1.2. Relevant identified uses of the substance or mixture, and uses advised against

Transcription

1 1. PRODUCT AND COMPANY IDENTIFICATION 1.1. Product identifier Part code Trade name Packaging Anticoagulant Human Plasma 6-PPAOL Oral INR < 2 1 ml 6-PPAOM Oral INR ml 6-PPAOH Oral INR ml 6-PPAOUH Oral INR > 4 1 ml 6-PPFRAG Low Molecular Weight Heparin (LMWH) Fragmin (U/mL) 1 ml 6-PPLOV Low Molecular Weight Heparin (LMWH) Lovenox (U/mL) 1 ml 6-PPINNO Low Molecular Weight Heparin (LMWH) Innohep (U/mL) 1 ml 6-PPFOND New Oral Anticoagulant (NOAC) Fondaparinux (Arixtra ) (U/mL) 1 ml 6-PPARG DTI Argatroban U/mL 1 ml 6-PPLEP DTI Lepirudin U/mL 1 ml 6-PPBIV DTI Bivalirudin U/mL 1 ml 1.2. Relevant identified uses of the substance or mixture, and uses advised against Recommanded use : Use advised against : - Laboratory reagents 1.3. Company identification Manufacturer / Distributor : Cryopep 83 rue Yves Montand, Montpellier, France Tel : Fax : contact@cryopep.com 1.4. Emergency phone NVIC (NL) : Tél. : ANTIGIFCENTRUM (B) : Tél. : HAZARDS IDENTIFICATION 2.1. Product classification Not dangerous R Phrase : 2.2. Labelling Elements Hazard statements : Safety advice : 2.3. Other hazards Major hazards : Potential health effects : Eyes : Skin : Ingestion : Inhalation : Biological risks All blood products should be treated as potentially infectious. Source material from which this product was derived was found to be negative when tested in accordance with current FDA required tests (antibodies to HIV, HCV, HBsAg). No known test methods c May cause irritations. Can enter in the circulatory system through an open wound. May cause abdominal pain, nausea and vomiting. May cause respiratory tract irritation. Page 1 / 6

2 3. COMPONENT / INFORMATIONS ON INGREDIENTS 3.1. Product description Human plasma 3.2. Hazardous components N CAS Name Concentration Symbol Risk 4. FIRST AID MEASURES 4.1. Description of first aid measures Inhalation : Skin contact : Eye contact : Ingestion : Move person to fresh air. In case of shortness of breath, give oxygen. Get medical advice. Wash thoroughly skin with water and soap or decontaminating solution. Remove contaminated clotihng. Wash immediately eyes and rinse with water including under the eyelids at least 15 minutes. Get medical advice. Rinse mouth with plenty water and spit out provided person is conscious. Drink water. Get immediately a medical advice. 5. FIRE FIGHTING MEASURES 5.1. Suitable extinguishing media Suitable extinguishing media : Use extinguishing media appropriate for surrounding fire Unsuitable extinguishing media : 5.2. Special hazards arising from the product No specific risk No specific risk 5.3. Fire fighting instructions Wear an independent respirator and protective clothing to fire fighting with chemical or biological products. 6. ACCIDENTAL RELEASE MEASURES 6.1. Personal precautions, protective equipment and emergency procedures Wear a lab coat, protective gloves and safety glasses. Wash immediately contaminated clothing Environment precautions Do not discharge into the environment. Do not flush into surface water or sanitary sewer system Methods and material for containment and cleaning up Ventilate the room. Sweep product.wash immediatly with water in accordance with godd laboratory practices. Dispose in accordance with local regulations. Place contaminated materials in an approved container for proper disposal, in accordance with local regulations Reference to other sections See sections 7, 8 and 13. Page 2 / 6

3 7. HANDLING AND STORAGE 7.1. Precautions for safe handling Use in ventilated area. Wear personal protective equipment (lab coat, protective gloves, safety glasses). Avoid eye and skin contact. Wash hands after use. Remove potentially-contaminated lab coats before enter in refreshment area Conditions for safe storage, including any incompatibilities Store product in tightly closed vial to avoid accidental leakage or spreading at temperature indicated on the certificate of analysis Specific End Uses Use in labs. 8. EXPOSURE CONTROL / PERSONAL PROTECTION 8.1. Exposure parameters Exposure limit Product as shipped do not contain hazardous materials of which occupational exposure limits have not been made by the local specific regulatory organization Valeurs limites biologiques Product as shipped do not contain hazardous materials of which biological limit values have not been made by the local specific regulatory organization Monitoring method Derived no-effect level (DNEL) Predicted no-effect concentration (PNEC) 8.2. Exposure controls Technical measures Ensure adequate ventilation, especially in confined areas. Ensure that eyewash stations and safety showers are close to the workstation location Individual protection measures, such as personal protective equipment. Eye / face protection Chemical safety glasses (European standard EN166) Hand protection Protective gloves (European standard EN 374) Inspect gloves before use. Respect permeability and penetration time instructions through gloves defined by the manufacturer Use gloves appropriate for work or task being performed (chemical compatibility, dexterity, experimental conditions, ). Take account of regional and local conditions of use. Be careful when remove gloves to avoid self-contamination. Skin and body protection Respiratory protection Wear suitable protective clothing and gloves to prevent skin exposure Health safety Handle in accordance with good laboratory hygiene Environmental exposure controls Page 3 / 6

4 9. PHYSICAL AND CHEMICAL PROPERTIES 9.1. Information on basic physical and chemical properties Appearence : Pale yellow liquid after thawing Odor : Light plasmatic odour Odor threshold : ph (between 20 and 25 C) : 6-8 Melting point : Boiling point : Boiling ranges : Flash point : Evaporation rate : Flammability (solid, gaz) : Explosion limit : Vapor pressure : Vapor density : Specific gravity : Solubility : Full in water Partition coefficient : Self ingnition : Decompositiontemperature : Viscosity : Explosive properties : Oxidising properties : 9.2. Other informations 10. STABILITY AND REACTIVITY Reactivity known under normal use Chemical Stability Stable in normal conditions Possibility of hazardous reactions Hazardous polymerization : Hazardous Reactions : Conditions to avoid known Incompatible materials known Page 4 / 6

5 10.6. Hazardous decomposition products 11. TOXICOLOGICAL INFORMATIONS Informations on toxological effects Acute toxicity Skin corrosion / irritation Serious eye damage Respiratory sensibilisation Skin sensibilisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity Specific target organ toxicity (single exposure) Specific target organ toxicity (repeated exposure) Aspiration hazard Other adverse effects The above health effects are based on extrapolation of data for pure product substances. No effect was reported under normal conditions of use, ie, as a mixture of these compounds. However, these effects have not been fully investigated. All blood products should be treated as potentially infectious. No known test methods can offer assurance that products derived from human blood will not transmit infectious agents Symptoms and effects, both acute and delayed 12. ECOLOGICAL INFORMATIONS Toxicity Persistence and degradability Product miscible with water, rapidly degradable and biodegradable Bioaccumulative potential known Mobility in soil Results of PBT and vpvb assessment Page 5 / 6

6 12.6. Other adverse effects 13. DISPOSAL CONSIDERATIONS Waste treatment methods The product must be disposed of as laboratory chemical in suitable containers and in accordance with local regulations Waste from residues / unused products The product must be disposed of as laboratory chemical in suitable containers and in accordance with local regulations Contaminated packaging Packaging should be disposed in suitable containers in accordance with local regulations. 14. TRANSPORT INFORMATIONS (INTERNATIONAL REGULATIONS) Sea transport (IMDG / IMO) Not applicable Land transport (ADR) Not applicable Air transport (IATA) Not applicable 15. REGULATORY INFORMATIONS Symbole : Risk phrases R : Risk phrases S : S 20/21 When using do not eat, drink or smoke S 24/25 S 29/56 S 36/37/39 S 64 Other regulatory requirements : Avoid contact with skin and eyes Do not empty into drains, dispose of this material and its container at hazardous or special waste collection point Wear suitable protective clothing, gloves and eye/face protection If swalled, rinse mouth with water (only if the person is conscious) This document does not in any way excuse the user from knowing and applying all national and international regulations of its activity 16. OTHER INFORMATION This document complements the technical sheets but does not replace it. The information contained herein is based on the state of our knowledge of the product, at the date indicated. They are given in good faith. In addition, we draw the attention of the user to the possible risks incurred when a product is used for purposes other than those for which it is designed. The user must accept the sole responsibility in the matter and take the necessary precautions when using this product. 17. REVISION Version Date Modifications 2015/11 05/11/2015 Creation Page 6 / 6