SAFETY DATA SHEET Sample diluent
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1 1. Identification of the Substance and of the Company Product name IgE/ECP/Tryptase Sample Diluent Article number Product name Specific IgA/IgG Sample Diluent Article number Product name Use of the Preparation Autoimmunity Specific IgG Sample Diluent In vitro diagnostic test Article number Manufacturer Address Box 6460, Uppsala, SWEDEN Doc.no Ver. 8.0 Page 1(6) Telephone No Emergency Tel. No ( ) Issued by 2. Hazard Identification Health hazards Environmental hazards Fire and explosion hazards Physical/chemical hazards Quality & Environmental Management May cause an allergic skin reaction. The product contains substances with concentrations that are not classified as hazardous to the environment according to EC directive. None. None. 3. Composition/Information on Ingredients Preparation contains. EINECS No. Conc. Classification For further information, see section 16 Buffer solution Mixture of: 5-chloro-2-methyl-4- isothiazolin-3-one EC no and 2-methyl-2Hisothiazol- 3-one EC no (3:1) % < 0.003% T; R 23/24/25, C; R 34 N; R (5)
2 4. First Aid Measures IF ON SKIN: Eye contact Ingestion Gently wash with plenty of soap and water. If skin irritation or rash occurs: Get medical advice/attention. In case of contact with eyes, rinse with plenty of water and seek medical advice. Rinse mouth with water, then drink a cup of water or milk. 5. Fire Fighting Measures Specific hazards This mixture does not pose a fire hazard. Doc.no Ver. 8.0 Page 2(6) 6. Accidental Release Measures Personal precaution Clean-up method Small spillage Clean-up method Large spillage 7. Handling and Storage Handling and specific use Storage Wear suitable gloves and eye/face protection. Wipe up with adsorbent material (e.g. cloth, fleece) discharge according to local regulation. Flush into sewer with plenty of water. See Direction for Use 8. Exposure Controls/Personal Protection Occupational exposure control Respiratory protection Hand protection Material of gloves Penetration time of glove material Eye protection The expiration date for the complete package is stated on the outer label and the recommended storage temperature is 2-8 C. Each component is stable until the date stated on the respective label. Not required Not required under normal laboratory use, in other cases use disposable gloves Latex/rubber gloves Gloves resistance is not critical when the product is handled according to the directions for use. Not required under normal laboratory use Environmental exposure control The solution can be disposed with wastewater, when in compliance with local regulations. 2 (5)
3 9. Physical and Chemical Properties Property Property Form Liquid Upper/Lower Explosition limit N/A Colour Clear to Yellow Vapour pressure: - Odour None Density 1g/ml ph 7.0 Solubility in water Soluble Boiling point 100 C Viscosity - Flash point: N/A Other information - Doc.no Ver. 8.0 Page 3(6) 10. Stability and Reactivity Stability Reactivity 11. Toxicological Information Do not use after expiration date. Stable at recommended storage conditions Acute toxicity Raw material Oral: LD50 rat female mg/kg Oral: LD50 rat male mg/kg Inhalation: LD50 rat 4h 0.33mg/l Dermatal: LD50 rabbit >5.000 mg/kg Sensitization Raw material Sensitization (Guinea pig) Repeated-dose toxicity - Carcinogenicity Product do not contain any components known to have carcinogenic effect. Reproductive toxicity Product do not contain any components known to be toxic to the reproductive system and having fertility effect. Mutagenicity Product do not contain any components known to have mutagenic effect. Other information Information given is based on data from raw material 3 (5)
4 12. Ecological Information Ecotoxicity Fish Alga Aquatic invertebrates Mobility: Persistence and degradability: LC50 Rainbow trout 96h 0,19mg/l LC50 Bluegill sunfish 96h 0,28mg/l EC50 Marine alga (Skeletonema costatum) 0,003mg/l EC50 Alga (Selenastrum capreicornutum) EC50 Daphnia magna 48h 0,16mg/l Activated sludge growth inhibition EC 50: 4,5mg/l t ½ anaerobic =4.8 h t½ aerobic =17.3 h Doc.no Ver. 8.0 Page 4(6) Bioaccumulative potential: Other adverse effects: Other information 13. Disposal Considerations The product Emptied packaging Emptying instruction European waste catalogue Transport Information t½ aerobic =9.1 h Data is lacking on the product Data is lacking on the product Information given is based on data from raw material The solution can be disposed with wastewater, when in compliance with local regulations. Packaging waste made of glass, plastic and paper boxes can be sorted and recycled according to local regulations. Plastic bottles empties well, free of drip and hands over to plastic recycling. Paper boxes are hand over to relevant material recycling. The product is not classified as Dangerous Goods in the meaning of current transport regulations (ADR/RID; DGR and IMDG code). Ambient temperature not to be exceeded during transport: +27 C. 4 (5)
5 15. Regulatory Information >0,0015% Mixture of: 5-chloro-2-methyl-4-isothiazolin-3-one EC no and 2-methyl- 2Hisothiazol-3-one EC no (3:1)Mixture of: 5-chloro-2-methyl-4-isothiazolin-3-one EC no and 2-methyl-2Hisothiazol-3-one EC no (3:1) Classification according to European directive on classification of dangerous preparations 1999/45/EEC: Xi: Irritant, R43 May cause sensitisation by skin contact Classification according to regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures: Warning May cause an allergic skin reaction Doc.no Ver. 8.0 Page 5(6) 16. Other Information Internal No.: Revised: Section 2: New health warning according to regulation (EC) No 1272/2008, glass included in waste packaging materials, general update according to regulation (EC) No 1272/2008. Replaces date: 21 April 2010 List of relevant R phrases in section 3: T toxic ; R 23/24/25 Toxic by inhalation, in contact with skin and if swallowed, C corrosive; R 34 Causes burns; N Dangerous for the environment; R Very toxic to aquatic organisms, may cause long term adverse effect in the aquatic environment. DISCLAIMER: The information contained in the SDS (Safety Data Sheet) is believed to be correct as of its date of issuance. By making the SDS available, Phadia does not make any express or implied warranty (including any warranty of merchantability or fitness for a particular purpose) regarding the SDS, its accuracy or the product to which it relates. Anyone using this information agrees that Phadia shall not be held liable (based on its negligence or otherwise) for any personal injury or other damage relating to, or arising from such use, including direct, incidental, or consequential damage and such user agrees to indemnify Phadia for any claims arising out of its use. 5 (5)
6 Document name SAMPLE DILUENT SDS Number Version 8.0 Issued by Anna-Tora Martin 2010-Jul-26 16:16 CET Valid by 2010-Jul-26 16:16 CET Doc.no Ver. 8.0 Page 6(6)
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