1. Identification of the substance/mixture and of the company/undertaking

Transcription

1 1. Identification of the substance/mixture and of the company/undertaking Designation : Pexion, solid (Bulk), <= 72 % Synonyms : Active ingredient: Imepitoin Pexion tablets 25mg, Pexion tablets 50mg, Pexion tablets 100mg, Pexion tablets 400mg, Identified uses : Mixture for production of finished medicinal products. Company : Boehringer Ing. Pharma GmbH & Co.KG Binger Str Ingelheim am Rhein Telephone : / Telefax number : / address : gefahr@boehringer-ingelheim.com Information providing : Quality & Environmental Health & Safety division Emergency information : (+49) (0)61 32 / (24 h) 2. Hazards Identification Classification according to Regulation (EC) No. 1272/2008: Reproductive toxicity, Category 2, Classification (67/548/EWG,1999/45/EG): R63 Possible risk of harm to the unborn child. Labelling according Regulation (EC) No 1272/2008 [CLP]: Pictogram(s) Warning Hazard Statement(s): H361d Suspected of damaging the unborn child. Safety precaution(s): P201 Obtain special instructions before use. P202 Do not handle until all safety precautions have been read and understood. P281 Use personal protective equipment as required. P308 + P313 IF exposed or concerned: Get medical advice/ attention. P405 Store locked up. P501 Dispose of contents/ container to an approved incineration plant Page 1 from 7

2 Labelling according to EEC Directive (67/548/EWG,1999/45/EG): Symbol(s): : Xn Harmful R phrase(s) : R63 Possible risk of harm to the unborn child. S phrase(s) : S36/37/39 Wear suitable protective clothing, gloves and eye/face protection. S53 Avoid exposure - obtain special instructions before use. The pharmacological effect of the medicament has to be considered (see package leaflet). 3. Composition/Information on Ingredients Hazardous ingredients Chemical name Classification GHS classification Concentration 1-(4-Chlorophenyl)-4-(4- morpholinyl)-2,5-dihydro-1himidazolin-2-one Xn; R63 Category 2, H361d <= 72% Molecular formula: C13-H14-Cl-N3-O2 CAS-No Molecular weight: 279,73 Chemical name Classification GHS classification Concentration Non-hazardous galenic >= 28% excipients 4. First-aid Measures General advice : Remove from exposure, lie down. Immediately remove contaminated clothing. First aid personnel should pay attention to their own safety. If danger of loss of consciousness, place patient in recovery position and transport accordingly. Apply artificial respiration if necessary. Eye contact : Rinse immediately with plenty of water for at least 15 minutes. Keep eye wide open while rinsing. Call a physician immediately. Skin contact : Cover wound with sterile dressing. Wash off immediately with plenty of water. Call a physician immediately. Inhalation : Move to fresh air. Call a physician immediately. Ingestion : Rinse mouth. Drink plenty of water. Call a physician immediately Page 2 from 7

3 5. Fire-fighting Measures Suitable extinguishing media : Use extinguishing measures that are appropriate to local circumstances and the surrounding environment., Water, Foam, Carbon dioxide (CO2), Dry chemical Hazards during fire-fighting : In case of fire and/or explosion do not breathe fumes. Can be released in case of fire:, Carbon oxides, nitrogen oxides, Hydrogen chloride gas Protective equipment for fire-fighting : Self-contained breathing apparatus (EN 133) complete suit protecting against chemicals Further information : Fire residues and contaminated fire extinguishing water must be disposed of in accordance with local regulations. Collect contaminated fire extinguishing water separately. This must not be discharged into drains. 6. Accidental Release Measures Personal precautions : Wear personal protective equipment. Refer to protective measures listed in sections 7 and 8. Keep people away from and upwind of spill/leak. Ensure adequate ventilation. Environmental precautions : Do not flush into surface water or sanitary sewer system. Methods for cleaning-up or taking-up : Cleaning operations should be carried out only while wearing breathing apparatus. For large amounts: For residues: Avoid raising dust. Dampen, pick up mechanically and dispose of. Pack in tightly closed containers for disposal. Use approved industrial vacuum cleaner for removal. Additional information : Knock down dust with water spray jet. 7. Handling and Storage Handling Advice on safe handling : Provide sufficient air exchange and/or exhaust in work rooms. Breathing must be protected when large quantities are decanted without local exhaust ventilation. Keep container closed when not in use. Hints for protection against fire and explosion : Keep away from heat and sources of ignition. Take precautionary measures against static discharges. Avoid dust formation. Hygienic measures : General industrial hygiene practice. Wash hands and face before breaks and immediately after handling the product. Keep working clothes separately. Storage Requirements for storage rooms and vessels Advice on storage compatibility Storage class according to VCI : Jointless smooth floor Keep containers tightly closed in a cool, well-ventilated place. Protect from heat and direct sunlight. : Keep away from food, drink and animal feedingstuffs. Advice on Segregation : 11 Combustible Solids Page 3 from 7

4 8. Exposure controls/personal protections Exposure controls Advice on system design : Local exhaust Personal protective equipment Respiratory protection : half mask (EN 140) particle filter P2 (EN 143) Hand protection : Chemical safety glove category III (EN 374). Glove material: Nitrile rubber, Layer thickness: 0.43 mm (f.e. Camatril green, Article No.732, Company KCL). Resistance (permeability): Level 6 (480 min). Eye protection : Safety glasses with side-shields conforming to EN166 Body protection : Laboratory: laboratory coat; factory: chemical protection overall if dust is formed. Additional information : Only use protective equipment in accordance with national/international regulations. Follow the national regulations about wearing personal protective equipment and the warranty given by the manufacturer for the safe function. General protective measures 9. Physical and Chemical Properties : Handle in accordance with good industrial hygiene and safety practice. Do not breathe dust. Avoid contact with skin, eyes and clothing. Form : powder Colour : off-white Odour : odourless Odour threshold ph value Boiling point/boiling range Flash point Ignition temperature Evaporation rate Flammability Lower explosion limit Upper explosion limit Vapour pressure Relative vapour density Relative density Page 4 from 7

5 Partitioning coefficient n- octanol/water (log Pow) Thermal decomposition Explosiveness 10. Stability and Reactivity Hazardous reactions : Dust can form an explosive mixture with air. Conditions to avoid Substances to avoid Hazardous decomposition products 11. Toxicological Information Acute oral toxicity : ALD (ATE) > mg/kg rat (male/female) Acute inhalation toxicity Acute dermal toxicity Repeated dose toxicity : rat NOAEL: 31,6 mg/kg Exposition time: 13 weeks (oral) dog NOAEL: 31,6 mg/kg Exposition time: 13 weeks (oral) dog NOAEL: 90 mg/kg Exposition time: 26 weeks (oral) Skin irritation Eye irritation Sensitization : Non-sensitizing. (guinea pig) Method: Guinea pig maximization test Page 5 from 7

6 Genetic toxicity in vitro : Ames test Salmonella typhimurium Chromosomal aberration test V79 cells (Chinese hamster) HGPRT assay V79 cells (Chinese hamster) Genetic toxicity in vivo : In vivo micronucleus test mouse Carcinogenicity Reproductive toxicity Teratogenicity : rabbit NOAEL Teratog.: 33 mg/kg Aspiration hazard rat Maternal NOAEL: 31,6 mg/kg Showed teratogenic and/or embryotoxic effects in animal experiments. (User Risk Assessment, No. VU "Pexion ", No "Teratogenicity") 12. Ecological information Ecotoxicity Toxicity to fish Toxicity to daphnia Toxicity to algae Toxicity to bacteria Chronic toxicity to fish Chronic toxicity to aquatic invertebrates Persistence and degradability Biological degradation Bioaccumulation Page 6 from 7

7 PBT and vpvb assessment 13. Disposal Considerations Product : Dispose of in accordance with local regulations. Contaminated packaging : Packs that cannot be cleaned should be disposed of in the same manner as the contents. Uncontaminated packaging can be recycled. 14. Transport Information Further information : Not classified as dangerous for conveyance in the meaning of the regulations for the transport of dangerous goods by road and rail. Not classified as dangerous in the meaning of sea and air transport regulations. 15. Regulatory information National legislation/regulations Water hazard class : VWVWS WGK 3 highly water endangering Classification according VwVwS, Annex Other particulars The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information given is designed only as a guidance for safe handling, use, processing, storage, transportation, disposal and release and is not to be considered a warranty or quality specification. The information relates only to the specific material designated and may not be valid for such material used in combination with any other materials or in any process, unless specified in the text Page 7 from 7