Issued date: 01/December/2010 SAFETY DATA SHEET CALCIUM HEPARIN Document: SDS-DT-07-02 Page 1 of 5 1 Identification of the substance / preparation and of the company / undertaking 1.1 Product Identification Calcium Heparin Trade name: 1.2 Application of the substance / the preparation Anticoagulant. 1.3 Manufacturer / Supplier SYNTEX S.A. Luis de Sarro 501 – Luis Guillón Buenos Aires – Argentina Tel. / Fax: 005411 4290-0609 http://www.syntexar.com bulk@syntexar.com 1.4 Information in case of emergency In case of Emergency call (005411)4290 0609 (ARGENTNA) 2 Hazards identification 2.1 Classification / 2.2 Labeling Warning – May be harmful if swallowed and enter airways May cause damage to the following organs: blood May cause irritation to skin, eyes and respiratory tract. Information concerning particular hazards for human and environment: Risk phrases: R20/21/22 Harmful by inhalation, in contact with the skin and if swallowed R36/38 Irritating to eyes and skin R43 May cause sensitization by skin contact R48 Danger of serious damage to health by prolonged exposure R65 Harmful: may cause lung damaged if swallowed Safety phrases: S23 Do not breathe dust or fumes S24/25 Avoid contact with skin and eyes. 3 Composition / information on ingredients Chemical characterization Mucopolysaccharide CAS. Nº Description 37270-89-6 SYNTEX S.A. Luis De Sarro 501 - (B1838DQK) – Luis Guillón – Buenos Aires – Argentina – Tel./Fax: (54 11) 4367-6100 syntex@syntexar.com – www.syntexar.com Issued date: 01/December/2010 SAFETY DATA SHEET CALCIUM HEPARIN Document: SDS-DT-07-02 Page 2 of 5 4 First aid measures After excessive inhalation: Remove exposed person to fresh air (away from aerosolized product). If exposed person is not breathing, give artificial respiration. If inhalation has resulted in labored breathing, respiratory tract irritation or other symptoms, seek medical attention. Inhalation of used product should be considered a biohazard exposure incident. After skin contact: In case of skin contact with contents of product wash the area with plenty of soap and water for at least fifteen minutes. Remove clothing and shoes if in contact with contents of product and wash clothing and shoes before reuse. Should irritation of the skin persist, seek medical attention. Nonintact skin contact with used product should be considered a biohazard exposure incident. After eye contact: Immediately flush eye(s) with water for at least fifteen minutes occasionally lifting the upper and lower lids. Should irritation of the eye(s) persist, seek medical attention. Eye contact with used product should be considered a biohazard exposure incident. After swallowing: Do not induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. Wash mouth. If large quantities of this material are swallowed, call a physician immediately. Loosen tight clothing such as collar, tie, belt or waistband. 5 First-fighting measures 5.1 Suitable extinguishing agents For small fire use dry chemical powder. For large fire use water spray, fog or foam. 5.2 For safety reasons unsuitable extinguishing agents: Do not use water jet. 5.3 Protective equipment: Be sure to use an approved/certified respirator or equivalent. 6 Accidental release measures 6.1 Person – related safety precautions: Wear suitable protective clothing, gloves and eye protection. Ventilate area of leak or spill. 6.2 Measures for environmental protection Avoid dispersing dust into the air. Use non-sparking tools and equipment. Reduce airborne dust and prevent scattering by moistening with water. Small spill: Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and dispose of according to local and regional authority requirements. Large spill and leak: Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface. SYNTEX S.A. Luis De Sarro 501 - (B1838DQK) – Luis Guillón – Buenos Aires – Argentina – Tel./Fax: (54 11) 4367-6100 syntex@syntexar.com – www.syntexar.com Issued date: 01/December/2010 SAFETY DATA SHEET CALCIUM HEPARIN Document: SDS-DT-07-02 Page 3 of 5 6.3 Measures for cleaning / collecting: Avoid dust elevation. Finish cleaning by spreading water on the contaminated surface and dispose of according to local and regional authority requirements. 7 Handling and storage 7.1 Information for safe handling Keep container tightly closed. Do not eat, drink or smoke when using this product. Wear protective gloves and face protection. Avoid extreme temperature and heat. 7.2 Information about storage: Keep container in a well ventilated and dry area at room temperature, preferable between 10 and 30 º C. 8 Exposure control / personal protection 8.1 Control parameters: Information about design of technical facilities: Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommended exposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure to airborne contaminants below the exposure limit. 8.2 Exposure control: Personal protective equipment: Eye and Respiratory protection Protection of hands Full suit In case of spill Splash goggles. Full suit. Dust respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoid inhalation of the product. 9 Physical and chemical properties General Information Form: Solid (powder) Color: White or off white Odor: Odorless Change in condition Melting point / range at > 250°C, decomposes with fumes. Boiling point / range Not Defined Flash point >300°C SYNTEX S.A. Luis De Sarro 501 - (B1838DQK) – Luis Guillón – Buenos Aires – Argentina – Tel./Fax: (54 11) 4367-6100 syntex@syntexar.com – www.syntexar.com Issued date: 01/December/2010 SAFETY DATA SHEET CALCIUM HEPARIN Document: SDS-DT-07-02 Ignition temperature Not Defined Danger of explosion Not Defined Explosion limits Not Defined Vapour pressure at 20 ºC Not Defined Density at 20 º C Not Defined Solubility in / Miscibility with water at 20 ºC Very Soluble Viscosity Not Defined Page 4 of 5 10 Stability and reactivity 10.1 Reactivity Not available 10.2 Chemical stability Stable under recommended storage conditions. 10.3 Dangerous reactions Oxidizing agents, humidity. Avoid contact with metal surfaces 10.4 Conditions to be avoid Avoid extreme temperature and heat. 10.5 Incompatible materials Not available 10.6 Dangerous decomposition products: COx, NOx, SOx, NaOx, Emits toxics fumes under fire conditions. 11 Toxicological information Acute toxicity: LD / LC50 values relevant for classification Oral LD50 > 5000 mg/kg (mice, rats) Primary irritant effect On the skin: May cause skin irritation On the eye: May cause eyes irritation Sensitization: May cause respiratory tract irritation. May cause damage to the following organs: blood CMR effects (carcinogenity, mutagenicity and toxicity for reproduction): Not available SYNTEX S.A. Luis De Sarro 501 - (B1838DQK) – Luis Guillón – Buenos Aires – Argentina – Tel./Fax: (54 11) 4367-6100 syntex@syntexar.com – www.syntexar.com Issued date: 01/December/2010 SAFETY DATA SHEET CALCIUM HEPARIN Document: SDS-DT-07-02 Page 5 of 5 12 Ecological information General notes: Not available 13 Disposal considerations: 13.1 Waste treatment Waste must be disposed of in accordance with federal, state and local environmental control regulations 14 Transport information 14.1 ONU number Not Apply 14.2 Proper shipping name Heparin, calcium salt / Solid, organic powder. 14.3 Hazard class for transportation Xi Irritant 14.4 Packaging group Packing Group III 14.5 Hazard for the media Not Apply 15 Regulatory information 15.1 International regulations Not Apply 15.2 Security evaluation / NFPA Classification HEALTH FLAMABILITY REACTIVITY PERSONAL PROTECTION 1 1 0 F May be irritating Combustible if heated Stable. Not reactive when mixed with water Required 16 Other information This information is based on our present knowledge. However, this shall not constitute a guarantee for any specific product features and shall not establish a legally valid contractual relationship. Version Description of the change 02 Minor changes for EU compliance with the Regulation N° 453/2010 SYNTEX S.A. Luis De Sarro 501 - (B1838DQK) – Luis Guillón – Buenos Aires – Argentina – Tel./Fax: (54 11) 4367-6100 syntex@syntexar.com – www.syntexar.com