Page1of13 @ Beckma n Coulter® Kit MSDS Doc. ID:33565­75: Rev. AC Product Information Product Name TESTOSTERONE CALIBRATORS Part Number 33565 Doc. ID 33565­75 AC Issued (year/month/day) Revised (year/month/day) 2007/06/15 Series Name: ACCESS Additional Product Information: For In Vitro Diagnostic Use. See product literature for details. Components Description TESTOSTERONE CALIBRATOR S0 TESTOSTERONE CALIBRATORS S1, S2, S3, S4, and S5 Transport Information Transportation of this product is not regulated under ICAO, IMDG, US DOT, European ADR or Canadian TDG. 2007 Beckman Coulter, Inc. Global MSDS – English = Page 1 = Page2of13 @ Beckma n Coulter® MATERIAL SAFETY DATA SHEET Section 1 Company and Product Identification Product Name TESTOSTERONE CALIBRATOR S0 Part Number Component of P/N 33565 TESTOSTERONE CALIBRATORS Doc. ID 33565­75 AC Issued (year/month/day) Revised (year/month/day) 2007/06/15 Series Name ACCESS Manufacturer Beckman Coulter, Inc. 4300 Harbor Blvd. Fullerton, CA 92835­3100, U.S.A. ECREP Address: Beckman Coulter Ireland, Inc. Mervue Business Park, Mervue, Galway, Ireland 353 91 774068 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 ProClin* 300 – 0.5% T;R23/24/25­43 C;R34 N ;R50­53 No Exempt See Section 15 Regulatory Information for additional information on hazard classifications. Section 3 Hazards Identification Emergency Overview Colorless; Clear; Liquid; Odorless Nonflammable aqueous solution. Skin, eye and respiratory tract irritant. Potential sensitizer. Contains material of animal origin. Physical Hazards Sodium azide forms explosive compounds with heavy metals. This product contains concentrations of azide<0.1% (w/w) which with repeated contact with lead and copper commonly found in plumbing drains may result in the build up of shock sensitive compounds. Potential Health Effects Summary Exposure may result in irritation of skin, eyes, and mucous membranes. This product contains material of animal origin and should be considered as potentially capable of transmitting infectious diseases. See Section 11 Toxicological Information for more detailed health information. = Page 2 = TESTOSTERONE CALIBRATORS Doc. ID: 33565­75 AC Page3of13 TESTOSTERONE CALIBRATOR S0 Section 3 Hazards Identification (Continued) Product Hazard Classifications EU: Xi;R43 WHMIS: Exempt US OSHA: Not applicable Beckman CoulterSafety Rating Flammability (Section V):0 Health (Section XI):1 Reactivity with Water (Section X):0 Contact (Section VIII):1 Code 0=none 1=slight 2=caution 3=severe 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 enters eyes, wash eyes gently under running water for 15 minutes or longer, making sure that the eyelids are held open. If pain or irritation occur, 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 None identified. Hazardous Combustion Products No combustion products posing significant hazards are expected from this product (a dilute 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. = Page 3 = TESTOSTERONE CALIBRATORS Doc. ID: 33565­75 AC Page4of13 TESTOSTERONE CALIBRATOR S0 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 ACGIH: None established DFG MAK: None established Engineering Controls No special engineering controls are required. Use with good general ventilation. 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 Colorless Transparency Clear Odor Odorless Odor Threshold Not applicable pH 7.7 Boiling Point Not available Melting Point Not available SpecificGravity 1.0345 @20°C Vapor Pressure Not available Vapor Density Not available Evaporation Rate Not available Solubility Water Miscible Organic Not available = Page 4 = TESTOSTERONE CALIBRATORS Doc. ID: 33565­75 AC Page5of13 TESTOSTERONE CALIBRATOR S0 Section 10 Stability and Reactivity Stability Stable under normal temperatures and pressures. Hazardous Incompatibilities Metals and metallic compounds Strong oxidizers Strong acids Strong bases Sodium azide forms explosive compounds with heavy metals. This product contains concentrations of azide<0.1% (w/w) which with repeated contact with lead and copper commonly found in plumbing drains may result in the build up of shock sensitive compounds. Hazardous Decomposition Products No decomposition products posing significant hazards would be expected from this product (a dilute aqueous solution). Conditions to Avoid Keep away from incompatible material. Section 11 Toxicological Information Toxicity Data for Hazardous Ingredients Not applicable 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 Exposure to ProClin 300 may result in irritation of skin, eyes and mucous membranes. Skin contact may result in possible sensitization. Eye contact may cause clouding of the cornea. Ingestion may cause gastrointestinal irritation; large doses given to animals resulted in collapse and coma. This product contains material of animal origin and should be considered as potentially capable of transmitting infectious diseases. Potential Effects of Chronic Exposure Frequent or long­term eye and skin exposure to ProClin 300 may result in conjunctivitis and dermatitis. Symptoms of Overexposure Symptoms may include: coughing, headache, fatigue, nausea, vomiting, dizziness, blurred vision, red and watery eyes, abdominal pain and unconsciousness. Carcinogenicity This product does not contain a reportable concentration (0.1%) of any ingredient listed as carcinogen by ACGIH, IARC, NTP, OSHA or 67/548/EEC Annex I. Other Effects None identified. Conditions Aggravated by Exposure None identified. Section 12 Ecological Information Ecotoxicity No information available. Biodegradability No information available. Mobility No information available. = Page 5 = TESTOSTERONE CALIBRATORS Doc. ID: 33565­75 AC Page6of13 TESTOSTERONE CALIBRATOR S0 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. Sodium azide preservative may form explosive compounds in metal drain lines. See NIOSH Bulletin: Explosive Azide Hazard (8/16/76). Section 14 Transport Information Transportation of this product is not regulated under ICAO, IMDG, US DOT, European ADR or Canadian TDG. Section 15 Regulatory Information US FederalandStateRegulations SARA 313 Ethylene Oxide 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. Sodium Azide is subject to reporting requirements of Section 313, Title III of SARA. CERCLA RG’s, 40 CFR 302.4 Ethylene Oxide is listed. 1,4­Dioxane is listed. Sodium Azide is listed. California Proposition 65 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 hasadopted aregulation which requires awarning 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 Ethylene Oxide is listed. 1,4­Dioxane is listed. Sodium Azide is listed. New Jersey Dept. of Health RTK List Ethylene Oxide is listed. 1,4­Dioxane is listed. Sodium Azide is listed. Pennsylvania RTK Ethylene Oxide is listed. 1,4­Dioxane is listed. Sodium Azide is listed. Dipropylene Glycol is listed. EU Labeling Classification Classification Risk and Safety Phrases Xi Irritant R43 May cause sensitization by skin contact. S28 After contact with skin, wash immediately with plenty of water. S37 Wear suitable gloves. = Page 6 = TESTOSTERONE CALIBRATORS Doc. ID: 33565­75 AC Page7of13 TESTOSTERONE CALIBRATOR S0 Section 15 Regulatory Information (Continued) Canada This product is exempt from WHMIS label and MSDS requirements. PIN: Not applicable Ingredients on Ingredient Disclosure List: Ethylene Oxide 1,4­Dioxane Sodium Azide Ingredients with unknown toxicological properties: Product is exempt Section 16 Other Information * ProClin is a trademark of the Rohm and Haas Company. 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 REPRESENTATIONASTOITSVALIDITY,ACCURACY,ORCURRENCY.BECKMANCOULTERSHALLNOTBELIABLEOROTHERWISERESPONSIBLEINANYWAYFORUSE OFEITHERTHISINFORMATIONORMATERIALSTOWHICHITAPPLIES.DISPOSALOFHAZARDOUSMATERIALSMAYBESUBJECTTOLOCALLAWSORREGULATIONS. Printed in U.S.A. = Page 7 = Page8of13 @ Beckma n Coulter® MATERIAL SAFETY DATA SHEET Section 1 Company and Product Identification Product Name TESTOSTERONE CALIBRATORS S1, S2, S3, S4, and S5 Part Number Component of P/N 33565 TESTOSTERONE CALIBRATORS Doc. ID 33565­75 AC Issued (year/month/day) Revised (year/month/day) 2007/06/15 Series Name ACCESS Manufacturer Beckman Coulter, Inc. 4300 Harbor Blvd. Fullerton, CA 92835­3100, U.S.A. ECREP Address: Beckman Coulter Ireland, Inc. Mervue Business Park, Mervue, Galway, Ireland 353 91 774068 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 ProClin* 300 – 0.5% T;R23/24/25­43 C;R34 N ;R50­53 No Exempt See Section 15 Regulatory Information for additional information on hazard classifications. Section 3 Hazards Identification Emergency Overview Colorless; Clear; Liquid; Odorless Nonflammable aqueous solution. Skin, eye and respiratory tract irritant. Potential sensitizer. Contains material of animal origin. Physical Hazards Sodium azide forms explosive compounds with heavy metals. This product contains concentrations of azide<0.1% (w/w) which with repeated contact with lead and copper commonly found in plumbing drains may result in the build up of shock sensitive compounds. Potential Health Effects Summary Exposure may result in irritation of skin, eyes, and mucous membranes. This product contains material of animal origin and should be considered as potentially capable of transmitting infectious diseases. See Section 11 Toxicological Information for more detailed health information. = Page 8 = TESTOSTERONE CALIBRATORS Doc. ID: 33565­75 AC Page9of13 TESTOSTERONE CALIBRATORS S1, S2, S3, S4, and S5 Section 3 Hazards Identification (Continued) Product Hazard Classifications EU: Xi;R43 WHMIS: Exempt US OSHA: Not applicable Beckman CoulterSafety Rating Flammability (Section V):0 Health (Section XI):1 Reactivity with Water (Section X):0 Contact (Section VIII):1 Code 0=none 1=slight 2=caution 3=severe 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 enters eyes, wash eyes gently under running water for 15 minutes or longer, making sure that the eyelids are held open. If pain or irritation occur, 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 None identified. Hazardous Combustion Products No combustion products posing significant hazards are expected from this product (a dilute 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. = Page 9 = TESTOSTERONE CALIBRATORS Doc. ID: 33565­75 AC Page 10 of 13 TESTOSTERONE CALIBRATORS S1, S2, S3, S4, and S5 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 ACGIH: None established DFG MAK: None established Engineering Controls No special engineering controls are required. Use with good general ventilation. 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 Colorless Transparency Clear Odor Odorless Odor Threshold Not applicable pH 7.7 Boiling Point Not available Melting Point Not available SpecificGravity 1.0345 @20°C Vapor Pressure Not available Vapor Density Not available Evaporation Rate Not available Solubility Water Miscible Organic Not available = Page 10 = TESTOSTERONE CALIBRATORS Doc. ID: 33565­75 AC Page 11 of 13 TESTOSTERONE CALIBRATORS S1, S2, S3, S4, and S5 Section 10 Stability and Reactivity Stability Stable under normal temperatures and pressures. Hazardous Incompatibilities Metals and metallic compounds Strong oxidizers Strong acids Strong bases Sodium azide forms explosive compounds with heavy metals. This product contains concentrations of azide<0.1% (w/w) which with repeated contact with lead and copper commonly found in plumbing drains may result in the build up of shock sensitive compounds. Hazardous Decomposition Products No decomposition products posing significant hazards would be expected from this product (a dilute aqueous solution). Conditions to Avoid Keep away from incompatible material. Section 11 Toxicological Information Toxicity Data for Hazardous Ingredients Not applicable 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 Exposure to ProClin 300 may result in irritation of skin, eyes and mucous membranes. Skin contact may result in possible sensitization. Eye contact may cause clouding of the cornea. Ingestion may cause gastrointestinal irritation; large doses given to animals resulted in collapse and coma. This product contains material of animal origin and should be considered as potentially capable of transmitting infectious diseases. Potential Effects of Chronic Exposure Frequent or long­term eye and skin exposure to ProClin 300 may result in conjunctivitis and dermatitis. Symptoms of Overexposure Symptoms may include: coughing, headache, fatigue, nausea, vomiting, dizziness, blurred vision, red and watery eyes, abdominal pain and unconsciousness. Carcinogenicity This product does not contain a reportable concentration (0.1%) of any ingredient listed as carcinogen by ACGIH, IARC, NTP, OSHA or 67/548/EEC Annex I. Other Effects None identified. Conditions Aggravated by Exposure None identified. Section 12 Ecological Information Ecotoxicity No information available. Biodegradability No information available. Mobility No information available. = Page 11 = TESTOSTERONE CALIBRATORS Doc. ID: 33565­75 AC Page 12 of 13 TESTOSTERONE CALIBRATORS S1, S2, S3, S4, and S5 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. Sodium azide preservative may form explosive compounds in metal drain lines. See NIOSH Bulletin: Explosive Azide Hazard (8/16/76). Section 14 Transport Information Transportation of this product is not regulated under ICAO, IMDG, US DOT, European ADR or Canadian TDG. Section 15 Regulatory Information US FederalandStateRegulations SARA 313 Ethylene Oxide 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. Sodium Azide is subject to reporting requirements of Section 313, Title III of SARA. CERCLA RG’s, 40 CFR 302.4 Ethylene Oxide is listed. 1,4­Dioxane is listed. Sodium Azide is listed. California Proposition 65 Testosterone hasbeenidentified bytheState ofCalifornia tocausecancer. TheState of California hasadopted aregulation which requires awarning 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 hasadopted aregulation which requires awarning 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 Testosterone is listed. Ethylene Oxide is listed. 1,4­Dioxane is listed. Sodium Azide is listed. New Jersey Dept. of Health RTK List Testosterone is listed. Ethylene Oxide is listed. 1,4­Dioxane is listed. Sodium Azide is listed. Pennsylvania RTK Testosterone is listed. Ethylene Oxide is listed. 1,4­Dioxane is listed. Sodium Azide is listed. Dipropylene Glycol is listed. = Page 12 = TESTOSTERONE CALIBRATORS Doc. ID: 33565­75 AC Page 13 of 13 TESTOSTERONE CALIBRATORS S1, S2, S3, S4, and S5 Section 15 Regulatory Information (Continued) EU Labeling Classification Classification Risk and Safety Phrases Xi Irritant R43 May cause sensitization by skin contact. S28 After contact with skin, wash immediately with plenty of water. S37 Wear suitable gloves. Canada This product is exempt from WHMIS label and MSDS requirements. PIN: Not applicable Ingredients on Ingredient Disclosure List: Ethylene Oxide 1,4­Dioxane Sodium Azide Ingredients with unknown toxicological properties: Product is exempt Section 16 Other Information * ProClin is a trademark of the Rohm and Haas Company. 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 REPRESENTATIONASTOITSVALIDITY,ACCURACY,ORCURRENCY.BECKMANCOULTERSHALLNOTBELIABLEOROTHERWISERESPONSIBLEINANYWAYFORUSE OFEITHERTHISINFORMATIONORMATERIALSTOWHICHITAPPLIES.DISPOSALOFHAZARDOUSMATERIALSMAYBESUBJECTTOLOCALLAWSORREGULATIONS. Printed in U.S.A. = Page 13 =