the phosphorus content in the water body which may cause eutrophication and water quality deterioration. Waste water treatment plants (WWTP) Phosphorus should be removed from industrial wastewater before it is released to the environment. This can be done by chemical treatment (by precipitation with the help of aluminium or iron addition) or biological treatments. A high degree of removal can be reliably achieved by the available phosphorus removal techniques. Site-specific conditions such as flow rate of the receiving surface water body and phosphorus concentration in the receiving surface water body should be taken into account when implementing an appropriate wastewater treatment. Council Directive 96/61/EC concerning integrated pollution prevention and control and national regulations concerning phosphates in industrial wastewater have to be followed to minimise the risk of eutrophication due to phosphate releases. Aquatic pelagic compartment No direct acute or long-term adverse effects on aqueous or terrestrial organisms are anticipated with orthophosphates in the environment. Sediments No direct acute or long-term adverse effects on aqueous or sediment organisms are anticipated with orthophosphates in the environment. No direct acute or long-term adverse effects on terrestrial organisms are anticipated with Soil and Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 60/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx groundwater orthophosphates in the environment. Atmospheric compartment The use of TKPP in wastewater treatment is not considered to pose a risk to the atmospheric compartment. Secondary poisoning Bioaccumulation in organisms is not relevant for inorganic phosphates. ES7: Industrial and professional use of washing and cleaning products containing TKPP 1. Short title of exposure scenario 7 Industrial and professional use of washing and cleaning products containing TKPP 2. Description of activities and processes covered in the exposure scenario Sector of use (SU) Product category (PC) Process category (PROC) Article category (AC) Environmental release category (ERC) Revision date: X SU 0: Other: industrial washing and cleaning applications SU 3: Industrial uses: uses of substances as such or in preparations at industrial sites SU 5: Manufacture of textiles, leather, fur SU 20: Health services SU 22: Professional uses PC 3: Air care products PC 8: Biocidal products PC 31: Polishes and wax blends PC 35: Washing and cleaning products PC 36: Water softeners PROC 1: Use in closed process, no likelihood of exposure PROC 2: Use in closed, continuous process with occasional controlled exposure PROC 3: Use in closed batch process (synthesis or formulation) PROC 4: Use in batch and other process (synthesis) where opportunity for exposure arises PROC 5: Mixing or blending in batch processes (multistage and/or significant contact) PROC 7: Industrial spraying PROC 8a: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities PROC 8b: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities PROC 9: Transfer of substance or preparation into small containers (dedicated filling line, including weighing) PROC 10: Roller application or brushing PROC 11: Non industrial spraying PROC 12: Use of blow agents for foam production PROC 13: Treatment of articles by dipping and pouring PROC 19: Hand-mixing with intimate contact and only PPE available. PROC 26: Handling of solid inorganic substances at ambient temperature Not applicable ERC 1: Manufacture of substances ERC 2: Formulation of preparations ERC 3: Formulation in materials ERC 4: Industrial use of processing aids in processes and products, not becoming part of articles ERC 5: Industrial use resulting in inclusion into or onto a matrix ERC 6a: Industrial use resulting in manufacture of another substance (use of intermediates) ERC 6b: Industrial use of reactive processing aids ERC 8a: Wide dispersive indoor use of processing aids in open systems Version: XX NB. Please read the NOTICE on the front page Page 61/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx ERC 8b: Wide dispersive indoor use of reactive substances in open systems ERC 8d: Wide dispersive outdoor use of processing aids in open systems ERC 8e: Wide dispersive outdoor use of reactive substances in open systems 3. Operational conditions 3. 1 Operational conditions related with frequency and quantities of use Duration of exposure at workplace: Frequency of exposure at workplace: Annual amount used per site: The industrial and professional use of cleaners is characterised on the basis of an AISE exposure scenario developed in the context of REACH (AISE 2009a) for the use of such products. Accordingly, the transfer of undiluted cleaners may occur once a day for 10 minutes and the industrial or professional use of diluted solutions may occur once a day for 8 hours. A single worker may be exposed on 220 days per year. The daily and annual amount/emission per site is not considered to be the main determinant for environmental exposure. 3.2 Operational conditions related with substance/ product Physical state Solid / Liquid Concentration of substance in mixture No information about the concentration of the substance in cleaners or in dilute solutions is available. In the first-tier assessment of exposure the concentration of TKPP solid cleaning products was > 10% w/w and the concentration in the liquid products and working solutions was set to > 25% as a worst-case. 3.3 Other relevant operational conditions Not applicable. 4. Risk Management Measures 4.1 RMMs related to workers Organisational measures The employer must ensure that the required PPE is available and used according to instructions (provide training if necessary). PPE are required when breaching the system or handling the pure substance and concentrated solutions. Eye wash stations should be available in case of accidental contact. Technical measures Respiratory protection Revision date: X Transport over pipes, technical barrel filling/emptying of barrel with automatic systems (suction pumps etc.) (Good practice) Use of pliers, grip arms with long handles with manual use “to avoid direct contact and exposure by splashes (no working over one’s head)” (Good practice) Store in cool, dry, clean, well ventilate areas. (Good practice). Local exhaust ventilation may be present. Workers wear appropriate personal protection equipment, such as gloves, working suits and safety glasses, when handling the TKPP in solid form or as solutions. Breathing masks are used during manual high-pressure spraying of solutions onto surfaces. Professional users may wear gloves and safety glasses during transfer of cleaning products and cleaning activities. Respiratory protection: Respiratory protection is required when workers are exposure to dusts, if LEV with an efficiency of ≥90% is not available. Exposure to dusts from the handling of solid materials should be reduced by the use of local exhaust ventilation (efficiency of at least 90%, please see below for specific requirements). If outdoors PRE may be required. NOTE. For certain processes an efficiency of ≥95% is assumed. Please see below exposure summary for details It is assumed that professional locations may not have sufficient local exhaust ventilation, therefore , If local exhaust ventilation is not available then it will be necessary to use personal respiratory protection that is compliant with EN141 or EN 405 and has a sufficient efficiency (see table below for assumed APF and/or efficiency Version: XX NB. Please read the NOTICE on the front page Page 62/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx values). Hand protection Hand protection is recommended: impervious chemical resistant protective gloves. Material: Material of gloves: Butyl rubber, BR. Fluorocarbon rubber (Viton). Nitrile rubber, NBR. Natural rubber, NR. Chloroprene rubber, CR. Neoprene gloves. Eye protection Workers handling concentrated TKPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. Goggles or face protection shield should be consistent with EN 166 or equivalent. Skin and body protection Wearing of suitable protective clothing and rubber boots is recommended. Hygiene measures Keep away from foodstuffs, drinks and tobacco. Wash hands before breaks and at end of work. Keep work clothes separate. 4.2 RMMs related to the environment Organisational measures Emissions to the environment must meet the requirements of Council Directive 96/61/EC and National Regulations concerning phosphate in industrial wastewater. Abatement measures related with wastewater The efficiency of the process is maximised in such a way that minimal emission of phosphates into the wastewater will occur. In addition, phosphate can be precipitated from the wastewater by addition of metal ions. Abatement measures waste air and solid waste Emissions of particles into the air of workplaces or the atmosphere can be significantly reduced by the use of cyclones, gas scrubbers or bag filters. Solid and liquid waste has to be incinerated or appropriately disposed of as chemical waste. 4.3 Waste related measures Type of waste Liquid waste, solid residues, packaging materials. Disposal technique The release of phosphates to wastewater is highly regulated. The residue of the containers or the used container itself should be disposed in accordance with local requirements. See Section 13 of the SDS for more information. Not determined. Fraction released to environment during waste treatment 5. Prediction of exposure and comparison of predicted exposure with DNELs (Risk Characterisation) 5.1. Human exposure Exposure estimation tool(s) Workers (oral) ECETOC TRA (2010). MEASE(EBRC, Eurometaux, 2010): Used to assess exposure to inorganic solutions and handling of solid inorganics (PROC 26). The use of TKPP in industrial and professional washing and cleaning will not notably contribute to the oral intake of phosphates. Workers (inhalation) It is also considered that workplace exposure limits for dust are applicable to this substance in the countries in which the substance is manufactured and used. Therefore, the exposure estimates will also be compared against a relevant general dust limit for an inhalable fraction of 10 mg/m3 as described by the occupational exposure limits detailed in the Technical Rules for Hazardous Materials – TRGS 900, January 2006 (Germany).This applies to both industrial and professional use as although the two settings are not directly comparable, it may be prudent to assess both the DNEL and the industrial against the same values both for consistency and for worker safety. DNEL: Worker, long-term, systemic, inhalation: 3 44.08 mg/m Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 63/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate General dust exposure limit: 10 mg/m3 Date of issue: xxx A comparison of both the DNEL and a dust limit will ensure that downstream users have enough information on the required RMMs to ensure safe use in line with regional or national limits. INDUSTRIAL USERS: Various industrial activities associated with industrial cleaning and washing may result in inhalation exposure of workers to TKPP. The risk characterisation ratios for these activities are given in the table below. Workers handling concentrated TKPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. The use of appropriate gloves and working suits is recommended. It is concluded that conditions can be defined under which the potential health risks from the use of TKPP in industrial cleaning and washing are adequately controlled. Table 1. Exposure scenario: Risk characterisation for the industrial use of TKPP in cleaning applications Location: Indoors (In) / Outdoors (Out) Activity type: Industrial Conclusion RCR (OEL) Conclusion RCR (DNEL) Airborne TKPP conc. (mg/m3) Weight fraction (%) PRE Duration (hours) LEV Location Process Category Activities performed with TKPP solutions In No >4 No > 25 0.001 0.00002 Risk controlled 0.0001 Out* 30% >4 No > 25 0.0007 0.00002 Risk controlled 0.00007 In No >4 No > 25 0.001 0.00002 Risk controlled 0.0001 Out* 30% >4 No > 25 0.0007 0.00002 Risk controlled 0.00007 In No >4 No > 25 0.01 0.00023 Risk controlled 0.001 Out* 30% >4 No > 25 0.007 0.00016 Risk controlled 0.0007 In No >4 No > 25 0.05 0.00113 Risk controlled 0.005 Out* 30% >4 No > 25 0.035 0.00079 Risk controlled 0.0035 In No >4 No > 25 0.05 0.00113 Risk controlled 0.005 Out* 30% >4 No > 25 0.035 0.00079 Risk controlled 0.0035 In No >4 No > 25 20.00 0.45372 Risk controlled 2 In 90% >4 No > 25 2.00 0.04537 Risk controlled 0.2 In No >4 75% > 25 5.00 0.11343 Risk controlled 0.5 Out* 30% >4 No > 25 14.00 0.31760 Risk controlled 1.4 Out* 30% >4 75% > 25 3.50 0.07940 Risk controlled 0.35 In No >4 No > 25 0.01 0.00023 Risk controlled 0.001 8b Out* 30% >4 No > 25 0.007 0.00016 Risk controlled 0.0007 9 In No >4 No > 25 0.01 0.00023 Risk controlled 0.001 1 2 3 4 5 7 Revision date: X Version: XX NB. Please read the NOTICE on the front page Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Page 64/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate 10 12 13 19 1 2 3 4 5 7 8b 9 10 13 19 Revision date: X Date of issue: xxx Out* 30% >4 No > 25 0.007 0.00016 Risk controlled 0.0007 In No >4 No > 25 0.05 0.00113 Risk controlled 0.005 Out* 30% >4 No > 25 0.00079 Risk controlled 0.0035 In No >4 No > 25 0.035 < 0.001 <0.00002 Risk controlled <0.0001 <0.00002 Risk controlled <0.0001 Out* 30% >4 No > 25 < 0.001 In No >4 No > 25 0.01 0.00023 Risk controlled 0.001 Out* 30% >4 No > 25 0.007 0.00016 Risk controlled 0.0007 In No >4 No > 25 0.05 0.00113 Risk controlled 0.005 Out* 30% >4 In No >4 No 100 0.01 0.0002 Risk controlled 0.001 Out 30% >4 No 100 0.007 0.0002 Risk controlled 0.0007 In No >4 No 100 0.01 0.0002 Risk controlled 0.001 Out 30% >4 No 100 0.007 0.0002 Risk controlled 0.0007 In No >4 No 100 0.10 0.0023 Risk controlled 0.01 Out 30% >4 No 100 0.07 0.0016 Risk controlled 0.007 In No >4 No 100 0.50 0.0113 Risk controlled 0.05 Out 30% >4 No 100 0.35 0.0079 In No >4 No 100 0.50 0.0113 Risk controlled 0.05 Out 30% >4 No 100 0.35 0.0079 Risk controlled 0.035 In No >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 0.70 0.0159 Risk controlled 0.07 In No >4 No 100 0.10 0.0023 Risk controlled 0.01 Out 30% >4 No 100 0.07 0.0016 Risk controlled 0.007 In No >4 No 100 0.10 0.0023 Risk controlled 0.01 Out 30% >4 No 100 0.07 0.0016 Risk controlled 0.007 In No >4 No 100 0.50 0.0113 Risk controlled 0.05 Out 30% >4 No 100 0.35 0.0079 Risk controlled 0.035 In No >4 No 100 0.10 0.0023 Risk controlled 0.01 Out 30% >4 No 100 0.07 0.0016 Risk controlled 0.007 In No >4 No 100 0.50 0.0113 Risk controlled 0.05 Out 30% >4 Risk controlled No > 25 0.035 0.00079 Activities performed with solids of low dustiness 0.035 Risk controlled No 100 0.35 0.0079 Activities performed with solids of medium dustiness Version: XX NB. Please read the NOTICE on the front page 0.0035 0.035 Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Page 65/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate In No >4 No 100 0.01 0.0002 Risk controlled 0.001 Out 30% >4 No 100 0.007 0.0002 Risk controlled 0.0007 In No >4 No 100 0.50 0.0113 Risk controlled 0.05 Out 30% >4 No 100 0.35 0.0079 Risk controlled 0.035 In No >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 0.70 0.0159 Risk controlled 0.07 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 20.00 0.4537 Risk controlled 2 In 95% >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 14.00 0.3176 Risk controlled 1.4 Out 30% >4 90% 100 1.40 0.0318 Risk controlled 0.14 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 0.70 0.0159 Risk controlled 0.07 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 In No >4 No 100 0.01 0.0002 Risk controlled 0.001 Out 30% >4 No 100 0.007 0.0002 Risk controlled 0.0007 In No >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 0.70 0.0159 Risk controlled 0.07 In No >4 No 100 1.00 0.0227 Risk controlled 0.1 3 Out 30% >4 No 100 0.70 0.0159 Risk controlled 0.07 4 In No >4 No 100 25.00 0.5672 Risk controlled 2.5 1 2 3 4 5 7 8b 9 10 13 19 1 2 Revision date: X Date of issue: xxx Risk controlled No 100 3.50 0.0794 Activities performed with solids of high dustiness Version: XX NB. Please read the NOTICE on the front page 0.35 Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Page 66/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate 5 7 8b 9 10 13 19 Date of issue: xxx In 90% >4 No 100 2.50 0.0567 Risk controlled 0.25 Out 30% >4 No 100 17.50 0.3970 Risk controlled 1.75 Out 30% >4 90% 100 1.75 0.0397 Risk controlled 0.175 In No >4 No 100 25.00 0.5672 Risk controlled 2.5 In 90% >4 No 100 2.50 0.0567 Risk controlled 0.25 Out 30% >4 No 100 17.50 0.3970 Risk controlled 1.75 Out 30% >4 90% 100 1.75 0.0397 Risk controlled 0.175 In No >4 No 100 100.00 2.2686 In 95% >4 No 100 5.00 0.1134 Out 30% >4 No 100 70.00 1.5880 Out 30% >4 90% 100 7.00 0.1588 Risk controlled 0.7 In No >4 No 100 25.00 0.5672 Risk controlled 2.5 In 95% >4 No 100 1.25 0.0284 Risk controlled 0.125 Out 30% >4 No 100 17.50 0.3970 Risk controlled 1.75 Out 30% >4 90% 100 1.75 0.0397 Risk controlled 0.175 In No >4 No 100 20.00 0.4537 Risk controlled 2 In 90% >4 No 100 2.00 0.0454 Risk controlled 0.2 Out 30% >4 No 100 14.00 0.3176 Risk controlled 1.4 Out 30% >4 90% 100 1.40 0.0318 Risk controlled 0.14 In No >4 No 100 10.00 0.2269 Risk controlled 1 In 90% >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 7.00 0.1588 Risk controlled 0.7 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No 4 to 8 No 100 25.00 0.5672 Risk controlled 2.5 In 90% 4 to 8 No 100 2.50 0.0567 Risk controlled 0.25 Out 30% >4 No 100 17.5 0.3970 Risk controlled 1.75 Out 30% >4 90% 100 1.75 0.0397 Risk controlled 0.175 10 Risk controlled 0.5 7 Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled RMMs required Risk controlled PROFESSIONAL USERS: Various professional activities associated with professional cleaning and washing may result in inhalation exposure of workers to TKPP. The risk characterisation ratios for these activities are given in the table below. Workers handling concentrated TKPP solutions or pure, solid substances are obliged to wear chemical resistant safety Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 67/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx goggles. The use of appropriate gloves and working suits is recommended. It is concluded that conditions can be defined under which the potential health risks from the use of TKPP in professional cleaning and washing are adequately controlled. PROFESSIONAL USERS: Table 2. Exposure scenario: Risk characterisation for the professional use of TKPP in cleaning applications Location: Indoors (In) / Outdoors (Out) Activity type: Industrial Conclusion RCR (OEL) Conclusion RCR (DNEL) Airborne TKPP conc. (mg/m3) Weight fraction (%) PRE Duration (hours) LEV Location Process Category Activities performed with TKPP solutions In No >4 No > 25 0.10 0.0023 Risk controlled 0.01 Out 30% >4 No > 25 0.071 0.0016 Risk controlled 0.0071 In No >4 No > 25 0.10 0.0023 Risk controlled 0.01 Out 30% >4 No > 25 0.071 0.0016 Risk controlled 0.0071 In No >4 No > 25 0.05 0.0011 Risk controlled 0.005 Out 30% >4 No > 25 0.036 0.0008 Risk controlled 0.0036 In No >4 No > 25 0.05 0.0011 Risk controlled 0.005 Out 30% >4 No > 25 0.036 0.0008 Risk controlled 0.0036 In No >4 No > 25 0.05 0.0011 Risk controlled 0.005 Out 30% >4 No > 25 0.036 0.0008 Risk controlled 0.0036 In No >4 No > 25 20.00 0.4537 Risk controlled 2 In Out 80% 30% >4 >4 No No > 25 > 25 4.00 14.25 0.0907 0.3233 Risk controlled Risk controlled 0.4 1.425 Out 30% >4 75% > 25 3.56 0.0808 Risk controlled 0.356 In No >4 No > 25 0.05 0.0011 Risk controlled 0.005 Out 30% >4 No > 25 0.036 0.0008 Risk controlled 0.0036 In No >4 No > 25 0.05 0.0011 Risk controlled 0.005 Out 30% >4 No > 25 0.05 0.0011 Risk controlled Activities performed with solids of low dustiness 0.005 In No >4 No 100 1.00 0.0227 Risk controlled 0.1 4 Out 30% >4 No 100 0.70 0.0159 Risk controlled 0.07 5 In No >4 No 100 1.00 0.0227 Risk controlled 0.1 4 5 8a 9 10 11 13 19 Revision date: X Version: XX NB. Please read the NOTICE on the front page Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Page 68/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate 8a 9 10 11 13 19 26 4 5 8a 9 10 11 13 Revision date: X Date of issue: xxx Out 30% >4 No 100 0.70 0.0159 Risk controlled 0.07 In No >4 No 100 0.50 0.0113 Risk controlled 0.05 Out 30% >4 No 100 0.35 0.0079 Risk controlled 0.035 In No >4 No 100 0.50 0.0113 Risk controlled 0.05 Out 30% >4 No 100 0.35 0.0079 Risk controlled 0.035 In No >4 No 100 0.50 0.0113 Risk controlled 0.05 Out 30% >4 No 100 0.35 0.0079 Risk controlled 0.035 In No >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 0.70 0.0159 Risk controlled 0.07 In No >4 No 100 0.50 0.0113 Risk controlled 0.05 Out 30% >4 No 100 0.35 0.0079 Risk controlled 0.035 In No >4 No 100 0.50 0.0113 Risk controlled 0.05 Out 30% >4 No 100 0.35 0.0079 Risk controlled 0.035 In No 4 to 8 No 100 3.00 0.0681 Risk controlled 0.3 Out 30% 4 to 8 No 100 2.14 0.0485 Risk controlled Activities performed with solids of medium dustiness In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out In 30% No >4 >4 No No 100 100 3.50 5.00 0.0794 Risk controlled 0.35 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 20.00 0.4537 Risk controlled 2 In 80% >4 No 100 4.00 0.0907 Risk controlled 0.4 In No >4 90% 100 2.00 0.0454 Risk controlled 0.2 Out 30% >4 No 100 14.00 0.3176 Risk controlled 1.4 Out 30% >4 90% 100 1.40 0.0318 Risk controlled 0.14 0.1134 0.0794 Risk controlled Risk controlled 0.5 0.35 In No >4 No 100 5.00 Out 30% >4 No 100 3.50 Version: XX NB. Please read the NOTICE on the front page 0.214 Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk Page 69/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx In No >4 No 100 5.00 Out 30% >4 No 100 3.50 In No 4 to 8 No 100 8.00 Out 30% 4 to 8 No 100 5.70 19 26 0.1134 Risk controlled 0.5 0.0794 Risk controlled 0.35 0.1815 Risk controlled 0.8 0.1293 Risk controlled Activities performed with solids of high dustiness 4 5 8a 9 10 11 Revision date: X 0.57 In No >4 No 100 50.00 1.1343 RMMs required 5 In 80% >4 No 100 10.00 0.2269 Risk controlled 1 In 80% 1 to 4 No 100 6.00 0.1361 Risk controlled 0.6 In No >4 90% 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 35.00 0.7940 Risk controlled 3.5 Out 30% >4 90% 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 50.00 1.1343 RMMs required 5 In 80% >4 No 100 10.00 0.2269 Risk controlled 1 In 80% 1 to 4 No 100 6.00 0.1361 Risk controlled 0.6 In No >4 90% 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 35.00 0.7940 Risk controlled 3.5 Out 30% >4 90% 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 50.00 1.1343 RMMs required 5 In 80% >4 No 100 10.00 0.2269 Risk controlled 1 In 80% 1 to 4 No 100 6.00 0.1361 Risk controlled 0.6 In No >4 90% 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 35.00 0.7940 Risk controlled 3.5 In No >4 No 100 20.00 0.4537 Risk controlled 2 In 80% >4 No 100 4.00 0.0907 Risk controlled 0.4 In No >4 90% 100 2.00 0.0454 Risk controlled 0.2 Out 30% >4 No 100 14.00 0.3176 Risk controlled 1.4 Out 30% >4 90% 100 1.40 0.0318 Risk controlled 0.14 In No >4 No 100 10.00 0.2269 Risk controlled 1 In 80% >4 No 100 2.00 0.0454 Risk controlled 0.2 In No >4 90% 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 7.00 0.1588 Risk controlled 0.7 In No >4 No 100 200.00 4.5372 RMMs required 20 In 80% >4 No 100 40.00 0.9074 Risk controlled 4 Version: XX NB. Please read the NOTICE on the front page controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required RMMs required Risk controlled Risk controlled RMMs required Risk controlled RMMs required RMMs required Risk controlled Risk controlled RMMs required Risk controlled RMMs required RMMs required Risk controlled Risk controlled RMMs required RMMs required Risk controlled Risk controlled RMMs required Risk controlled RMMs required Risk controlled Risk controlled Risk controlled RMMs required RMMs required Page 70/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate 13 19 26 Date of issue: xxx In 80% 0.25 to 1 No 100 8.00 0.1815 Risk controlled 0.8 In No >4 90% 100 20.00 0.4537 Risk controlled 2 In No 0.25 to 1 90% 100 4.00 0.0907 Risk controlled 0.4 In 80% >4 90% 100 4.00 0.0907 Risk controlled 0.4 Out 30% >4 No 100 140.00 3.1760 RMMs required 14 Out 30% >4 95% 100 7.00 0.1588 Risk controlled 0.7 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 50.00 1.1343 RMMs required 5 In 80% >4 No 100 10.00 0.2269 Risk controlled 1 In 80% 1 to 4 No 100 3.00 0.0681 Risk controlled 0.3 In No >4 90% 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 35.00 0.7940 Risk controlled 3.5 Out 30% >4 90% 100 3.50 0.0794 Risk controlled 0.35 In No 4 to 8 No 100 20.00 0.4537 Risk controlled 2 In 80% 4 to 8 No 100 4.00 0.0907 Risk controlled 0.4 In No 4 to 8 75% 100 5.00 0.1134 Risk controlled 0.5 Out 30% 4 to 8 No 100 14.25 0.3233 Risk controlled 1.425 Out 30% 4 to 8 75% 100 3.56 0.0808 Risk controlled 0.356 Risk controlled RMMs required Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled RMMs required RMMs required Risk controlled Risk controlled RMMs required Risk controlled RMMs required Risk controlled Risk controlled RMMs required Risk controlled Workers (dermal) No systemic toxicity effects are expected due to the inorganic nature of the substance however local effects may occur but these effects will not be dose-dependent but will depend on the concentration of the substance present in the mixture/solution used in a specific application. Indirect exposure via the environment No indirect exposure of humans via the environment is expected for TKPP, as the substance can be effectively removed from the wastewater. Thus, no assessment of indirect exposure of humans via the environment is performed. Consumer exposure No direct consumer exposure is anticipated with the industrial and professional use of washing and cleaning products. It is concluded that the use of TKPP in industrial and professional use of washing and cleaning products is of no risk for the general public. 5.2. Environmental exposure (qualitative assessment) Environmental release The use of TKPP can potentially result in aquatic emissions and locally increase the 3phosphate (PO4 ) concentration. Phosphates reaching surface water increase the phosphorus content in the water body which may cause eutrophication and water quality deterioration. Waste water treatment plants (WWTP) Phosphorus should be removed from industrial wastewater before it is released to the environment. This can be done by chemical treatment (by precipitation with the help of aluminium or iron addition) or biological treatments. A high degree of removal can be reliably achieved by the available phosphorus removal techniques. Site-specific conditions such as flow rate of the receiving surface water body and phosphorus concentration in the receiving surface water body should be taken into account when implementing an appropriate wastewater treatment. Council Directive 96/61/EC Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 71/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx concerning integrated pollution prevention and control and national regulations concerning phosphates in industrial wastewater have to be followed to minimise the risk of eutrophication due to phosphate releases. Aquatic pelagic compartment No direct acute or long-term adverse effects on aqueous or terrestrial organisms are anticipated with orthophosphates in the environment. Sediments Soil and groundwater No direct acute or long-term adverse effects on aqueous or sediment organisms are anticipated with orthophosphates in the environment. No direct acute or long-term adverse effects on terrestrial organisms are anticipated with orthophosphates in the environment. Atmospheric compartment The use of TKPP in washing and cleaning products is not considered to pose a risk to the atmospheric compartment. Secondary poisoning Bioaccumulation in organisms is not relevant for inorganic phosphates. ES8: Application in oil well and other drilling fluid applications, liquefying and conditioning earths, mud, clays 1. Short title of exposure scenario 8 Application in oil well and other drilling fluid applications, liquefying and conditioning earths, mud, clays 2. Description of activities and processes covered in the exposure scenario Sector of use (SU) SU 2a: Mining (without offshore industries) SU 2b: Offshore industries SU 3: Industrial uses: uses of substances as such or in preparations at industrial sites Product category (PC) PC 17: Hydraulic fluids PC 20: Products such as ph-regulators, flocculants, precipitants, neutralisation agents Process category (PROC) PROC 3: Use in closed batch process (synthesis or formulation) PROC 4: Use in batch and other process (synthesis) where opportunity for exposure arises PROC 5: Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact) PROC 8b: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities PROC 9: Transfer of substance or preparation into small containers (dedicated filling line, including weighing) PROC 13: Treatment of articles by dipping and pouring PROC 18: Greasing at high energy conditions PROC 19: Hand-mixing with intimate contact and only PPE available. PROC 26: Handling of solid inorganic substances at ambient temperature Not applicable Article category (AC) Environmental release category (ERC) ERC 1: Manufacture of substances ERC 2: Formulation of preparations ERC 4: Industrial use of processing aids in processes and products, not becoming part of articles ERC 6a: Industrial use resulting in manufacture of another substance (use of intermediates) ERC 6b: Industrial use of reactive processing aids ERC 8d: Wide dispersive outdoor use of processing aids in open systems ERC 9b: Wide dispersive outdoor use of substances in closed systems 3. Operational conditions Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 72/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx 3. 1 Operational conditions related with frequency and quantities of use Duration of exposure at workplace: Frequency of exposure at workplace: Annual amount used per site: Drilling may be operated on 365 days a year for 24 hours a day. A single worker may be exposed on 220 days per year. No information about frequency and duration of the various tasks is available. In the first-tier assessment of exposure a frequency of once a day and an exposure duration of 8 hours was considered. The daily and annual amount/emission per site is not considered to be the main determinant for environmental exposure. 3.2 Operational conditions related with substance/ product Physical state Solid / Liquid Concentration of substance in mixture No information about the concentration of the substance in solid products and dilute solutions is available. In the first-tier assessment of exposure the concentration of TKPP in the solid preparations was 100% w/w and the concentration in the working solution was > 25%. 3.3 Other relevant operational conditions Not applicable. 4. Risk Management Measures 4.1 RMMs related to workers Organisational measures The employer must ensure that the required PPE is available and used according to instructions (provide training if necessary). PPE are required when breaching the system or handling the pure substance and concentrated solutions. Eye wash stations should be available in case of accidental contact. Technical measures Respiratory protection Hand protection Eye protection Skin and body protection Revision date: X Store in cool, dry, clean, well ventilate areas. (Good practice). Personal respiratory equipment may be available. Workers wear appropriate personal protection equipment, such as gloves, working suits and safety glasses, when handling the TKPP in solid form or as solutions. Respiratory protection: Respiratory protection is required when workers are exposure to dusts, if LEV with an efficiency of ≥90% is not available. Exposure to dusts from the handling of solid materials should be reduced by the use of local exhaust ventilation (efficiency of at least 90%, please see below for specific requirements). If outdoors PRE may be required. NOTE. For certain processes an efficiency of ≥95% is assumed. Please see below exposure summary for details It is assumed that professional locations may not have sufficient local exhaust ventilation, therefore , If local exhaust ventilation is not available then it will be necessary to use personal respiratory protection that is compliant with EN141 or EN 405 and has a sufficient efficiency (see table below for assumed APF and/or efficiency values). Hand protection is recommended: impervious chemical resistant protective gloves. Material: Material of gloves: Butyl rubber, BR. Fluorocarbon rubber (Viton). Nitrile rubber, NBR. Natural rubber, NR. Chloroprene rubber, CR. Neoprene gloves. Workers handling concentrated TKPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. Goggles or face protection shield should be consistent with EN 166 or equivalent. Wearing of suitable protective clothing and rubber boots is recommended. Version: XX NB. Please read the NOTICE on the front page Page 73/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Hygiene measures Date of issue: xxx Keep away from foodstuffs, drinks and tobacco. Wash hands before breaks and at end of work. Keep work clothes separate. 4.2 RMMs related to the environment Organisational measures Emissions to the environment must meet the requirements of Council Directive 96/61/EC and National Regulations concerning phosphate in industrial wastewater. Abatement measures related with wastewater Phosphate can be precipitated from the wastewater by addition of metal ions. Abatement measures waste air and solid waste Solid and liquid waste has to be incinerated or appropriately disposed of as chemical waste. 4.3 Waste related measures Type of waste Liquid waste, solid residues, packaging materials. Disposal technique The release of phosphates to wastewater is highly regulated. The residue of the containers or the used container itself should be disposed in accordance with local requirements. See Section 13 of the SDS for more information. Not determined. Fraction released to environment during waste treatment 5. Prediction of exposure and comparison of predicted exposure with DNELs (Risk Characterisation) 5.1. Human exposure Exposure estimation tool(s) Workers (oral) Workers (inhalation) DNEL: Worker, longterm, systemic, inhalation: 3 44.08 mg/m General dust exposure limit: 10 mg/m3 ECETOC TRA (2010). MEASE(EBRC, Eurometaux, 2010): Used to assess exposure to inorganic solutions and handling of solid inorganics (PROC 26). The activities associated with the drilling fluid applications will not result in oral exposure of workers to TKPP. It is also considered that workplace exposure limits for dust are applicable to this substance in the countries in which the substance is manufactured and used. Therefore, the exposure estimates will also be compared against a relevant general dust limit for an inhalable fraction of 10 mg/m3 as described by the occupational exposure limits detailed in the Technical Rules for Hazardous Materials – TRGS 900, January 2006 (Germany).This applies to both industrial and professional use as although the two settings are not directly comparable, it may be prudent to assess both the DNEL and the industrial against the same values both for consistency and for worker safety. A comparison of both the DNEL and a dust limit will ensure that downstream users have enough information on the required RMMs to ensure safe use in line with regional or national limits. Various industrial activities associated with the drilling fluid applications may result in inhalation exposure of workers to TKPP. The risk characterisation ratios for these activities are given in the table below. Workers handling concentrated TKPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. The use of appropriate gloves and working suits is recommended. It is concluded that conditions can be defined under which the potential health risks from the use of TKPP in drilling fluid applications are adequately controlled. Exposure scenario: Risk characterisation for the industrial use of TKPP in drilling applications Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 74/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx Location: Indoors (In) / Outdoors (Out) Activity type: Industrial Conclusion RCR (OEL) Conclusion RCR (DNEL) Airborne TKPP conc. (mg/m3) Weight fraction (%) PRE Duration (hours) LEV Location Process Category Activities performed with TKPP solutions 3 4 5 8b 9 13 18 In No >4 No > 25 0.01 0.01 Risk controlled 0.001 Out* 30% >4 No > 25 0.007 0.007 Risk controlled 0.0007 In No >4 No > 25 0.05 0.05 Risk controlled 0.005 Out* 30% >4 No > 25 0.035 0.035 Risk controlled 0.0035 In No >4 No > 25 0.05 0.05 Risk controlled 0.005 Out* 30% >4 No > 25 0.035 0.035 Risk controlled 0.0035 In No >4 No > 25 0.01 0.01 Risk controlled 0.001 Out* 30% >4 No > 25 0.007 0.007 Risk controlled 0.0007 In No >4 No > 25 0.01 0.01 Risk controlled 0.001 Out* 30% >4 No > 25 0.007 0.007 Risk controlled 0.0007 In No >4 No > 25 0.01 0.01 Risk controlled 0.001 Out* 30% >4 No > 25 0.007 0.007 Risk controlled 0.0007 In No >4 No > 25 0.10 0.10 Risk controlled 0.01 Out* 30% >4 No > 25 0.07 0.07 Risk controlled 0.007 In No >4 No > 25 0.05 0.05 Risk controlled 0.005 0.035 Risk controlled 0.0035 19 Out* 30% > 4 No > 25 0.035 Activities performed with solids of low dustiness 3 4 5 8b 9 Revision date: X In No >4 No 100 0.10 0.0023 Risk controlled 0.01 Out 30% >4 No 100 0.07 0.0016 Risk controlled 0.007 In No >4 No 100 0.50 0.0113 Risk controlled 0.05 Out 30% >4 No 100 0.35 0.0079 Risk controlled 0.035 In No >4 No 100 0.50 0.0113 Risk controlled 0.05 Out 30% >4 No 100 0.35 0.0079 Risk controlled 0.035 In No >4 No 100 0.10 0.0023 Risk controlled 0.01 Out 30% >4 No 100 0.07 0.0016 Risk controlled 0.007 In No >4 No 100 0.10 0.0023 Risk controlled 0.01 Out 30% >4 No 100 0.07 0.0016 Risk controlled 0.007 Version: XX NB. Please read the NOTICE on the front page Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Page 75/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate 13 18 19 26 3 4 5 8b Date of issue: xxx In No >4 No 100 0.10 0.0023 Risk controlled 0.01 Out 30% >4 No 100 0.07 0.0016 Risk controlled 0.007 In No >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 0.70 0.0159 Risk controlled 0.07 In No >4 No 100 0.50 0.0113 Risk controlled 0.05 Out 30% >4 No 100 0.35 0.0079 Risk controlled 0.035 In No >4 No 100 1.50 0.0340 Risk controlled 0.15 Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Out* 30% > 4 No 100 1.05 0.0238 Risk controlled Activities performed with solids of medium dustiness 0.105 Risk controlled In No >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 0.70 0.0159 Risk controlled 0.07 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 0.70 0.0159 Risk controlled 0.07 In No >4 No 100 20.00 0.4537 Risk controlled 2 In 95% >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 14.00 0.3176 Risk controlled 1.4 Out 30% >4 90% 100 1.40 0.0318 Risk controlled 0.14 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.5 0.0794 Risk controlled 0.35 In No >4 No 100 4.00 0.0907 Risk controlled 0.4 Out* No In No >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 0.70 0.0159 Risk controlled 0.07 9 13 18 19 26 3 Revision date: X > 4 No 100 2.80 0.0635 Risk controlled Activities performed with solids of high dustiness Version: XX NB. Please read the NOTICE on the front page 0.28 Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Page 76/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate 4- 5 8b 9 13 18 19 26 Date of issue: xxx In No >4 No 100 25.00 0.5672 Risk controlled 2.5 In 90% >4 No 100 2.50 0.0567 Risk controlled 0.25 Out 30% >4 No 100 17.50 0.3970 Risk controlled 1.75 Out 30% >4 90% 100 1.75 0.0397 Risk controlled 0.175 In No >4 No 100 25.00 0.5672 Risk controlled 2.5 In 90% >4 No 100 2.50 0.0567 Risk controlled 0.25 Out 30% >4 No 100 17.50 0.3970 Risk controlled 1.75 Out 30% >4 90% 100 1.75 0.0397 Risk controlled 0.175 In No >4 No 100 25.00 0.5672 Risk controlled 2.5 In 95% >4 No 100 1.25 0.0284 Risk controlled 0.125 Out 30% >4 No 100 17.50 0.3970 Risk controlled 1.75 Out 30% >4 90% 100 1.75 0.0397 Risk controlled 0.175 In No >4 No 100 20.00 0.4537 Risk controlled 2 In 90% >4 No 100 2.00 0.0454 Risk controlled 0.2 Out 30% >4 No 100 14.00 0.3176 Risk controlled 1.4 Out 30% >4 90% 100 1.40 0.0318 Risk controlled 0.14 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled RMMs required 0.35 In No >4 No 100 50.00 1.1343 In 95% >4 No 100 2.50 0.0567 Risk controlled 0.25 Out 30% >4 No 100 35.00 0.7940 Risk controlled 3.5 Out 30% >4 90% 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 25.00 0.5672 Risk controlled 2.5 In 90% >4 No 100 2.50 0.0567 Risk controlled 0.25 Out 30% >4 No 100 17.50 0.3970 Risk controlled 1.75 Out 30% >4 90% 100 1.75 0.0397 Risk controlled 0.175 In No >4 No 100 10.00 0.2269 Risk controlled 1 In 75% >4 No 100 2.50 0.0567 Risk controlled 0.25 Out* 30% >4 No 100 7.00 0.1588 Risk controlled 0.7 5 RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled Risk controlled Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled RMMs required Risk controlled Risk controlled *Outdoor exposure of industrial workers assumed to be reduced by 30% to give consistency with ECETOC calculations for solids. Workers Revision date: X No systemic toxicity effects are expected due to the inorganic nature of the substance Version: XX NB. Please read the NOTICE on the front page Page 77/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx (dermal) however local effects may occur but these effects will not be dose-dependent but will depend on the concentration of the substance present in the mixture/solution used in a specific application. Indirect exposure via the environment No indirect exposure of humans via the environment is expected for TKPP, as the substance can be effectively removed from the wastewater. Thus, no assessment of indirect exposure of humans via the environment is performed. Consumer exposure No direct consumer exposure is anticipated with the use of TKPP in drilling fluid applications. It is concluded that the use of TKPP in drilling fluid applications is of no risk for the general public. 5.2. Environmental exposure (qualitative assessment) Environmental release TKPP is listed in the OSPAR list of substances/preparations used and discharged offshore which are considered to pose little or no risk to the environment (PLONOR). Further, national regulations are available to regulate the waste management from offshore and mining industry. The use of TKPP can potentially result in aquatic emissions and locally increase the 3phosphate (PO4 ) concentration. Phosphates reaching surface water increase the phosphorus content in the water body which may cause eutrophication and water quality deterioration. Waste water treatment plants (WWTP) Phosphorus should be removed from industrial wastewater before it is released to the environment. This can be done by chemical treatment (by precipitation with the help of aluminium or iron addition) or biological treatments. A high degree of removal can be reliably achieved by the available phosphorus removal techniques. Site-specific conditions such as flow rate of the receiving surface water body and phosphorus concentration in the receiving surface water body should be taken into account when implementing an appropriate wastewater treatment. Council Directive 96/61/EC concerning integrated pollution prevention and control and national regulations concerning phosphates in industrial wastewater have to be followed to minimise the risk of eutrophication due to phosphate releases. Aquatic pelagic compartment No direct acute or long-term adverse effects on aqueous or terrestrial organisms are anticipated with orthophosphates in the environment. Sediments Soil and groundwater No direct acute or long-term adverse effects on aqueous or sediment organisms are anticipated with orthophosphates in the environment. No direct acute or long-term adverse effects on terrestrial organisms are anticipated with orthophosphates in the environment. Atmospheric compartment The use of TKPP in drilling applications is not considered to pose a risk to the atmospheric compartment. Secondary poisoning Bioaccumulation in organisms is not relevant for inorganic phosphates. ES9: Professional and consumer use of TKPP and products and materials containing TKPP in ceramic manufacture and construction and building work 1. Short title of exposure scenario 9 Use of TKPP and products and materials containing TKPP in ceramic manufacture and construction and building work Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 78/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx 2. Description of activities and processes covered in the exposure scenario Sector of use (SU) SU 19: Building and construction work SU 21: Consumer uses: private households SU 22:Professional uses Product PC 0: Other: construction materials category (PC) PC 1: Adhesives, sealants PC 9a: Coatings and paints, thinners, paint removers PC 9b: Fillers, putties, plasters, modelling clay PC 18: Ink and toners PC 30: Photo-chemicals PC 31: Polishes and wax blends PC 32: Polymer preparations and compounds Process PROC 4: Use in batch and other process (synthesis) where opportunity for exposure arises category PROC 5: Mixing or blending in batch processes (multistage and/or significant contact) (PROC) PROC 8a: Transfer of chemicals from/to vessels/ large containers at non dedicated facilities PROC 9: Transfer of substance or preparation into small containers (dedicated filling line, including weighing) PROC 10: Roller application or brushing PROC 11: Non industrial spraying PROC 13: Treatment of articles by dipping and pouring PROC 19: Hand-mixing with intimate contact and only PPE available. PROC 23: Open processing and transfer of minerals at elevated temperature PROC 24: High (mechanical) energy work-up of substances bound in materials and/or articles PROC 26: Handling of solid inorganic substances at ambient temperature Article AC 0: Other: Constructional articles and building material for indoor use: wall construction category (AC) material ceramic, metal, plastic and wood construction material, insulating material Environmental ERC 8a: Wide dispersive indoor use of processing aids in open systems release ERC 8b: Wide dispersive indoor use of reactive substances in open systems category ERC 8c: Wide dispersive indoor use of resulting in inclusion into or onto a matrix (ERC) ERC 8d: Wide dispersive outdoor use of processing aids in open systems ERC 8e: Wide dispersive outdoor use of reactive substances in open systems ERC 10a: Wide dispersive outdoor use of long-life articles and materials with low release 3. Operational conditions 3. 1 Operational conditions related with frequency and quantities of use Duration of exposure at workplace: Frequency of exposure at workplace: Revision date: X No information about frequency and duration of the various tasks is available. In the firsttier assessment of exposure a frequency of once a day and an exposure duration of 8 hours was considered. A single worker may be exposed on 220 days per year. No information about the concentration of the substance in dilute and concentrated solutions or in solids is available. The CEPE has developed exposure scenarios for consumer use of coatings in the context of the REACH regulation (CEPE 2009). These scenarios indicate a maximum duration of use ranging from 4 to 8 hours. No use frequency is given in the CEPE scenarios. The frequency of paint use by consumers is between 1 to 3 times a year depending on the type of paint used; the amount of paint used per application ranges from approximately 1 to 1.3 kg (RIVM 2007b). No information about the concentration of TKPP in paints for consumer use is given. In the first-tier assessment of exposure the concentration of the substance in paints is set to 10 %. Paints containing TKPP are used by consumers in various ways. The ready-to-use preparations can be purchased in retail shops. Hand mixing of other components into the paint before use may occur. The paint mixture has to be transferred from the transport, storage or mixing vessels to smaller containers or the spray systems. Paints are brushed onto surfaces or sprayed using medium to high pressure systems in private indoor or outdoor settings. Spray painting is performed manually in open processes. Painted surfaces are air-dried. Extensive manual cleaning of the equipment after use may be necessary. Version: XX NB. Please read the NOTICE on the front page Page 79/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Annual amount used per site: Date of issue: xxx The daily and annual amount/emission per site is not considered to be the main determinant for environmental exposure. 3.2 Operational conditions related with substance/ product Physical state Solid / Liquid Concentration of substance in mixture In the first-tier assessment of exposure worst-case assumptrion were made with regards to the composition of materials containing TKPP. The concentration of TKPP in undiluted liquid mixtures was > 25 % w/w. The concentration of solid TKPP delivered to professional and private users was 100% w/w and the concentration in cements, plasters and other solid products for consumer use was 10% w/w. The amounts of products and materials used per event may vary considerably ranging from a few grams to several hundred kilograms of material per event. The CEPE has developed exposure scenarios for consumer use of coatings in the context of the REACH regulation (CEPE 2009). These scenarios indicate a maximum duration of use ranging from 4 to 8 hours. No use frequency is given in the CEPE scenarios. The frequency of paint use by consumers is between 1 to 3 times a year depending on the type of paint used; the amount of paint used per application ranges from approximately 1 to 1.3 kg (RIVM 2007b). No information about the concentration of TKPP in paints for consumer use is given. In the first-tier assessment of exposure the concentration of the substance in paints is set to 10 %. Paints containing TKPP are used by consumers in various ways. The ready-to-use preparations can be purchased in retail shops. Hand mixing of other components into the paint before use may occur. The paint mixture has to be transferred from the transport, storage or mixing vessels to smaller containers or the spray systems. Paints are brushed onto surfaces or sprayed using medium to high pressure systems in private indoor or outdoor settings. Spray painting is performed manually in open processes. Painted surfaces are air-dried. Extensive manual cleaning of the equipment after use may be necessary. 3.3 Other relevant operational conditions Not applicable. 4. Risk Management Measures 4.1 RMMs related to workers Organisational measures The employer must ensure that the required PPE is available and used according to instructions (provide training if necessary). PPE are required when breaching the system or handling the pure substance and concentrated solutions. Eye wash stations should be available in case of accidental contact. Technical measures Respiratory protection Revision date: X Store in cool, dry, clean, well ventilate areas. (Good practice). Professionals wear appropriate personal protection equipment, such as goggles, gloves and working suits, when handling solutions or materials, cements and plasters containing TKPP Breathing masks may be used during transfer and mixing of solid preparations to reduce the inhalation of dusts. Respiratory protection: Respiratory protection is required when workers are exposure to dusts, if LEV with an efficiency of ≥90% is not available. Exposure to dusts from the handling of solid materials should be reduced by the use of local exhaust ventilation (efficiency of at least 90%, please see below for specific requirements). If outdoors PRE may be required. NOTE. For certain processes an efficiency of ≥95% is assumed. Please see below Version: XX NB. Please read the NOTICE on the front page Page 80/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Hand protection Eye protection Date of issue: xxx exposure summary for details It is assumed that professional locations may not have sufficient local exhaust ventilation, therefore , If local exhaust ventilation is not available then it will be necessary to use personal respiratory protection that is compliant with EN141 or EN 405 and has a sufficient efficiency (see table below for assumed APF and/or efficiency values). Hand protection is recommended: impervious chemical resistant protective gloves. Material: Material of gloves: Butyl rubber, BR. Fluorocarbon rubber (Viton). Nitrile rubber, NBR. Natural rubber, NR. Chloroprene rubber, CR. Neoprene gloves. Workers handling concentrated TKPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. Goggles or face protection shield should be consistent with EN 166 or equivalent. Skin and body protection Wearing of suitable protective clothing and rubber boots is recommended. Hygiene measures Keep away from foodstuffs, drinks and tobacco. Wash hands before breaks and at end of work. Keep work clothes separate. 4.2 RMMs related to consumers It is assumed that consumers will not wear PPE. However, eye protection and hand protection is recommended. 4.3 RMMs related to the environment Organisational measures Emissions to the environment must meet the requirements of Council Directive 96/61/EC and National Regulations concerning phosphate in industrial wastewater. Abatement measures related with wastewater Phosphate can be precipitated from the wastewater by addition of metal ions. Abatement measures waste air and solid waste Solid and liquid waste has to be incinerated or appropriately disposed of as chemical waste. 4.4 Waste related measures Type of waste Liquid waste, solid residues, packaging materials. Disposal technique The release of phosphates to wastewater is highly regulated. The residue of the containers or the used container itself should be disposed in accordance with local requirements. See Section 13 of the SDS for more information. Not determined. Fraction released to environment during waste treatment 5. Prediction of exposure and comparison of predicted exposure with DNELs (Risk Characterisation) 5.1. Human exposure Exposure estimation tool(s) Workers (oral) Workers: ECETOC TRA (2010). MEASE(EBRC, Eurometaux, 2010): Used to assess exposure to inorganic solutions and handling of solid inorganics (PROC 26). Consumers: ConsExpo (RIVM 2006) The use of TKPP in products and materials in construction and building work will not notably contribute to the oral intake of phosphates. Workers It is also considered that workplace exposure limits for dust are applicable to this substance Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 81/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate (inhalation) DNEL: Worker, longterm, systemic, inhalation: 3 44.08 mg/m General dust exposure limit: 10 mg/m3 Date of issue: xxx in the countries in which the substance is manufactured and used. Therefore, the exposure estimates will also be compared against a relevant general dust limit for an inhalable fraction of 10 mg/m3 as described by the occupational exposure limits detailed in the Technical Rules for Hazardous Materials – TRGS 900, January 2006 (Germany).This applies to both industrial and professional use as although the two settings are not directly comparable, it may be prudent to assess both the DNEL and the industrial against the same values both for consistency and for worker safety. A comparison of both the DNEL and a dust limit will ensure that downstream users have enough information on the required RMMs to ensure safe use in line with regional or national limits. Various professional activities associated with the use of products and materials containing TKPP in construction and building work may result in inhalation exposure of workers to TKPP. The risk characterisation ratios for these activities are given in the table below. Workers handling concentrated TKPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. The use of appropriate gloves and working suits is recommended. It is concluded that conditions can be defined under which the potential health risks from the use of products and materials containing TKPP in construction and building work are adequately controlled. Exposure scenario: Risk characterisation for the professional use of TKPP in products and materials in the construction and building industries. Location: Indoors (In) / Outdoors (Out) Activity type: Professional Conclusion RCR (OEL) Conclusion RCR (DNEL) Airborne TKPP conc. (mg/m3) Weight fraction (%) PRE Duration (hours) LEV Location Process Category Activities performed with TKPP solutions In No >4 No > 25 0.10 0.0023 Risk controlled 0.01 Out 30% >4 No > 25 0.071 0.0016 Risk controlled 0.0071 In No >4 No > 25 0.10 0.0023 Risk controlled 0.01 Out 30% >4 No > 25 0.071 0.0016 Risk controlled 0.0071 In No >4 No > 25 0.05 0.0011 Risk controlled 0.005 Out 30% >4 No > 25 0.036 0.0008 Risk controlled 0.0036 In No >4 No > 25 0.05 0.0011 Risk controlled 0.005 Out 30% >4 No > 25 0.036 0.0008 Risk controlled 0.0036 In No >4 No > 25 0.05 0.0011 Risk controlled 0.005 Out 30% >4 No > 25 0.036 0.0008 Risk controlled 0.0036 In No >4 No > 25 20.00 0.4537 Risk controlled 2 In 80% >4 No > 25 4.00 0.0907 Risk controlled 0.4 Out 30% >4 No > 25 14.25 0.3233 Risk controlled 1.425 11 Ou 30% >4 75% > 25 3.56 0.0808 Risk controlled 0.356 In Out No 30% >4 >4 No No > 25 > 25 0.05 13 0.0011 0.0008 Risk controlled Risk controlled 0.005 0.0036 4 5 8a 9 10 Revision date: X Version: XX NB. Please read the NOTICE on the front page 0.036 Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled RMMs required Risk controlled Risk controlled Risk Page 82/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Risk controlled 0.005 No > 25 0.05 0.0011 Risk controlled Activities performed with solids of low dustiness 0.005 No >4 Out 30% >4 In No >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 0.70 0.0159 Risk controlled 0.07 In No >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 0.70 0.0159 Risk controlled 0.07 In No >4 No 100 0.50 0.0113 Risk controlled 0.05 Out 30% >4 No 100 0.35 0.0079 Risk controlled 0.035 In No >4 No 100 0.50 0.0113 Risk controlled 0.05 Out 30% >4 No 100 0.35 0.0079 Risk controlled 0.035 In No >4 No 100 0.50 0.0113 Risk controlled 0.05 Out 30% >4 No 100 0.35 0.0079 Risk controlled 0.035 In No >4 No 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 0.70 0.0159 Risk controlled 0.07 In No >4 No 100 0.50 0.0113 Risk controlled 0.05 Out 30% >4 No 100 0.35 0.0079 Risk controlled 0.035 In No >4 No 100 0.50 0.0113 Risk controlled 0.05 Out 30% >4 No 100 0.35 0.0079 Risk controlled 0.035 In No >4 No 100 3.00 0.0681 Risk controlled 0.3 Out 30% >4 No 100 2.10 0.0476 Risk controlled 0.21 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 20.00 0.4537 Risk controlled 2 In 80% >4 No 100 4.00 0.0907 Risk controlled 0.4 In No >4 90% 100 2.00 0.0454 Risk controlled 0.2 Out 30% >4 No 100 14.00 0.3176 Risk controlled 1.4 Out 30% >4 90% 100 1.40 0.0318 Risk controlled 0.14 24a Low Fugacity In No >4 No 100 3.00 0.0681 Risk controlled 0.3 Out 30% >4 No 100 2.10 0.0476 Risk controlled 0.21 24b Med Fugacity In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 4 5 8a 9 10 11 13 19 23a pt<mp Low Fugacity 23b pt ≈ mp - Med Fugacity 23c pt > mp - High Fugacity No > 25 0.05 In 19 Revision date: X Date of issue: xxx Version: XX NB. Please read the NOTICE on the front page 0.0011 controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Page 83/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate 24c High Fugacity 26 4 5 8a 9 10 11 13 19 23a pt<mp Low Fugacity 23b pt ≈ mp - Med Fugacity 23c pt > mp - High Fugacity Revision date: X Date of issue: xxx In No >4 No 100 20.00 0.4537 Risk controlled 2 In 75% >4 No 100 5.00 0.1134 Risk controlled 0.5 In No >4 90% 100 2.00 0.0454 Risk controlled 0.2 Out 30% >4 No 100 14.00 0.3176 Risk controlled 1.4 Out 30% >4 90% 100 1.40 0.0318 Risk controlled 0.14 In No >4 No 100 3.00 0.0681 Risk controlled 0.3 Out 30% >4 No 100 2.14 0.0485 Risk controlled Activities performed with solids of medium dustiness In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 20.00 0.4537 Risk controlled 2 In 80% >4 No 100 4.00 0.0907 Risk controlled 0.4 In No >4 90% 100 2.00 0.0454 Risk controlled 0.2 Out 30% >4 No 100 14.00 0.3176 Risk controlled 1.4 Ou 30% >4 90% 100 1.40 0.0318 Risk controlled 0.14 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 3.00 0.0681 Risk controlled 0.3 Out 30% >4 No 100 2.10 0.0476 Risk controlled 0.21 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 20.00 0.4537 Risk controlled 2 In 80% >4 No 100 4.00 0.0907 Risk controlled 0.4 Version: XX NB. Please read the NOTICE on the front page 0.214 RMMs required Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Page 84/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate In No >4 90% 100 2.00 0.0454 Risk controlled 0.2 Out 30% >4 No 100 14.00 0.3176 Risk controlled 1.4 Out 30% >4 90% 100 1.40 0.0318 Risk controlled 0.14 24a Low Fugacity In No >4 No 100 3.00 0.0681 Risk controlled 0.3 Out 30% >4 No 100 2.10 0.0476 Risk controlled 0.21 24b Med Fugacity In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 20.00 0.4537 Risk controlled 2 In 75% >4 No 100 5.00 0.1134 Risk controlled 0.5 In No >4 90% 100 2.00 0.0454 Risk controlled 0.2 Out 30% >4 No 100 14.00 0.3176 Risk controlled 1.4 Out 30% >4 90% 100 1.40 0.0318 Risk controlled 0.14 In No >4 No 100 8.00 0.1815 Risk controlled 0.8 Out 30% >4 No 100 5.70 0.1293 Risk controlled Activities performed with solids of high dustiness In No >4 No 100 50.00 1.1343 RMMs required 5 In 80% >4 No 100 10.00 0.2269 Risk controlled 1 In 80% 1 to 4 No 100 6.00 0.1361 Risk controlled 0.6 In No >4 90% 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 35.00 0.7940 Risk controlled 3.5 Out 30% >4 90% 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 50.00 1.1343 RMMs required 5 In 80% >4 No 100 10.00 0.2269 Risk controlled 1 In 80% 1 to 4 No 100 6.00 0.1361 Risk controlled 0.6 In No >4 90% 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 35.00 0.7940 Risk controlled 3.5 Out 30% >4 90% 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 50.00 1.1343 In 80% >4 No 100 10.00 0.2269 Risk controlled 1 In 80% 1 to 4 No 100 6.00 0.1361 Risk controlled 0.6 In No >4 90% 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 35.00 0.7940 Risk controlled 3.5 8a Out 30% >4 90% 100 3.50 0.0794 Risk controlled 0.35 9 In No >4 No 100 20.00 0.4537 Risk controlled 2 24c High Fugacity 26 4 5 Revision date: X Date of issue: xxx Version: XX NB. Please read the NOTICE on the front page 0.57 5 Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled RMMs required RMMs required Risk controlled Risk controlled RMMs required Risk controlled RMMs required RMMs required Risk controlled Risk controlled RMMs required Risk controlled RMMs required RMMs required Risk controlled Risk controlled RMMs required Risk controlled RMMs required Page 85/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate 10 11 13 19 23a pt<mp Low Fugacity 23b pt ≈ mp - Med Fugacity 23c pt > mp - High Fugacity 24a Revision date: X Date of issue: xxx In 80% >4 No 100 4.00 0.0907 Risk controlled 0.4 In No >4 90% 100 2.00 0.0454 Risk controlled 0.2 Out 30% >4 No 100 14.00 0.3176 Risk controlled 1.4 Out 30% >4 90% 100 1.40 0.0318 Risk controlled 0.14 In No >4 No 100 10.00 0.2269 Risk controlled 1 In 80% >4 No 100 2.00 0.0454 Risk controlled 0.2 In No >4 90% 100 1.00 0.0227 Risk controlled 0.1 Out 30% >4 No 100 7.00 0.1588 Risk controlled 0.7 In No >4 No 100 200.00 4.5372 In 80% >4 No 100 40.00 0.9074 Risk controlled 4 In 80% 0.25 to 1 No 100 8.00 0.1815 Risk controlled 0.8 In No >4 90% 100 20.00 0.4537 Risk controlled 2 In No 0.25 to 1 90% 100 4.00 0.0907 Risk controlled 0.4 In 80% >4 90% 100 4.00 0.0907 Risk controlled 0.4 Out 30% >4 No 100 140.00 3.1760 Out 30% >4 95% 100 7.00 0.1588 Risk controlled 0.7 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 50.00 1.1343 In 80% >4 No 100 10.00 0.2269 Risk controlled 1 In 80% 1 to 4 No 100 3.00 0.0681 Risk controlled 0.3 In No >4 90% 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 35.00 0.7940 Risk controlled 3.5 Out 30% >4 90% 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 3.00 0.0681 Risk controlled 0.3 Out 30% >4 No 100 2.10 0.0476 Risk controlled 0.21 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 20.00 0.4537 Risk controlled 2 In 80% >4 No 100 4.00 0.0907 Risk controlled 0.4 In No >4 90% 100 2.00 0.0454 Risk controlled 0.2 Out 30% >4 No 100 14.00 0.3176 Risk controlled 1.4 Out In 30% No >4 >4 90% No 100 100 1.40 3.00 0.0318 0.0681 Risk controlled Risk controlled 0.14 0.3 Version: XX NB. Please read the NOTICE on the front page 20 14 5 Risk controlled Risk controlled RMMs required Risk controlled RMMs required Risk controlled Risk controlled Risk controlled RMMs required RMMs required Risk controlled RMMs required Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled RMMs required RMMs required Risk controlled Risk controlled RMMs required Risk controlled Risk controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled RMMs required Risk controlled Risk Page 86/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx Low Fugacity 24b Med Fugacity 24c High Fugacity 26 Out 30% >4 No 100 2.10 0.0476 Risk controlled 0.21 In No >4 No 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 3.50 0.0794 Risk controlled 0.35 In No >4 No 100 20.00 0.4537 Risk controlled 2 In 75% >4 No 100 5.00 0.1134 Risk controlled 0.5 In No >4 90% 100 2.00 0.0454 Risk controlled 0.2 Out 30% >4 No 100 14.00 0.3176 Risk controlled 1.4 Out 30% >4 90% 100 1.40 0.0318 Risk controlled 0.14 In No >4 No 100 20.00 0.4537 Risk controlled 2 In 80% >4 No 100 4.00 0.0907 Risk controlled 0.4 In No >4 75% 100 5.00 0.1134 Risk controlled 0.5 Out 30% >4 No 100 14.25 0.3233 Risk controlled 1.425 Out 30% >4 75% 100 3.56 0.0808 Risk controlled 0.356 controlled Risk controlled Risk controlled Risk controlled RMMs required Risk controlled Risk controlled RMMs required Risk controlled RMMs required Risk controlled Risk controlled RMMs required Risk controlled * Outdoor exposure of industrial workers assumed to be reduced by 30% to give consistency with ECETOC calculations for solids Workers (dermal) No systemic toxicity effects are expected due to the inorganic nature of the substance however local effects may occur but these effects will not be dose-dependent but will depend on the concentration of the substance present in the mixture/solution used in a specific application. Indirect exposure via the environment No indirect exposure of humans via the environment is expected for TKPP, as the substance can be effectively removed from the wastewater. Thus, no assessment of indirect exposure of humans via the environment is performed. Consumer exposure Private users of products and materials used for construction and building work and containing TKPP and users of paints containing TKPP may be exposed to the substance by inhalation. The risk characterisation ratios obtained for different types of paints applied by rolling, brushing or spraying are given in the tables below. It is concluded that the conditions of consumer use of products and materials containing TKPP for private construction and building work are such that the potential human health risks are adequately controlled. DNEL: General Population, long-term, systemic, inhalation: 10.87 mg/m3 Revision date: X Risk characterisation for consumer use of powdery building materials and paints Parameter High-solid WaterSolventWall Spray paint (unit) based based 0.00019 1.82E-05 0.000112 4.73E-05 0.521 Mean concentration of a day of exposure (mg/m3) 1.75E-05 1.67E-06 1.03E-05 4.35E-06 0.048 RCR inhalation Risk Risk Risk Risk Risk adequately adequately adequately adequately adequately Conclusion controlled controlled controlled controlled controlled Version: XX NB. Please read the NOTICE on the front page Pneumatic spraying 0.0117 1.08E-03 Risk adequately controlled Page 87/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx 5.2. Environmental exposure (qualitative assessment) Environmental release The use of TKPP can potentially result in aquatic emissions and locally increase the 3phosphate (PO4 ) concentration. Phosphates reaching surface water increase the phosphorus content in the water body which may cause eutrophication and water quality deterioration. Waste water treatment plants (WWTP) Phosphorus should be removed from industrial wastewater before it is released to the environment. This can be done by chemical treatment (by precipitation with the help of aluminium or iron addition) or biological treatments. A high degree of removal can be reliably achieved by the available phosphorus removal techniques. Site-specific conditions such as flow rate of the receiving surface water body and phosphorus concentration in the receiving surface water body should be taken into account when implementing an appropriate wastewater treatment. Council Directive 96/61/EC concerning integrated pollution prevention and control and national regulations concerning phosphates in industrial wastewater have to be followed to minimise the risk of eutrophication due to phosphate releases. Aquatic pelagic compartment No direct acute or long-term adverse effects on aqueous or terrestrial organisms are anticipated with orthophosphates in the environment. Sediments Soil and groundwater No direct acute or long-term adverse effects on aqueous or sediment organisms are anticipated with orthophosphates in the environment. No direct acute or long-term adverse effects on terrestrial organisms are anticipated with orthophosphates in the environment. Atmospheric compartment The use of TKPP and products and materials containing TKPP is not considered to pose a risk to the atmospheric compartment. Secondary poisoning Bioaccumulation in organisms is not relevant for inorganic phosphates. ES10: Professional and consumer use of TKPP and products containing TKPP in fertiliser products 1. Short title of exposure scenario 10 Professional and consumer use of TKPP and products containing TKPP in fertiliser products 2. Description of activities and processes covered in the exposure scenario Sector of use (SU) Product category (PC) Process category (PROC) SU 1: Agriculture, forestry, fishery SU 21: Consumer uses: private households SU 22: Professional Uses PC 12: Fertilizers PROC 8a: Transfer of chemicals from/to vessels/ large containers at non dedicated facilities PROC 8b: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities PROC 9: Transfer of substance or preparation into small containers (dedicated filling line, including weighing) PROC 11: Non industrial spraying PROC 19: Hand-mixing with intimate contact and only PPE available. Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 88/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Article category (AC) Environment al release category (ERC) Date of issue: xxx Not applicable ERC 8a: Wide dispersive indoor use of processing aids in open systems ERC 8c: Wide dispersive indoor use of resulting in inclusion into or onto a matrix ERC 8d: Wide dispersive outdoor use of processing aids in open systems ERC 8e: Wide dispersive outdoor use of reactive substances in open systems ERC 8f: Wide dispersive outdoor use resulting in inclusion into or onto a matrix 3. Operational conditions 3. 1 Operational conditions related with frequency and quantities of use Duration of exposure at workplace: No information about frequency and duration of the various tasks is available. In the first-tier assessment of exposure a frequency of once a day and an exposure duration of 8 hours was considered. A single worker may be exposed on 220 days per year. Frequency of exposure at workplace: Annual amount used per site: The daily and annual amount/emission per site is not considered to be the main determinant for environmental exposure. 3.2 Operational conditions related with substance/ product Physical state Solid / Liquid Concentratio n of substance in mixture No information about the concentration of TKPP in liquid or solid fertilisers is available and a concentration of 100% w/w for the undiluted product and > 25% w/w for the diluted product was considered in the first-tier exposure assessment and worst-case. 3.3 Other relevant operational conditions Not applicable. 4. Risk Management Measures 4.1 RMMs related to workers Organisation al measures The employer must ensure that the required PPE is available and used according to instructions (provide training if necessary). PPE are required when breaching the system or handling the pure substance and concentrated solutions. Eye wash stations should be available in case of accidental contact. Technical measures Respiratory protection Store in cool, dry, clean, well ventilate areas. (Good practice). Local exhaust ventilation may be present. Professionals wear appropriate personal protection equipment, such as goggles, gloves and working suits, when handling solutions or materials, cements and plasters containing TKPP Breathing masks may be used during transfer and mixing of solid preparations to reduce the inhalation of dusts. Respiratory protection: Respiratory protection is required when workers are exposure to dusts, if LEV with an efficiency of ≥90% is not available. Exposure to dusts from the handling of solid materials should be reduced by the use of local exhaust ventilation (efficiency of at least 90%, please see below for specific requirements). If outdoors PRE may be required. NOTE. For certain processes an efficiency of ≥95% is assumed. Please see below exposure summary for details It is assumed that professional locations may not have sufficient local exhaust ventilation, therefore , If local exhaust ventilation is not available then it will be necessary to use Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 89/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Hand protection Eye protection Date of issue: xxx personal respiratory protection that is compliant with EN141 or EN 405 and has a sufficient efficiency (see table below for assumed APF and/or efficiency values). Hand protection is recommended: impervious chemical resistant protective gloves. Material: Material of gloves: Butyl rubber, BR. Fluorocarbon rubber (Viton). Nitrile rubber, NBR. Natural rubber, NR. Chloroprene rubber, CR. Neoprene gloves. Workers handling concentrated TKPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. Goggles or face protection shield should be consistent with EN 166 or equivalent. Skin and body protection Wearing of suitable protective clothing and rubber boots is recommended. Hygiene measures Keep away from foodstuffs, drinks and tobacco. Wash hands before breaks and at end of work. Keep work clothes separate. 4.2 RMMs related to consumers It is assumed that consumers will not wear PPE. However, eye protection and hand protection is recommended. 4.3 RMMs related to the environment Organisation al measures Not applicable Abatement measures related with wastewater Phosphates are generally retained on soil particles and except in exceptional circumstances will not leach through soils to ground or surface water as soluble ions. Loss to surface waters is thus usually related to surface run-off or erosion of soil particles, which carry attached phosphates. To avoid such effects, the following recommendations (Lory, 1999) should be followed: Abatement measures waste air and solid waste Apply phosphorus sources below the surface. Surface-apply phosphorus sources during periods of the year when runoff is unlikely. Surface-apply phosphorus sources only on fields with a low potential for runoff. Do not surface-apply phosphorus sources to frozen or snow-covered soils. Maintain buffer strips around water resources where no phosphorus is applied. Add alum or similar treatment to manure to reduce the availability of phosphorus. Solid and liquid waste has to be incinerated or appropriately disposed of as chemical waste. 4.3 Waste related measures Type of waste Liquid waste, solid residues, packaging materials. Disposal technique The release of phosphates to wastewater is highly regulated. The residue of the containers or the used container itself should be disposed in accordance with local requirements. See Section 13 of the SDS for more information. Not determined. Fraction released to environment during waste treatment 5. Prediction of exposure and comparison of predicted exposure with DNELs (Risk Characterisation) 5.1. Human exposure Exposure estimation Workers, TIER 1: ECETOC TRA (2010), MEASE(EBRC, Eurometaux, 2010): Used to assess exposure to inorganic solutions and handling of solid inorganics (PROC 26). [Results Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 90/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate tool(s) Workers (oral) Date of issue: xxx not summarised]. Workers, TIER 2: UK POEM Consumers: UK POEM and German model No oral exposure to TKPP is anticipated with the use of TKPP in fertilisers. It is also considered that workplace exposure limits for dust are applicable to this substance in the countries in which the substance is manufactured and used. Therefore, the exposure estimates will also be compared against a relevant general dust limit for an inhalable fraction of 10 mg/m3 as described by the occupational exposure limits detailed in the Technical Rules for Hazardous Materials – TRGS 900, January 2006 (Germany).This applies to both industrial and professional use as although the two settings are not directly comparable, it may be prudent to assess both the DNEL and the industrial against the same values both for consistency and for worker safety. A comparison of both the DNEL and a dust limit will ensure that downstream users have enough information on the required RMMs to ensure safe use in line with regional or national limits. Various professional activities associated with the use of fertilisers may result in inhalation exposure of workers to TKPP. The risk characterisation ratios for these activities are given in the table below. Workers handling concentrated TKPP solutions or pure, solid substances are obliged to wear chemical resistant safety goggles. The use of appropriate gloves and working suits is recommended. It is concluded that conditions can be defined under which the potential health risks from the professional use of fertilisers containing TKPP are adequately controlled. Workers (inhalation) DNEL: Worker, long-term, systemic, inhalation: 3 44.08 mg/m General dust exposure limit: 10 mg/m3 Hand-held Tractorsprayer (15 TractorTractormounted/ L tank): mounted/ mounted/ trailed hydraulic trailed boom trailed boom broadcast nozzles. sprayer: sprayer: air-assisted Outdoor, hydraulic rotary sprayer: 500 low level nozzles atomisers L/ha target Mixing and loading Solid, granular fertiliser Long-term exposure concentratio n of a.s. 1.08 RCR inhalation 0.108 Risk Conclusion controlled Long-term exposure concentratio n of a.s. 6.3 RCR inhalation 0.63 Risk Conclusion controlled Long-term exposure concentratio n of a.s. with PRE, 90% efficacy 0.63 RCR inhalation with PRE, 90% efficacy 0.063 Risk Conclusion controlled 0.03 Hand-held rotary atomiser equipment (2.5 L tank). Outdoor, low level target Hand-held rotary atomiser equipment (2.5 L tank). Outdoor, high level target Unit 0.04 0.04 mg/m 3 1.08 0.32 0.108 Risk controlled 0.032 0.003 Risk Risk controlled controlled Solid, powdery fertiliser 0.004 Risk controlled 0.004 Risk controlled 6.3 1.89 0.61 0.92 0.92 0.63 Risk controlled 0.189 Risk controlled 0.061 Risk controlled 0.092 Risk controlled 0.092 Risk controlled - mg/m 3 - 0.63 0.063 Risk controlled Spray Application Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 91/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Long-term exposure concentratio n of a.s. 0.06 inhalation RCR 0.006 Risk Conclusion controlled Date of issue: xxx mg/m 3 0.03 0.3 0.12 0.06 0.06 0.003 Risk controlled 0.03 Risk controlled 0.012 Risk controlled 0.006 Risk controlled 0.006 Risk controlled - Workers (dermal) No systemic toxicity effects are expected due to the inorganic nature of the substance however local effects may occur but these effects will not be dose-dependent but will depend on the concentration of the substance present in the mixture/solution used in a specific application. Indirect exposure via the environment No indirect exposure of humans via the environment is expected for TKPP, as the substance can be effectively removed from the wastewater. Thus, no assessment of indirect exposure of humans via the environment is performed. Consumer exposure Private users of fertilisers containing TKPP may be exposed to the substance by inhalation. The risk characterisation ratios obtained for different types of fertiliser applied are given in the table below. It is concluded that the conditions of consumer use of fertilisers containing TKPP are such that the potential human health risks are adequately controlled. DNEL: General Population, long-term, systemic, inhalation: 10.87 mg/m3 Private spraying of liquid fertilisers with home garden sprayer, 5 L-tank, low-level target Mixing and loading Solid, granular fertiliser 0.00015 1.38E-05 Risk adequately controlled Solid, powdery fertiliser 0.004 3.68E-04 Risk adequately controlled Spray Application 0.004 3.68E-04 Risk adequately controlled Long-term concentration of a.s. RCR inhalation Conclusion Long-term concentration of a.s. RCR inhalation Conclusion Long-term concentration of a.s. RCR inhalation Conclusion Unit mg/m3 - mg/m3 - mg/m3 - 5.2. Environmental exposure (qualitative assessment) Environment al release The use of TKPP can potentially result in aquatic emissions and locally increase the 3phosphate (PO4 ) concentration. Phosphates reaching surface water increase the phosphorus content in the water body which may cause eutrophication and water quality deterioration. Waste water treatment plants (WWTP) Phosphorus should be removed from industrial wastewater before it is released to the environment. This can be done by chemical treatment (by precipitation with the help of aluminium or iron addition) or biological treatments. A high degree of removal can be reliably achieved by the available phosphorus removal techniques. Site-specific conditions such as flow rate of the receiving surface water body and phosphorus concentration in the receiving surface water body should be taken into account when implementing an appropriate wastewater treatment. Council Directive 96/61/EC concerning integrated pollution prevention and control and national regulations concerning phosphates in industrial wastewater have to be followed to minimise the risk of eutrophication due to phosphate releases. Aquatic pelagic compartment No direct acute or long-term adverse effects on aqueous or terrestrial organisms are anticipated with orthophosphates in the environment. Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 92/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Sediments Date of issue: xxx Soil and groundwater No direct acute or long-term adverse effects on aqueous or sediment organisms are anticipated with orthophosphates in the environment. No direct acute or long-term adverse effects on terrestrial organisms are anticipated with orthophosphates in the environment. Atmospheric compartment The use of TKPP in fertilisers is not considered to pose a risk to the atmospheric compartment. Secondary poisoning Bioaccumulation in organisms is not relevant for inorganic phosphates. ES11: Consumer use of detergents 1. Short title of exposure scenario 11 Consumer use of detergents 2. Description of activities and processes covered in the exposure scenario Sector of use (SU) SU 21: Consumer uses: private households Product category (PC) PC 35: Washing and cleaning products (including solvent based products) Process category (PROC) Article category (AC) Not applicable Not applicable Environmental release category (ERC) ERC 8a: Wide dispersive indoor use of processing aids in open systems ERC 8b: Wide dispersive indoor use of reactive substances in open systems ERC 8d: Wide dispersive outdoor use of processing aids in open systems ERC 8e: Wide dispersive outdoor use of reactive substances in open systems 3. Operational conditions 3. 1 Operational conditions related with frequency and quantities of use Duration of exposure at workplace: Frequency of exposure at workplace: Annual amount used per site: Generic exposure scenarios for the consumer use of detergents were described (AISE 2009b). The ConsExpo tool contains representative exposure scenarios for a number of cleaning products (RIVM 2006). The daily and annual amount/emission per site is not considered to be the main determinant for environmental exposure. 3.2 Operational conditions related with substance/ product Physical state Solid / Liquid Concentration of substance in mixture Generic exposure scenarios for the consumer use of detergents were described (AISE 2009b). The ConsExpo tool contains representative exposure scenarios for a number of cleaning products (RIVM 2006). 3.3 Other relevant operational conditions Not applicable. 4. Risk Management Measures 4.1 RMMs related to consumers Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 93/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx Organisational measures Not applicable Technical measures Respiratory protection Consumer products should be intrinsically safe. Risk management measures relating to the use of TKPP in detergents should be conveyed on the package and no further consideration is required for the purpose of characterising the risk from this application. Not applicable Hand protection Not applicable Eye protection Not applicable Skin and body protection Not applicable Hygiene measures Not applicable 4.2 RMMs related to the environment Organisational measures Not applicable Abatement measures related with wastewater Detergents and cleaning products containing TKPP will finally be released to the sewage. Council directive 91/271/EEC concerning urban waste water requires phosphate removal from sewage, wherever receiving waters are potentially susceptible to eutrophication, in agglomerations >10,000 person equivalents. This requirement is confirmed by the EU Water Framework Directive 2000/60, which also further requires phosphate removal in smaller agglomerations where this is necessary to achieve water quality standards. Abatement measures waste air and solid waste Not applicable. 4.3 Waste related measures Type of waste Liquid waste, solid residues, packaging materials. Disposal technique The release of phosphates to wastewater is highly regulated. The residue of the containers or the used container itself should be disposed in accordance with local requirements. See Section 13 of the SDS for more information. Not determined. Fraction released to environment during waste treatment 5. Prediction of exposure and comparison of predicted exposure with DNELs (Risk Characterisation) 5.1. Human exposure Exposure estimation tool(s) ConsExpo (RIVM 2006) Workers (all routes) No worker exposure is anticipated with the consumer use of detergents. Indirect exposure via the environment No indirect exposure of humans via the environment is expected for TKPP, as the substance can be effectively removed from the wastewater. Thus, no assessment of indirect exposure of humans via the environment is performed. Consumer exposure Private users of detergents containing TKPP may be exposed to the substance by inhalation. The risk characterisation ratios obtained for different types of detergents and cleaners applied by rolling, brushing or Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 94/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate DNEL: General Population, long-term, systemic, inhalation: 10.87 mg/m3 Date of issue: xxx spraying are given in the table below. It is concluded that the conditions of consumer use of detergents containing TKPP are such that the potential human health risks are adequately controlled. Detergent: loading Detergent: use Mean concentration of a day of exposure (mg/m3) Inhalation RCR 4.67 x 10-9 Not applicable 4.3E-10 Conclusion Risk adequately controlled Not applicable Risk adequately controlled Liquid cleaner: mixing and loading 3.04 x 10-9 Liquid cleaner: spraying 2.8E-10 1.06E-06 Risk adequately controlled Risk adequately controlled 1.15 x 10-5 5.2. Environmental exposure (qualitative assessment) Environmental release Waste water treatment plants (WWTP) The use of TKPP can potentially result in aquatic emissions and locally 3increase the phosphate (PO4 ) concentration. Phosphates reaching surface water increase the phosphorus content in the water body which may cause eutrophication and water quality deterioration. Phosphorus should be removed from industrial wastewater before it is released to the environment. This can be done by chemical treatment (by precipitation with the help of aluminium or iron addition) or biological treatments. A high degree of removal can be reliably achieved by the available phosphorus removal techniques. Site-specific conditions such as flow rate of the receiving surface water body and phosphorus concentration in the receiving surface water body should be taken into account when implementing an appropriate wastewater treatment. Council Directive 96/61/EC concerning integrated pollution prevention and control and national regulations concerning phosphates in industrial wastewater have to be followed to minimise the risk of eutrophication due to phosphate releases. Aquatic pelagic compartment No direct acute or long-term adverse effects on aqueous or terrestrial organisms are anticipated with orthophosphates in the environment. Sediments No direct acute or long-term adverse effects on aqueous or sediment organisms are anticipated with orthophosphates in the environment. No direct acute or long-term adverse effects on terrestrial organisms are anticipated with orthophosphates in the environment. The use of TKPP in detergents is not considered to pose a risk to the atmospheric compartment. Soil and groundwater Atmospheric compartment Secondary poisoning Bioaccumulation in organisms is not relevant for inorganic phosphates. ES12: Consumer use of cosmetics, toothpaste and other products containing TKPP 1. Short title of exposure scenario 12 Consumer use of cosmetics, toothpaste and other products containing TKPP 2. Description of activities and processes covered in the exposure scenario Sector of use (SU) Revision date: X SU 21: Consumer uses: private households. Version: XX NB. Please read the NOTICE on the front page Page 95/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Date of issue: xxx Product category (PC) PC 28: Perfumes, fragrances PC 39: Cosmetics, personal care products Process category (PROC) Article category (AC) Not applicable. Not applicable Environmental release ERC 8a: Wide dispersive indoor use of processing aids in indoor systems. category (ERC) ERC 8b: wide dispersive indoor use of reactive substances in open systems. 3. Operational conditions The human exposure to TKPP from use of toothpaste is to be assessed under the Cosmetics Directive and is not investigated under the REACH regulation. Therefore operational conditions are not relevant for this scenario. 4. Risk Management Measures 4.1 RMMs related to consumers General advise Consumer products should be intrinsically safe. The human exposure to TKPP from use of toothpaste and other dental care products is to be assessed under the EU Cosmetics Directive and is not investigated under the REACH regulation. Risk management measures relating to the use of TSP in dental care products should be conveyed on the package and no further consideration is required. 4.2 RMMs related to the environment Organisational measures Not applicable Abatement measures related with wastewater Wastewater is treated via chemical/biological municipal wastewater treatment plants. Abatement measures waste air and solid waste Not applicable. 4.3 Waste related measures Type of waste Disposal technique Fraction released to environment during waste treatment After brushing teeth the mouth is flushed with water and the greatest portion of the toothpaste is disposed of via the sewer system. Sewage will be treated in municipal wastewater treatment plants. Minor amounts of products remain in the packages and will be disposed of via the regular household waste. Household waste may be deposited in a landfill. Not applicable. 5. Prediction of exposure and comparison of predicted exposure with DNELs (Risk Characterisation) 5.1. Human exposure Exposure estimation tool(s) Not applicable. Consumer exposure Consumer exposure to TKPP from the use of toothpaste is not assessed under REACH. The potential risk for consumers from the use of cosmetics and personal care products falls under the EU Cosmetics Directive. Worker exposure No occupational exposure to TKPP is expected from the use of toothpaste. Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 96/97 SAFETY DATA SHEET Tetrapotassium pyrophosphate Indirect exposure via the environment Date of issue: xxx No indirect exposure of humans via the environment is expected for TKPP, as the substance can be effectively removed from the wastewater. Thus, no assessment of indirect exposure of humans via the environment is performed. 5.2. Environmental exposure (qualitative assessment) 3- The use of TKPP can potentially result in aquatic emissions and locally increase the phosphate (PO4 ) concentration. Phosphates reaching surface water increase the phosphorus content in the water body which may cause eutrophication and water quality deterioration. Phosphorus should be removed from industrial wastewater before it is released to the environment. This can be done by chemical treatment (by precipitation with the help of aluminium or iron addition) or biological treatments. A high degree of removal can be reliably achieved by the available phosphorus removal techniques. Site-specific conditions such as flow rate of the receiving surface water body and phosphorus concentration in the receiving surface water body should be taken into account when implementing an appropriate wastewater treatment. Council Directive 96/61/EC concerning integrated pollution prevention and control and national regulations concerning phosphates in industrial wastewater have to be followed to minimise the risk of eutrophication due to phosphate releases. No direct acute or long-term adverse effects on aqueous or terrestrial organisms are anticipated with orthophosphates in the environment. Bioaccumulation in organisms is not relevant for inorganic phosphates. Revision date: X Version: XX NB. Please read the NOTICE on the front page Page 97/97