Page 1 of 6 MATERIAL SAFETY DATA SHEET Section 1 Company and Product Identication Product Name CORTISOL CALIBRATORS S0, S1, S2, S3, S4, S5 .. Doc. ID: 33605-75 AB . Revised (year/month/day) 2008/01/04 Part Number 33605 Product Use For In Vitro Diagnostic Use. See product literature for details. Series Name ACCESS (r) Manufacturer Beckman Coulter, Inc. 4300 Harbor Blvd. Fullerton, CA 92835-3100, U.S.A. EC REP 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 Hazards Identication Emergency Overview Amber; Clear; Liquid; Musty Nonammable solution. Skin, eye and respiratory tract irritant. Potential sensitizer. Contains material of human 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 human origin and should be considered as potentially capable of transmitting infectious diseases. See Section 11 Toxicological Information for more detailed health information. Potential Environmental Effects No information available. Product Hazard Classications Meets Hazardous Criteria for Preparation/Mixture EU: Xi;R43 . WHMIS: Exempt US OSHA: Not applicable (c)2008 Beckman Coulter, Inc. Global MSDS English Page 2 of 6 Section 3 Composition and Information on Ingredients Hazardous Ingredients: Hazard Classication of Pure Ingredients Chemical Name CAS # EINECS # % by wt. EU WHMIS US OSHA ProClin* 300 Not available Not available <0.5 C;R34 N ;R50-53 T;R23/24/25-43 D2B Corrosive Sensitizer Toxic See Section 15 Regulatory Information for additional information on hazard classications. See Section 16 for Risk Phrases and WHMIS Classication Description. Section 4 First Aid Measures Inhalation If product is inhaled, move exposed individual to fresh air. If individual is not breathing, begin articial 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, ush 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 Flammable Properties Nonammable solution. Extinguishing Media Use extinguishing media suitable for surrounding re. 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 signicant hazard. Protective Equipment for Fireghters Self-contained breathing apparatus is recommended for reghters. 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. CORTISOL CALIBRATORS S0, S1, S2, S3, S4, S5 Doc. ID: 33605-75 AB Page 3 of 6 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 efcacy, 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 NIOSH None established Japan 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 aerosols are generated during use, the use of respiratory protection should be evaluated by a qualied 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 Clear Odor Musty Odor Threshold Not applicable pH 7.2 Freezing Point Not available Boiling Point Not available Flash Point Not applicable Evaporation Rate Not available Flammability (Solid, Gas) Not applicable Flammable Limits Not applicable Vapor Pressure Not available CORTISOL CALIBRATORS S0, S1, S2, S3, S4, S5 Doc. ID: 33605-75 AB Page 4 of 6 Section 9 Physical and Chemical Properties (Continued) Vapor Density Not available Specic Gravity 1.021 @20°C Solubility Water Miscible Organic Not available Coefcient of Water/Oil Distribution Not available Autoignition Temp. Not applicable Decomposition Temperature Not available Percent Volatiles Not applicable 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 signicant hazards would be expected from this product. 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. Specic 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 human 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. CORTISOL CALIBRATORS S0, S1, S2, S3, S4, S5 Doc. ID: 33605-75 AB Page 5 of 6 Section 11 Toxicological Information (Continued) Symptoms of Overexposure Symptoms may include: coughing, headache, fatigue, nausea, vomiting, dizziness, blurred vision, red and watery eyes, abdominal pain and unconsciousness. Carcinogenicity No ingredients in this product are listed as carcinogens by ACGIH, IARC, NTP, OSHA or 67/548/EEC Annex I. Other Effects None identied. Conditions Aggravated by Exposure None identied. Section 12 Ecological Information Ecotoxicity No information available. Biodegradability No information available. Bioaccumulation No information available. Mobility No information available. Other Adverse Effects 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. Section 15 Regulatory Information US Federal and State Regulations SARA 313 Methanol 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 Edetic Acid is listed. Methanol is listed. Sodium Azide is listed. California Proposition 65 No ingredients listed. Massachusetts MSL Edetic Acid is listed. Methanol is listed. Sodium Azide is listed. CORTISOL CALIBRATORS S0, S1, S2, S3, S4, S5 Doc. ID: 33605-75 AB Page 6 of 6 Section 15 Regulatory Information (Continued) New Jersey Dept. of Health RTK List Edetic Acid is listed. Methanol is listed. Sodium Azide is listed. Pennsylvania RTK Edetic Acid is listed. Methanol is listed. Sodium Azide is listed. Dipropylene Glycol is listed. EU Labeling Classication Classication Irritant Risk and Safety Phrases R43 May cause sensitization by skin contact. S28 After contact with skin, wash immediately with plenty of soap and water. S37 Wear suitable gloves. Canada This product is exempt from WHMIS label and MSDS requirements. PIN: Not applicable Ingredients on Ingredient Disclosure List: Methanol Sodium Azide Ingredients with unknown toxicological properties: Product is exempt Some hazardous ingredients listed in Section 15 are below OSHAs and WHMIS' 1.0% w/w (0.1% for carcinogens) or EU's ingredient specic concentrations required for reporting in Section 3. Section 16 Other Information Beckman Coulter Safety 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 Revision Changes Reformatted Sections 2, 3, 5, 8, 9, 12, 15, and 16 per ANSI Z400.1-2004 Standard. Risk Phrases and WHMIS Classication Description From Section 3 R23/24/25 Toxic by inhalation, in contact with skin and if swallowed. R34 Causes burns. R43 May cause sensitization by skin contact. R50 Very toxic to aquatic organisms. R53 May cause long-term adverse effects in the aquatic environment. D2B - Sensitizer - Skin D2B - Skin Or Eye Irritant * 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 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. CORTISOL CALIBRATORS S0, S1, S2, S3, S4, S5 Doc. ID: 33605-75 AB