Page1of6 @ Beckma n Coulter® MATERIAL SAFETY DATA SHEET Section 1 Company and Product Identification Product Name Bilirubin Calibrator Part Number 465915 Doc. ID 465915­75 AD Issued (year/month/day) Revised (year/month/day) 2006/03/29 Product Use For In Vitro Diagnostic Use. See product literature for details. Series Name SYNCHRON Systems Manufacturer Beckman Coulter, Inc. 4300 Harbor Blvd. Fullerton, CA 92835­3100, U.S.A. Distributor and Emergency Phone No. Refer to attached list, Document ID:472050, for local distributor and emergency phone numbers. Section 2 Composition and Information on Ingredients HazardousIngredients: Meets Hazardous Criteria: Chemical Name CAS# %bywt. EU USOSHA WHMIS Ethylene Glycol 107­21­1 25 Xn;R 22 Yes Exempt See Section 15 Regulatory Information for additional information on hazard classifications. Section 3 Hazards Identification Emergency Overview Amber; Translucent; Liquid; Odorless Nonflammable aqueous solution. Skin, eye and respiratory tract irritant. Harmful if swallowed. Contains material of human origin. Physical Hazards No physical hazards were determined from a review of available literature. Potential Health Effects Summary May cause irritation of respiratory tract, skin and eyes; central nervous system depression; severe kidney damage and reproductive effects. This product contains material of human origin and should be considered as potentially capable of transmitting infectious diseases. See Section 11 Toxicological Information for more detailed health information. Product Hazard Classifications EU: Xn;R22 WHMIS: Exempt US OSHA: Hazardous Beckman CoulterSafety Rating Flammability (Section V):0 Health (Section XI):2 Reactivity with Water (Section X):0 Contact (Section VIII): 2 Code 0=none 1=slight 2=caution 3=severe 2006 Beckman Coulter, Inc. Global MSDS – English = Page 1 = Bilirubin Calibrator MSDS # 465915­75 AD Page2of6 Section 4 First Aid Measures Inhalation If product is inhaled, move exposed individual to fresh air. If individual is not breathing, begin artificial respiration immediately and obtain medical attention. Eye Contact If product is splashed in eyes, wash eyes under gently running water for 15 minutes or longer, making sure that the eyelids are held open. Obtain medical attention. Skin Contact In case of skin contact, flush with copious amounts of water for at least 15 minutes. Remove contaminated clothing and shoes. If pain or irritation occur, obtain medical attention. Ingestion If ingested, wash mouth out with water. If irritation or discomfort occurs, seek medical attention. Section 5 Fire Fighting Measures Flash Point Not applicable FlammableLimits Not applicable AutoignitionTemp. Not applicable Extinguishing Media Use extinguishing media suitable for surrounding fire. Special Fire and Explosion Hazards No special hazards determined. Hazardous Combustion Products No combustion products posing significant hazards are expected from this product (an aqueous solution). Protective Equipment for Firefighters Self­contained breathing apparatus is recommended for firefighters. Section 6 Accidental Release Measures Personal Precautions This product contains a material of biological origin. Use universal precautions during clean up procedures. Spill and Leak Procedures As a precautionary measure, treat spilled material with a 1:10 bleach/water solution. Absorb liquid and place in container suitable for disposal. Avoid generation of aerosols during clean up. Comply with applicable waste disposal regulations. Environmental Precautions Contain spill to prevent migration. Section 7 Handling and Storage Handling Precautions This product should be handled as though capable of transmitting infectious diseases. Universal precautions should be followed when using this product. Recommended Storage Conditions Keep away from incompatible material (see Section 10). To maintain efficacy, store according to the instructions in the product labeling. Section 8 Exposure Controls and Personal Protection Exposure Limits US OSHA: None established = Page 2 = Bilirubin Calibrator MSDS # 465915­75 AD Page3of6 Section 8 Exposure Controls and Personal Protection (Continued) ACGIH: Ethylene Glycol 100 mg/m3 Ceiling (aerosol only) DFG MAK: Ethylene Glycol 10 ppm MAK; 26 mg/m3 MAK; 20 ppm Peak; 52 mg/m3 Peak; skin notation Engineering Controls Use in well ventilated area. Respiratory Protection Under normal conditions, the use of this product should not require respiratory protection. If overexposure should occur and ventilation is not adequate to maintain airborne concentrations at acceptable levels, the use of respiratory protection should be evaluated by a qualified professional. Eye Protection Safety glasses or chemical goggles should be worn to prevent eye contact. Skin Protection Impervious gloves, such as Nitrile or equivalent, should be worn to prevent skin contact. Section 9 Physical and Chemical Properties Physical State Liquid Color Amber Transparency Translucent Odor Odorless Odor Threshold Not applicable pH 8.6 +/­ 0.2 Boiling Point Not available Melting Point Not available Specific Gravity 1.059 @20°C Vapor Pressure Not available Vapor Density Not available Evaporation Rate Not available Solubility Water Miscible Organic Not available Section 10 Stability and Reactivity Stability Stable under normal temperatures and pressures. Hazardous Incompatibilities Strong oxidizers Strong acids Strong bases Hazardous Decomposition Products When stored as labeled, no known hazardous decomposition products are formed during the shelf­life of this product. Conditions to Avoid Keep away from incompatible material. = Page 3 = Bilirubin Calibrator MSDS # 465915­75 AD Page4of6 Section 11 Toxicological Information Toxicity Data for Hazardous Ingredients Ethylene Glycol Oral LD50 Rat: 4000 mg/kg; Dermal LD50 Rabbit: 9530 µL/kg Primary Routes of Exposure Common routes of entry include inhalation, ingestion and eye/skin contact. Specific paths of concern for potentially infectious materials are skin puncture, contact with broken skin, contact with mucous membranes and inhalation of aerosolized material. Potential Effects of Acute Exposure This product contains material of human origin and should be considered as potentially capable of transmitting infectious diseases. Exposure to ethylene glycol may result in eye and respiratory tract irritation. Inhalation of mists and absorption through skin may cause central nervous system depression. Ingestion may cause severe central nervous system depression, kidney failure, heart failure or respiratory arrest. Potential Effects of Chronic Exposure Prolonged or repeated exposure to ethylene glycol may result in mild irritation and central nervous system depression; symptoms may include throat irritation, drowsiness, headache and backache. Contact with skin and eyes may result in dermatitis and conjunctivitis with red, scaly skin and inflamed eyes. Animal studies indicate repeated ingestion of small amounts can cause severe kidney damage. Symptoms of Overexposure Symptoms of overexposure may include: eye, skin, nose and throat irritation; headache, weakness, dizziness, confusion, nausea and vomiting. Severe cases may exhibit difficulty in breathing, irregular heartbeat, reddish colored skin, unconsciousness, convulsions, coma and death. Symptoms may be delayed for several hours after exposure. Carcinogenicity No ingredients in this product are listed as carcinogens by ACGIH, IARC, NTP, OSHA or 67/548/EEC Annex I. Other Effects Reproductive effects have been reported in animal studies. Conditions Aggravated by Exposure Individuals with eye and skin disorders may find these conditions aggravated by exposure to this product. Individuals with central nervous system, cardiovascular, or kidney disorders may find these conditions aggravated by exposure to this product. Section 12 Ecological Information Ecotoxicity No information available. Biodegradability No information available. Mobility No information available. Section 13 Disposal Considerations Waste Disposal Dispose of waste product, unused product and contaminated packaging in compliance with federal, state and local regulations. If unsure of the applicable requirements, contact the authorities for information. Section 14 Transport Information Transportation of this product is not regulated under ICAO, IMDG, US DOT, European ADR or Canadian TDG. = Page 4 = Bilirubin Calibrator MSDS # 465915­75 AD Page5of6 Section 15 Regulatory Information US FederalandStateRegulations SARA 313 Acetaldehyde is subject to reporting requirements of Section 313, Title III of SARA. Ethylene Oxide is subject to reporting requirements of Section 313, Title III of SARA. Ethylene Glycol is subject to reporting requirements of Section 313, Title III of SARA. 1,4­Dioxane is subject to reporting requirements of Section 313, Title III of SARA. Hydrochloric Acid is subject to reporting requirements of Section 313, Title III of SARA. CERCLA RG’s, 40 CFR 302.4 Acetaldehyde is listed. Ethylene Oxide is listed. Ethylene Glycol is listed. 1,4­Dioxane is listed. Sodium Hydroxide is listed. Hydrochloric Acid is listed. California Proposition 65 Acetaldehyde has been identified by the State of California to cause cancer. The State of California has adopted a regulation which requires a warning be given to individuals who may be exposed to chemicals identified by the State to cause cancer or reproductive harm. Accordingly, Beckman Coulter advises you of the following warning: WARNING:This product contains a chemical known to the State of California to cause cancer. Ethylene Oxide has been identified by the State of California to cause cancer and reproductive harm. The State of California has adopted a regulation which requires a warning be given to individuals who may be exposed to chemicals identified by the State to cause cancer or reproductive harm. Accordingly, Beckman Coulter advises you of the following warning: WARNING:This product contains a chemical known to the State of California to cause cancer and reproductive harm. 1,4­Dioxane has been identified by the State of California to cause cancer. The State of California has adopted a regulation which requires a warning be given to individuals who may be exposed to chemicals identified by the State to cause cancer or reproductive harm. Accordingly, Beckman Coulter advises you of the following warning: WARNING:This product contains a chemical known to the State of California to cause cancer. Massachusetts MSL Acetaldehyde is listed. Ethylene Oxide is listed. Ethylene Glycol is listed. 1,4­Dioxane is listed. Sodium Hydroxide is listed. Hydrochloric Acid is listed. Magnesium Chloride, Hexahydrate is listed. New Jersey Dept. of Health RTK List Acetaldehyde is listed. Ethylene Oxide is listed. Ethylene Glycol is listed. 1,4­Dioxane is listed. Sodium Hydroxide is listed. Hydrochloric Acid is listed. Magnesium Chloride, Hexahydrate is listed. Pennsylvania RTK Acetaldehyde is listed. Ethylene Oxide is listed. Ethylene Glycol is listed. 1,4­Dioxane is listed. Sodium Hydroxide is listed. Hydrochloric Acid is listed. Magnesium Chloride, Hexahydrate is listed. = Page 5 = Bilirubin Calibrator MSDS # 465915­75 AD Page6of6 Section 15 Regulatory Information (Continued) EU Labeling Classification Classification Risk and Safety Phrases Xn Harmful R22 Harmful if swallowed. Canada This product is exempt from WHMIS label and MSDS requirements. PIN: Not applicable Ingredients on Ingredient Disclosure List: Acetaldehyde Ethylene Oxide Ethylene Glycol 1,4­Dioxane Sodium Hydroxide Hydrochloric Acid Ingredients with unknown toxicological properties: Product is exempt Section 16 Other Information For further information, please contact your local Beckman Coulter representative. WHILE BECKMAN COULTER, INC. BELIEVES THE INFORMATION CONTAINED HEREIN IS VALID AND ACCURATE, BECKMAN COULTER MAKES NO WARRANTY OR REPRESENTATION AS TO ITS VALIDITY, ACCURACY, OR CURRENCY. BECKMAN COULTER SHALL NOT BE LIABLE OR OTHERWISE RESPONSIBLE IN ANY WAY FOR USE OF EITHER THIS INFORMATION OR MATERIALS TO WHICH IT APPLIES. DISPOSAL OF HAZARDOUS MATERIALS MAY BE SUBJECT TO LOCAL LAWS OR REGULATIONS. Printed in U.S.A. = Page 6 =