ÿþPage 1 of 13 @Beckman CoulterTM Kit MSDS Doc. ID: 33515-75: Rev. AB Product Information Product Name hLH CALIBRATORS Part Number 33515 Doc. ID 33515-75 AB Issued (year/month/day) Revised (year/month/day) 2003/07/08 Series Name: ACCESSèø Components Description hLH CALIBRATOR S0 hLH CALIBRATORS S1, S2, S3, S4, S5 Transport Information Transportation of this product is not regulated under ICAO, IMDG, US DOT, European ADR or Canadian TDG. éø2003 Beckman Coulter, Inc. Global MSDS  English Page 2 of 13 @Beckman CoulterTM MATERIAL SAFETY DATA SHEET Section 1 Company and Product Identification Product Name hLH CALIBRATOR S0 Part Number Component of P/N 33515 hLH CALIBRATORS Doc. ID 33515-75 AB Issued (year/month/day) Revised (year/month/day) 2003/07/08 Series Name ACCESSèø Manufacturer Beckman Coulter, Inc. 4300 Harbor Blvd. Fullerton, CA 92835-3100, 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 Hazardous Ingredients: Meets Hazardous Criteria: Chemical Name CAS # % by wt. EU US OSHA WHMIS ProClin* 300  <2.0 C;R34 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. Contains material of animal origin. Skin, eye and respiratory tract irritant. 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. See Section 11 Toxicological Information for more detailed health information. Product Hazard Classifications EU: Xi;R43 WHMIS: Exempt US OSHA: Not applicable Beckman Coulter Safety Rating Flammability (Section V): 0 Health (Section XI): 1 Reactivity with Water (Section X): 0 Contact (Section VIII): 2 Code 0=none 1=slight 2=caution 3=severe hLH CALIBRATORS Doc. ID: 33515-75 AB Page 3 of 13 hLH CALIBRATOR S0 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 Flammable Limits Not applicable Autoignition Temp. Not applicable Extinguishing Media Use extinguishing media suitable for surrounding fire. Special Fire and Explosion Hazards No special hazards determined. Hazardous Combustion Products Due to the composition and volume of this product, combustion products generated from it are not expected to present a significant hazard. Protective Equipment for Firefighters Self-contained 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. 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 hLH CALIBRATORS Doc. ID: 33515-75 AB Page 4 of 13 hLH CALIBRATOR S0 Section 8 Exposure Controls and Personal Protection (Continued) 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 latex 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 Specific Gravity 1.035 @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 Metals and metallic compounds Strong oxidizers Perchloric Acid 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 When stored as labeled, no known hazardous decomposition products are formed during the shelf-life of this product. hLH CALIBRATORS Doc. ID: 33515-75 AB Page 5 of 13 hLH CALIBRATOR S0 Section 10 Stability and Reactivity (Continued) 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 long-term 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 (e" 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 Toxic to fish and other water organisms. 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. 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. hLH CALIBRATORS Doc. ID: 33515-75 AB Page 6 of 13 hLH CALIBRATOR S0 Section 15 Regulatory Information US Federal and State Regulations SARA 313 Ethylene Oxide is subject to reporting requirements of Section 313, Title III of SARA. 1,4-Dioxane 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. 1,4-Dioxane 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. 1,4-Dioxane 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 Ethylene Oxide is listed. 1,4-Dioxane is listed. Sodium Azide is listed. New Jersey Dept. of Health RTK List Ethylene Oxide is listed. 1,4-Dioxane is listed. Sodium Azide is listed. Pennsylvania RTK Ethylene Oxide is listed. 1,4-Dioxane is listed. Sodium Azide is listed. EU Labeling Classification Classification Risk and Safety Phrases Xi Irritant R43 May cause sensitization by skin contact. Canada This product is exempt from WHMIS label and MSDS requirements. PIN: Not applicable Ingredients on Ingredient Disclosure List: Ethylene Oxide 1,4-Dioxane Sodium Azide Ingredients with unknown toxicological properties: Product is exempt hLH CALIBRATORS Doc. ID: 33515-75 AB Page 7 of 13 hLH CALIBRATOR S0 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 REPRESENTATION AS TO ITS VALIDITY, ACCURACY, OR CURRENCY. BECKMAN COULTER SHALL NOT BE LIABLE OR OTHERWISE RESPONSIBLE IN ANYWAY 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 8 of 13 @Beckman CoulterTM MATERIAL SAFETY DATA SHEET Section 1 Company and Product Identification Product Name hLH CALIBRATORS S1, S2, S3, S4, S5 Part Number Component of P/N 33515 hLH CALIBRATORS Doc. ID 33515-75 AB Issued (year/month/day) Revised (year/month/day) 2003/07/08 Series Name ACCESSèø Manufacturer Beckman Coulter, Inc. 4300 Harbor Blvd. Fullerton, CA 92835-3100, 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 Hazardous Ingredients: Meets Hazardous Criteria: Chemical Name CAS # % by wt. EU US OSHA WHMIS ProClin* 300  <2.0 C;R34 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. Contains material of human and 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. See Section 11 Toxicological Information for more detailed health information. Product Hazard Classifications EU: Xi;R43 WHMIS: Exempt US OSHA: Not applicable Beckman Coulter Safety Rating Flammability (Section V): 0 Health (Section XI): 1 Reactivity with Water (Section X): 0 Contact (Section VIII): 2 Code 0=none 1=slight 2=caution 3=severe hLH CALIBRATORS Doc. ID: 33515-75 AB Page 9 of 13 hLH CALIBRATORS S1, S2, S3, S4, S5 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 Flammable Limits Not applicable Autoignition Temp. Not applicable Extinguishing Media Use extinguishing media suitable for surrounding fire. Special Fire and Explosion Hazards No special hazards determined. Hazardous Combustion Products Due to the composition and volume of this product, combustion products generated from it are not expected to present a significant hazard. Protective Equipment for Firefighters Self-contained 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 To maintain efficacy, store according to the instructions in the product labeling. Keep away from incompatible material. Section 8 Exposure Controls and Personal Protection Exposure Limits US OSHA: None established hLH CALIBRATORS Doc. ID: 33515-75 AB Page 10 of 13 hLH CALIBRATORS S1, S2, S3, S4, S5 Section 8 Exposure Controls and Personal Protection (Continued) 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 latex 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 Specific Gravity 1.035 @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 Metals and metallic compounds Strong oxidizers Perchloric Acid 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 When stored as labeled, no known hazardous decomposition products are formed during the shelf-life of this product. hLH CALIBRATORS Doc. ID: 33515-75 AB Page 11 of 13 hLH CALIBRATORS S1, S2, S3, S4, S5 Section 10 Stability and Reactivity (Continued) 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 materials of human and animal origin and should be considered as potentially capable of transmitting infectious diseases. Potential Effects of Chronic Exposure Frequent or long-term 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 (e" 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 Toxic to fish and other water organisms. 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. 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. hLH CALIBRATORS Doc. ID: 33515-75 AB Page 12 of 13 hLH CALIBRATORS S1, S2, S3, S4, S5 Section 15 Regulatory Information US Federal and State Regulations SARA 313 Ethylene Oxide is subject to reporting requirements of Section 313, Title III of SARA. 1,4-Dioxane 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. 1,4-Dioxane 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. 1,4-Dioxane 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 Ethylene Oxide is listed. 1,4-Dioxane is listed. Sodium Azide is listed. New Jersey Dept. of Health RTK List Ethylene Oxide is listed. 1,4-Dioxane is listed. Sodium Azide is listed. Pennsylvania RTK Ethylene Oxide is listed. 1,4-Dioxane is listed. Sodium Azide is listed. EU Labeling Classification Classification Risk and Safety Phrases Xi Irritant R43 May cause sensitization by skin contact. Canada This product is exempt from WHMIS label and MSDS requirements. PIN: Not applicable Ingredients on Ingredient Disclosure List: Ethylene Oxide 1,4-Dioxane Sodium Azide Ingredients with unknown toxicological properties: Product is exempt hLH CALIBRATORS Doc. ID: 33515-75 AB Page 13 of 13 hLH CALIBRATORS S1, S2, S3, S4, S5 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 REPRESENTATION AS TO ITS VALIDITY, ACCURACY, OR CURRENCY. BECKMAN COULTER SHALL NOT BE LIABLE OR OTHERWISE RESPONSIBLE IN ANYWAY 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.