SDS-DT-07-02 Heparina de Calcio Ingles.pdf - Syntex

SAFETY DATA SHEETCALCIUM HEPARINIssued date: 01/December/2010 Document: SDS-DT-07-02 Page 1 of 51 Identification of the substance / preparation and of the company / undertaking1.1 Product IdentificationTrade name:Calcium Heparin1.2 Application of the substance / the preparationAnticoagulant.1.3 Manufacturer / Supplier SYNTEX S.A.Luis de Sarro 501 – Luis GuillónBuenos Aires – ArgentinaTel. / Fax: 005411 4290-0609http://www.syntexar.combulk@syntexar.com1.4 Information in case of emergencyIn case of Emergency call (005411)4290 0609 (ARGENTNA)2 Hazards identification2.1 Classification / 2.2 LabelingWarning – May be harmful if swallowed and enter airwaysMay cause damage to the following organs: bloodMay cause irritation to skin, eyes and respiratory tract.Information concerning particular hazards for human and environment:Risk phrases:R20/21/22Harmful by inhalation, in contact with the skin and if swallowedR36/38 Irritating to eyes and skinR43R48R65May cause sensitization by skin contactDanger of serious damage to health by prolonged exposureHarmful: may cause lung damaged if swallowedSafety phrases:S23Do not breathe dust or fumesS24/25 Avoid contact with skin and eyes.3 Composition / information on ingredientsChemical characterizationMucopolysaccharideCAS. Nº Description 37270-89-6SYNTEX S.A.Luis De Sarro 501 - (B1838DQK) – Luis Guillón – Buenos Aires – Argentina – Tel./Fax: (54 11) 4367-6100 syntex@syntexar.com – www.syntexar.com

SAFETY DATA SHEETCALCIUM HEPARINIssued date: 01/December/2010 Document: SDS-DT-07-02 Page 2 of 54 First aid measuresAfter excessive inhalation:Remove exposed person to fresh air (away from aerosolized product). If exposed person is notbreathing, give artificial respiration. If inhalation has resulted in labored breathing, respiratory tractirritation or other symptoms, seek medical attention. Inhalation of used product should beconsidered 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 atleast fifteen minutes. Remove clothing and shoes if in contact with contents of product and washclothing and shoes before reuse. Should irritation of the skin persist, seek medical attention. Nonintactskin 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 andlower lids. Should irritation of the eye(s) persist, seek medical attention. Eye contact with usedproduct should be considered a biohazard exposure incident.After swallowing:Do not induce vomiting unless directed to do so by medical personnel. Never give anything bymouth 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 measures5.1 Suitable extinguishing agentsFor 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 measures6.1 Person – related safety precautions:Wear suitable protective clothing, gloves and eye protection. Ventilate area of leak or spill.6.2 Measures for environmental protectionAvoid dispersing dust into the air. Use non-sparking tools and equipment. Reduce airborne dustand 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 localand 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

SAFETY DATA SHEETCALCIUM HEPARINIssued date: 01/December/2010 Document: SDS-DT-07-02 Page 3 of 56.3 Measures for cleaning / collecting:Avoid dust elevation. Finish cleaning by spreading water on the contaminated surface and disposeof according to local and regional authority requirements.7 Handling and storage7.1 Information for safe handlingKeep container tightly closed. Do not eat, drink or smoke when using this product. Wear protectivegloves 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 and30 º C.8 Exposure control / personal protection8.1 Control parameters:Information about design of technical facilities:Use process enclosures, local exhaust ventilation, or other engineering controls to keep airbornelevels below recommended exposure limits. If user operations generate dust, fume or mist, useventilation to keep exposure to airborne contaminants below the exposure limit.8.2 Exposure control:Personal protective equipment:Eye and RespiratoryprotectionIn case of spillProtection of handsFull suitSplash goggles. Full suit. Dust respirator. Boots. Gloves. A self contained breathing apparatusshould be used to avoid inhalation of the product.9 Physical and chemical propertiesGeneral InformationForm:Color:Odor:Solid (powder)White or off whiteOdorlessChange in conditionMelting point / rangeBoiling point / rangeFlash pointat > 250°C, decomposes with fumes.Not Defined>300°CSYNTEX S.A.Luis De Sarro 501 - (B1838DQK) – Luis Guillón – Buenos Aires – Argentina – Tel./Fax: (54 11) 4367-6100 syntex@syntexar.com – www.syntexar.com

SAFETY DATA SHEETCALCIUM HEPARINIssued date: 01/December/2010 Document: SDS-DT-07-02 Page 4 of 5Ignition temperatureDanger of explosionExplosion limitsVapour pressure at 20 ºCDensity at 20 º CSolubility in / Miscibility withwater at 20 ºCViscosityNot DefinedNot DefinedNot DefinedNot DefinedNot DefinedVery SolubleNot Defined10 Stability and reactivity10.1 ReactivityNot available10.2 Chemical stabilityStable under recommended storage conditions.10.3 Dangerous reactionsOxidizing agents, humidity. Avoid contact with metal surfaces10.4 Conditions to be avoidAvoid extreme temperature and heat.10.5 Incompatible materialsNot available10.6 Dangerous decomposition products:CO x , NO x , SO x , NaO x , Emits toxics fumes under fire conditions.11 Toxicological informationAcute toxicity:LD / LC50 values relevant for classificationOral LD50 > 5000 mg/kg (mice, rats)Primary irritant effectOn the skin: May cause skin irritationOn the eye: May cause eyes irritationSensitization: May cause respiratory tract irritation.May cause damage to the following organs: bloodCMR effects (carcinogenity, mutagenicity and toxicity for reproduction): Not availableSYNTEX S.A.Luis De Sarro 501 - (B1838DQK) – Luis Guillón – Buenos Aires – Argentina – Tel./Fax: (54 11) 4367-6100 syntex@syntexar.com – www.syntexar.com

SAFETY DATA SHEETCALCIUM HEPARINIssued date: 01/December/2010 Document: SDS-DT-07-02 Page 5 of 512 Ecological informationGeneral notes:Not available13 Disposal considerations:13.1 Waste treatmentWaste must be disposed of in accordance with federal, state and local environmental controlregulations14 Transport information14.1 ONU number Not Apply14.2 Proper shipping name Heparin, calcium salt / Solid, organic powder.14.3 Hazard class fortransportationXi Irritant14.4 Packaging group Packing Group III14.5 Hazard for the media Not Apply15 Regulatory information15.1 International regulationsNot Apply15.2 Security evaluation / NFPA ClassificationHEALTH1 May be irritatingFLAMABILITY1 Combustible if heatedREACTIVITY0 Stable. Not reactive when mixed with waterPERSONAL PROTECTION F Required16 Other informationThis information is based on our present knowledge. However, this shall not constitute a guaranteefor any specific product features and shall not establish a legally valid contractual relationship.VersionDescription of the change02 Minor changes for EU compliance with the Regulation N° 453/2010SYNTEX S.A.Luis De Sarro 501 - (B1838DQK) – Luis Guillón – Buenos Aires – Argentina – Tel./Fax: (54 11) 4367-6100 syntex@syntexar.com – www.syntexar.com