Issued date: 14/December/2010 SAFETY DATA SHEET LITHIUM HEPARIN Document: SDS-DT-05-02 Page 1 of 5 1 Identification of the substance / preparation and of the company / undertaking 1.1 Product identification Trade name: Lithium Heparin 1.2 Application of the substance / the preparation Anticoagulant. For diagnostic purposes only. It is not for human consumption. 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. 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: 14/December/2010 SAFETY DATA SHEET LITHIUM HEPARIN Document: SDS-DT-05-02 Page 2 of 5 3 Composition / information on ingredients Chemical characterization Mucopolysaccharide CAS. Nº Description 9045-22-1 Identification number(s) EINECS Number: 232-681-7 MDN Number: MFCD00131308 4 First aid measures After inhalation: Remove to fresh air and keep at rest in a position comfortable for breathing. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention. Inhalation of used product should be considered a biohazard exposure incident. After skin contact: Wash with soap and water. Cover the irritated skin with an emollient. Get medical attention if irritation develops. Non-intact skin contact with used product should be considered a biohazard exposure incident. After eye contact: Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Cold water may be used. Get medical attention if irritation occurs. 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 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: 14/December/2010 SAFETY DATA SHEET LITHIUM HEPARIN Document: SDS-DT-05-02 Page 3 of 5 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. 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 to yellow white 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: 14/December/2010 Odor: SAFETY DATA SHEET LITHIUM HEPARIN Document: SDS-DT-05-02 Page 4 of 5 Odorless Change in condition Melting point / range Not Defined Boiling point / range Not Defined Flash point > 300 º C 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 Specific Gravity (H2O=1) 0.7 Solubility in / Miscibility with water at 20 ºC Very soluble Viscosity Not Defined 10 Stability and reactivity 10.1 Reactivity Not apply 10.2 Chemical stability Stable at recommended storage conditions. 10.3 Dangerous reactions Oxidizing agents, humidity 10.4 Conditions to be avoided Avoid extreme temperature and heat. 10.5 Incompatible materials Not apply 10.6 Dangerous decomposition products: COx, NOx, SOx, LiOx, Emits toxics fumes under fire conditions. 11 Toxicological information Acute toxicity: LD / LC50 values relevant for classification Oral LD50 1900 mg / kg (mouses) Primary irritant effect On the skin: May cause skin irritation On the eye: May cause eyes irritation 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: 14/December/2010 SAFETY DATA SHEET LITHIUM HEPARIN Document: SDS-DT-05-02 Page 5 of 5 Sensitization: May cause respiratory tract irritation. CMR effects (carcinogenity, mutagenicity and toxicity for reproduction): Not available 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, lithium 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 Labeling according to EU guidelines: 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