(International) Recommended use of the chemical and restrictions on use Restrictions on use : For professional users only.
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1 SECTION 1. IDENTIFICATION Product name : Mat.-No./ Genisys-No. : Manufacturer or supplier's details Company name of supplier : Roche Diagnostics - Address : 9115 Hague Road Indianapolis IN Telephone : Emergency telephone: In case of emergencies: : CHEMTREC (U.S. or Canada) (International) Recommended use of the chemical and restrictions on use Restrictions on use : For professional users only. SECTION 2. HAZARDS IDENTIFICATION GHS Classification Not a hazardous substance or mixture. GHS Label element Not a hazardous substance or mixture. Other hazards None known. SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS Substance / Mixture Substance name : Mixture : Bluing Reagent Hazardous ingredients Chemical Name CAS-No. Concentration (% w/w) Sodium carbonate >= 5 - < 10 Lithium carbonate >= 1 - < 5 SECTION 4. FIRST AID MEASURES General advice If inhaled : Do not leave the victim unattended. : Move to fresh air. If unconscious place in recovery position and seek medical advice. 1 / 12
2 If symptoms persist, call a physician. In case of skin contact In case of eye contact If swallowed Most important symptoms and effects, both acute and delayed Notes to physician : If on skin, rinse well with water. : Immediately flush eye(s) with plenty of water. Remove contact lenses. Protect unharmed eye. If eye irritation persists, consult a specialist. : Keep respiratory tract clear. Do not give milk or alcoholic beverages. Never give anything by mouth to an unconscious person. If symptoms persist, call a physician. Rinse mouth with water. : None known. : The first aid procedure should be established in consultation with the doctor responsible for industrial medicine. SECTION 5. FIRE-FIGHTING MEASURES Suitable extinguishing media Specific hazards during fire fighting Hazardous combustion products Further information Special protective equipment for fire-fighters : Use extinguishing measures that are appropriate to local circumstances and the surrounding environment. : No information available. : No hazardous combustion products are known : Standard procedure for chemical fires. Use extinguishing measures that are appropriate to local circumstances and the surrounding environment. : Wear self-contained breathing apparatus for firefighting if necessary. SECTION 6. ACCIDENTAL RELEASE MEASURES Personal precautions, protective equipment and emergency procedures Environmental precautions Methods and materials for containment and cleaning up : Refer to protective measures listed in sections 7 and 8. : Local authorities should be advised if significant spillages cannot be contained. : Wipe up with absorbent material (e.g. cloth, fleece). Keep in suitable, closed containers for disposal. SECTION 7. HANDLING AND STORAGE 2 / 12
3 Advice on protection against fire and explosion : Normal measures for preventive fire protection. Advice on safe handling : For personal protection see section 8. Smoking, eating and drinking should be prohibited in the application area. Conditions for safe storage Technical measures/precautions Materials to avoid : Electrical installations / working materials must comply with the technological safety standards. : See label, package insert or internal guidelines : No materials to be especially mentioned. SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION Ingredients with workplace control parameters Contains no substances with occupational exposure limit values. Hazardous components without workplace control parameters Ingredients CAS-No. Sodium carbonate Lithium carbonate Engineering measures Personal protective equipment Respiratory protection Hand protection : No personal respiratory protective equipment normally required. Material Remarks Eye protection Skin and body protection Hygiene measures : Protective gloves : Wear appropriate protective gloves to prevent skin contact. Replace torn or punctured gloves promptly. : Safety glasses : Protective suit : Handle in accordance with good industrial hygiene and safety practice. SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES Appearance Color Odor Odor Threshold : liquid 3 / 12
4 ph Melting point/range Boiling point/boiling range Flash point Evaporation rate Flammability (solid, gas) Upper explosion limit Lower explosion limit Vapor pressure Relative vapor density Relative density Solubility(ies) Water solubility Solubility in other solvents Partition coefficient: n- octanol/water Autoignition temperature Decomposition temperature Viscosity Viscosity, dynamic Viscosity, kinematic : alkaline : does not flash : The product is not flammable. SECTION 10. STABILITY AND REACTIVITY Reactivity Chemical stability Possibility of hazardous reactions Conditions to avoid Incompatible materials Hazardous decomposition products : No dangerous reaction known under conditions of normal use. : Stable under normal conditions. : Stable under recommended storage conditions. No hazards to be specially mentioned. 4 / 12
5 SECTION 11. TOXICOLOGICAL INFORMATION Acute toxicity Product: Acute oral toxicity Acute inhalation toxicity : Acute toxicity estimate: > 5,000 mg/kg Method: Calculation method : Acute toxicity estimate: > 40 mg/l Exposure time: 4 h Test atmosphere: vapor Method: Calculation method Acute oral toxicity : LD50 Oral (Rat): 4,090 mg/kg LD50 Oral (Mouse): 6,600 mg/kg Acute inhalation toxicity : LC50 (Mouse): mg/l1200 mg/m3 Exposure time: 2 h Test atmosphere: dust/mist LC50 (Rat): 2.3 mg/l2300 mg/m3 Exposure time: 2 h Test atmosphere: dust/mist Acute oral toxicity : LD50 Oral (Rat): 525 mg/kg LD50 Oral (Mouse): 531 mg/kg LD50 Oral (Dog): 500 mg/kg LD50 Oral (Rabbit): 404 mg/kg Acute inhalation toxicity : LC50 (Rat): > 2.17 mg/l Exposure time: 4 h Skin corrosion/irritation Remarks: May cause skin irritation in susceptible persons. Remarks: May cause skin irritation in susceptible persons. Serious eye damage/eye irritation 5 / 12
6 Result: Irritating to eyes. Remarks: May cause irreversible eye damage. Result: Irritating to eyes. Respiratory or skin sensitization Skin sensitization: Respiratory sensitization: Germ cell mutagenicity Genotoxicity in vitro : Test Type: Ames test Result: negative Carcinogenicity IARC No ingredient of this product present at levels greater than or equal to 0.1% is identified as probable, possible or confirmed human carcinogen by IARC. OSHA NTP No ingredient of this product present at levels greater than or equal to 0.1% is identified as a carcinogen or potential carcinogen by OSHA. No ingredient of this product present at levels greater than or equal to 0.1% is identified as a known or anticipated carcinogen by NTP. Reproductive toxicity STOT-single exposure Assessment: The substance or mixture is not classified as specific target organ toxicant, single exposure. Assessment: The substance or mixture is not classified as specific target organ toxicant, single exposure. STOT-repeated exposure Assessment: The substance or mixture is not classified as specific target organ toxicant, repeated exposure. 6 / 12
7 Assessment: The substance or mixture is not classified as specific target organ toxicant, repeated exposure. Aspiration toxicity No aspiration toxicity classification No data available SECTION 12. ECOLOGICAL INFORMATION Ecotoxicity Product: Ecotoxicology Assessment Toxicity Data on Soil Other organisms relevant to the environment : Not expected to adsorb on soil. Toxicity to fish Toxicity to daphnia and other aquatic invertebrates Ecotoxicology Assessment Acute aquatic toxicity Chronic aquatic toxicity Toxicity Data on Soil Other organisms relevant to the environment Toxicity to fish Toxicity to daphnia and other aquatic invertebrates Ecotoxicology Assessment Toxicity Data on Soil : LC50 (Lepomis macrochirus (Bluegill sunfish)): 300 mg/l Exposure time: 96 h : EC50 (Daphnia magna (Water flea)): 265 mg/l Exposure time: 48 h : This product has no known ecotoxicological effects. : This product has no known ecotoxicological effects. : Not expected to adsorb on soil. : LC50 (Oncorhynchus mykiss (rainbow trout)): 30.3 mg/l Exposure time: 96 h : EC50 (Daphnia magna (Water flea)): 33 mg/l Exposure time: 48 h : Not expected to adsorb on soil. 7 / 12
8 Other organisms relevant to the environment Persistence and degradability Impact on Sewage Treatment : Do not discharge product into the aquatic environment without pretreatment (biological treatment plant). Bioaccumulative potential Partition coefficient: n- octanol/water Partition coefficient: n- octanol/water : Remarks : Remarks Mobility in soil No data available Other adverse effects Product: Ozone-Depletion Potential : Regulation: 40 CFR Protection of Environment; Part 82 Protection of Stratospheric Ozone - CAA Section 602 Class I Substances Remarks: This product neither contains, nor was manufactured with a Class I or Class II ODS as defined by the U.S. Clean Air Act Section 602 (40 CFR 82, Subpt. A, App.A + B). Adsorbed organic bound halogens (AOX) Additional ecological information Adsorbed organic bound halogens (AOX) : Remarks: Not applicable : Remarks: Not applicable SECTION 13. DISPOSAL CONSIDERATIONS Disposal methods Waste from residues : The product has to be disposed of as laboratory chemical in accordance with local regulations. 8 / 12
9 Contaminated packaging : Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. SECTION 14. TRANSPORT INFORMATION International Regulation UNRTDG Not regulated as a dangerous good IATA-DGR Not regulated as a dangerous good IMDG-Code Not regulated as a dangerous good Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code Not applicable for product as supplied. Domestic regulation 49 CFR Not regulated as a dangerous good SECTION 15. REGULATORY INFORMATION EPCRA - Emergency Planning and Community Right-to-Know CERCLA Reportable Quantity This material does not contain any components with a CERCLA RQ. SARA 304 Extremely Hazardous Substances Reportable Quantity This material does not contain any components with a section 304 EHS RQ. SARA 311/312 Hazards SARA 302 SARA 313 : Acute Health Hazard : No chemicals in this material are subject to the reporting requirements of SARA Title III, Section 302. : The following components are subject to reporting levels established by SARA Title III, Section 313: Lithium carbonate % Clean Air Act This product neither contains, nor was manufactured with a Class I or Class II ODS as defined by the U.S. Clean Air Act Section 602 (40 CFR 82, Subpt. A, App.A + B). This product does not contain any hazardous air pollutants (HAP), as defined by the U.S. Clean Air Act Section 12 (40 CFR 61). This product does not contain any chemicals listed under the U.S. Clean Air Act Section 112(r) for Accidental Release Prevention (40 CFR , Subpart F). This product does not contain any chemicals listed under the U.S. Clean Air Act Section 111 SOCMI Intermediate or Final VOC's (40 CFR ). Clean Water Act 9 / 12
10 This product does not contain any Hazardous Substances listed under the U.S. CleanWater Act, Section 311, Table 116.4A. This product does not contain any Hazardous Chemicals listed under the U.S. CleanWater Act, Section 311, Table This product does not contain any toxic pollutants listed under the U.S. Clean Water Act Section 307 US State Regulations Massachusetts Right To Know Pennsylvania Right To Know New Jersey Right To Know Lithium carbonate % Water % Sodium carbonate % Water % Sodium carbonate % Lithium carbonate % California Prop. 65 WARNING: This product contains a chemical known in the State of California to cause birth defects or other reproductive harm. Lithium carbonate The ingredients of this product are reported in the following inventories: CH INV TSCA DSL AICS NZIoC ENCS ISHL KECI PICCS IECSC : On TSCA Inventory : All components of this product are on the Canadian DSL : Not in compliance with the inventory Water TSCA list No substances are subject to a Significant New Use Rule. No substances are subject to TSCA 12(b) export notification requirements. 10 / 12
11 Health Instability SAFETY DATA SHEET SECTION 16. OTHER INFORMATION Full text of other abbreviations (Q)SAR - (Quantitative) Structure Activity Relationship; ASTM - American Society for the Testing of Materials; bw - Body weight; DIN - Standard of the German Institute for Standardisation; ECx - Concentration associated with x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule; ErCx - Concentration associated with x% growth rate response; GHS - Globally Harmonized System; IARC - International Agency for Research on Cancer; IATA - International Air Transport Association; IBC - International Code for the Construction and Equipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IMDG - International Maritime Dangerous Goods; IMO - International Maritime Organization; ISO - International Organisation for Standardization; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships; n.o.s. - Not Otherwise Specified; NO(A)EC - No Observed (Adverse) Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable Effect Loading Rate; OECD - Organization for Economic Co-operation and Development; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet; UN - United Nations; vpvb - Very Persistent and Very Bioaccumulative; DSL - Domestic Substances List (Canada); KECI - Korea Existing Chemicals Inventory; TSCA - Toxic Substances Control Act (United States); AICS - Australian Inventory of Chemical Substances; IECSC - Inventory of Existing Chemical Substances in China; ENCS - Existing and New Chemical Substances (Japan); ISHL - Industrial Safety and Health Law (Japan); PICCS - Philippines Inventory of Chemicals and Chemical Substances; NZIoC - New Zealand Inventory of Chemicals; TCSI - Taiwan Chemical Substance Inventory; CERCLA - Comprehensive Environmental Response, Compensation, and Liability Act; DOT - Department of Transportation; EHS - Extremely Hazardous Substance; HMIS - Hazardous Materials Identification System; MSHA - Mine Safety and Health Administration; NFPA - National Fire Protection Association; RCRA - Resource Conservation and Recovery Act; RQ - Reportable Quantity; SARA - Superfund Amendments and Reauthorization Act; CMR - Carcinogen, Mutagen or Reproductive Toxicant; GLP - Good Laboratory Practice; ERG - Emergency Response Guide; NTP - National Toxicology Program; UNRTDG - United Nations Recommendations on the Transport of Dangerous Goods Further information NFPA: Flammability HMIS III: 0 HEALTH FLAMMABILITY 0 PHYSICAL HAZARD 0 Special hazard. 0 = not significant, 1 =Slight, 2 = Moderate, 3 = High 4 = Extreme, * = Chronic Revision Date : 11 / 12
12 The information provided in this Material Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information given is designed only as a guidance for safe handling, use, processing, storage, transportation, disposal and release and is not to be considered a warranty or quality specification. The information relates only to the specific material designated and may not be valid for such material used in combination with any other materials or in any process, unless specified in the text. US / Z8 12 / 12
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