Safety Data Sheet in Accordance with Regulation (EC) No 1907

Transcription

Safety Data Sheet in Accordance with Regulation (EC) No 1907/2006
Page 1 of 5
Date of issue: 15.12.2011 Replaces Data Sheet of: 06.06.2011
"*" alterations as compared to previous version; n.ap. = not applicable; n.av. = not available
1
Identification of Substance / Preparation and Company
Identification of Substance or Preparation
Trade Name:
SporeClear™ Medical Device Disinfectant Spray
Use:
Disinfectant for Medical Devices
Number of composition: I 1521
Company / Undertaking Identification
Address of the Company / Undertaking:
Altos Medical LLC, Avenue Penn # 212, CA 28910 / Valencia, USA
Telephone: +1 661 775 0316 , Telefax: +1 661 775 0379
Contact Person: Mr. Gordon Wood; eMail: [email protected]
Distributed by Medline Europe Ltd:
Greenwood Drive Manor Park, Runcorn, WA7 1SE
Telephone. 01928 532 310; Telefax: 01928 532 327, Office Hours: 8:00 GMT – 17:00 GMT
Technical Inquiries: Stuart Schneider; eMail: [email protected]
Distributed by succorsale in Germany:
Hu-Friedy Mfg. Co., LLC. , Ziegeleiweg 1, 78532 Tuttlingen – Moehringen,
Telephone: + 49 74 62 9 47 90 61, Fax: + 49 74 62 9 47 90 69, Hours of operation: 8:00 CET – 17:00 CET
Technical Inquiries: Holly Church – eMail: [email protected]
Responsible:
CHEMCO123 ® - Chemical Consultancy, graduate chemist, R. Fechner,
05254 9575 05
eMail: [email protected]
Emergency - Telephone
Telephone: +1 661 775 0316
2
Hazards Identification
For Humans
Classification:
Contains poly(hexamethylenediguanid)-hydrochloride(+). May produce an allergic reaction.
Additional advice:
May cause eye irritation.
For the Environment:
Slightly water endangering.
3
Composition / Information on Ingredients
*
Chemical Characterisation:
Aqueous solution of surfactants with functional additives
Dangerous Ingredients:
CAS - No.
*
Index - No.
EC - No.
Material
quaternary ammonium compounds,
benzyl-C8-18-alkyldimethyl, chlorides
polyhexamethylenebiguanide
poly(hexamethylenediguanide)hydrochloride(+))
m% - range
Symbol
R - phrases
0,1 < C < 0,5 %
C, N
R21/22-34-50
0,1 < C < 1,0 %
Xn, N
* R22-38-4143-50
63449-41-2
612-140-00-5
264-251-5
27083-27-8
None.
None
CAS - No.
Index - No.
EC - No.
Material
m% - range
63449-41-2
612-140-00-5
264-251-5
quaternary ammonium compounds,
benzyl-C8-18-alkyldimethyl, chlorides
0,1 < C < 0,5 %
27083-27-8
None.
None
polyhexamethylenebiguanide
poly(hexamethylenediguanide)hydrochloride(+))
0,1 < C < 1,0 %
Notification according to Biozidmeldeverordnung in Germany dated from 24.05.2005:
CAS number 63449-41-2 under CAS number 68424-85-1
Polyhexamethylenebiguanide is notified under CAS 27083-27-8
None.
Pictogram H - phrases
GHS05,
GHS07,
GHS09
GHS05,
GHS07,
GHS09
(Gefahr)
H312, H302,
H314, H400
* H302, H315,
H318, H317,
H400
page 2 of 5
Tradename: SporeClear™ Medical Device Disinfectant Spray
Manufacturer: Altos Medical LLC, Avenue Penn # 212, CA 28910 / Valencia, USA, Telephone: +1 661 775 0316
Distributed by Medline Europe Ltd: Greenwood Drive Manor Park, Runcorn, WA7 1SE, Telephone. 01928 532 310,
Distributed by succorsale in Germany: Hu-Friedy Mfg. Co., LLC. , Ziegeleiweg 1, 78532 Tuttlingen – Moehringen,
Telephone: + 49 74 62 9 47 90 61, Date of issue: 15.12.2011 Replaces Data Sheet of: 06.06.2011
Remarks:
Classification and labelling of a product is indicated under item 15.
Exposure Controls / Personal Protection under item 8
R -phrase(s) under item 16
4
First Aid Measures
General advice:
Show this safety data sheet to the doctor in attendance.
Inhalation:
Not relevant
Skin Contact:
Rinse with water.
In the case of allergic reactions see a physician.
Eye Contact:
Immediately flush eye(s) with plenty of water.
If eye irritation persists, consult a specialist.
Ingestion:
Do not induce vomiting. Clean mouth with water and drink afterwards plenty of water.
If symptoms persist, call a physician.
Note to Physician:
Treat symptomatically.
Special Equipment:
n.ap.
5
Fire Fighting Measures
Suitable Extinguishing Media: The product itself does not burn. Use extinguishing measures that are appropriate
to local circumstances and the surrounding environment.
Extinguishing Media to Avoid: Carbon dioxide.
Fire and Explosion Hazards:
In the event of fire the following can be released: Carbon oxides, nitrogen oxides and hydrogen chloride gas.
Additional Information: None.
Special Protective Equipment:
Wear positive pressure self-contained breathing apparatus.
Wear full protective clothing.
6
Accidental Release Measures
Personal Precautions:
None.
Environmental Precautions:
Do not flush large quantities into surface water or sanitary sewer system. Local authorities should be advised if
significant spillages cannot be contained.
Methods for Cleaning up:
Clean-up methods - large spillage:
Soak up with inert absorbent material (universal binder). Shovel into suitable container for disposal.
After cleaning, flush away traces with water.
Clean-up methods - small spillage:
Flush away traces with water.
Further Information:
None.
page 3 of 5
7
Handling and Storage
Handling
Precautions for Safe Handling:
Handle in accordance with good industrial hygiene and safety practice.
Precautions in Case of Fire and Explosion:
The product is not flammable. Normal measures for preventive fire protection.
Storage
Storage Instructions:
No special storage conditions required. Store in a cool and shaded area. Keep container tightly closed and store
in a cool and shaded area.
Store away from:
Do not store together with strong oxidizing agents.
Further Information on Storage Conditions:
Keep at temperatures above 0 °C.
8
Exposure Controls and Personal Protection
Information on System Design:
None.
Exposure Limits:
CAS / Material
Limit Value according to TRGS 900/ EC Guidline 2000/39:
Personal Protective Equipment
General Protection and Hygiene:
Avoid contact with the eyes. When using do not eat or drink.
Respiratory Protection:
Hand Protection:
Short Term - Exposure:
Long Term - Exposure:
Eye Protection:
Skin Protection:
Further Information:
9
none
None
None.
Safety glasses
None
Choose body protection according to the amount and concentration of the dangerous
substance at the work place.
Physical and Chemical Properties
Appearance
Form: liquid
Colour: colourless
Odour: pleasant, like rose
Safety Relevant Data
pH-value:
Boiling point / Boiling - range (°C):
Melting point / Melting range (°C):
Flash point (°C):
Flammability:
Ignition temperature (°C):
Autoflammability (EC A16):
Oxidising properties:
Explosion hazard:
Explosion limits (Vol.%) lower:
Vapour pressure:
6-8
~ 100
~0
not applicable
not applicable
not applicable
not applicable
not applicable
not applicable
not applicable, upper: not applicable
not applicable
page 4 of 5
Density (g/ml):
Solubility (in Water):
Partition coefficient, n-Octanol/Water:
Viscosity:
Solvent content (m %):
VOC – content (g / kg):
Fat solubility:
Further Data
Thermal decomposition (°C):
Vapour density (Air = 1):
Evaporation rate:
10
0.950 – 1.020
soluble
no data available
like water
0,63
6,3
not applicable
no data available
not applicable
not applicable
Stability and Reactivity
Conditions to Avoid:
Stable at normal conditions.
Materials to Avoid:
None:
Hazardous Decomposition Products:
None.
11
Toxicological Information
Toxicological Tests:
Acute Health Effects of the preparation:
Inhalation, LC50 rat, (mg/l/4h):
no data available
Ingestion, LD50 rat, (mg/kg):
>> 2000
Skin - contact, LD50 rat, (mg/kg): no data available
Irritation (to skin / eye):
May cause eye irritation.
Sensitisation:
May produce an allergic reaction.
Subacute / Chronic Toxicity of the preparation:
Carcinogenicity:
not applicable
Mutagenicity:
not applicable
Teratogenicity:
not applicable
Narcotic Effects:
not applicable
12
*
*
*
*
Environmental Information
Elimination (Persistence and Degradability):
The product can be eliminated from water by abiotic processes, e.g. adsorption on activated sludge.
Behaviour in Sewage Works:
Mobility and Accumulation Potential:
Bioaccumulation is unlikely.
Ecotoxic Effects, Aquatic Toxicity:
Slightly water endangering.
Aquatic Toxicity Polyhexamethylenebiguanide (27083-27-8):
EC50/48h/daphnia = 0,04 mg / l
EC50/72Std./Selenastrum capricornutum > 0,02 mg / l
LC50/96Std./rainbow trout = 0,026 mg/l
Other Ecological Information
COD-Value, mg/g:
no data available
BOD5-Value, mg/g:
no data available
AOX-Remarks:
The product does not contains organic halogens.
Persistent, bioaccumulative and toxic substances (PBT-substance:s: None
Very persistent and very bioaccumulative substances (vPvB-substances): None.
page 5 of 5
13
Disposal Considerations
Residues
Recommendation: D1
Waste - Code - No.: 07 06 99 - wastes from the MFSU of fats, grease, soaps, detergents, disinfectants and
cosmetics, wastes n.o.s.
In addition comply with the regional authorities.
Safe Handling: See item 7 and 15.
Contaminated Packaging
Recommendation: Wash with suitable cleaner. Otherwise as described under Residues.
Safe Handling: As described under Residues.
14
Transport Information
Classification for:
Transportation by Road or Railway according to ADR/GGVS and RID/GGVE
Transportation by Vessels according to IMDG/GGVSee
Transportation by Aeroplane according to IATA-DGR/ICAO-TI
Remarks: Not dangerous goods
15
Regulatory Information
Classification:
Classification of the preparation has been done by calculation in accordance with directive 1999/45/EC,
regulation (EC) No.1272/2008, Annex VI, CLP00.
Contains poly(hexamethylenediguanide)-hydrochloride(+). May produce an allergic reaction.
Further EC – regulations:
Regulation (EC) No 648/2004 of the European Parlament and of the Council of 31 March 2004 on detergents.
not applicable
16
Other Information
R -phrase(s):
None.
* Text of R phrases mentioned in Section 3:
R21/22 - Harmful in contact with skin and if swallowed.
R34 - Causes burns.
R50 - Very toxic to aquatic organisms.
R22 - Harmful if swallowed.
R38 - Irritating to skin.
R41 - Risk of serious damage to eyes.
R43 - May cause sensitization by skin contact.
R50 - Very toxic to aquatic organisms.
* Text of H phrases mentioned in Section 3:
H312 - Harmful in contact with skin.
H302 - Harmful if swallowed.
H314 - Causes severe skin burns and eye damage.
H400 - Very toxic to aquatic life
H315 - Causes skin irritation.
H318 - Causes serious eye damage.
H317 - May cause an allergic skin reaction.
Further information to work out the Data sheet:
Data of the producer.
The statements in this Material Safety Data Sheet were made to the best of our knowledge and are as accurate as possible.
They are given for information only. They do not constitute a contractual guarantee of a product’s properties. They must neither
be altered nor transferred to other products.
war051

Safety Data Sheet in Accordance with Regulation (EC) No 1907

Transcription

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