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 : Lendormin, solid (Bulk), <= 1% Synonyms : Active ingredient: Brotizolam Lendormin 0,25mg tablets<(>,<)> Noctilan, Lindormin<(>,<)> Lendormin 0,25mg comresse, Lendormin D tablets 0,25mg, Lendorm, Ledormine, Lendormin tabletta 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: This product is a non-hazardous mixture of single components and need not be labelled according to EC-Directive 1999/45/EC, as amended. 3. Composition/Information on Ingredients Hazardous ingredients Chemical name Classification GHS classification Concentration 2-Bromo-4-(2-chlorophenyl)-9- methyl-6h-thieno(3,2- f)(1,2,4)triazolo(4,3- a)(1,4)diazepine <= 1% Molecular formula: C15-H10-Br-Cl-N4-S CAS-No Molecular weight: 393,700 EC-No.: Chemical name Classification GHS classification Concentration Non-hazardous galenic >= 99% excipients Page 1 from 6

2 4. First-aid Measures General advice : Remove from exposure, lie down. Do not leave affected persons unsupervised. First aid personnel should pay attention to their own safety. Seek medical treatment. Eye contact : Immediately wash affected eyes for at least 15 minutes under running water with eyelids held open, consult an eye specialist. Skin contact : Immediately wash thoroughly with plenty of water, apply sterile dressings, consult a skin specialist. Inhalation : Keep patient calm, remove to fresh air, seek medical attention. Ingestion : Rinse mouth immediately and then drink plenty of water, seek medical attention. Notes to physician Treatment : Observe the summary of product characteristics of proprietary medicinal products 5. Fire-fighting Measures Suitable extinguishing media : Use extinguishing measures to suit surroundings., Water, Dry chemical, Foam, carbon dioxide Hazards during fire-fighting : In case of fire and/or explosion do not breathe fumes. Can be released in case of fire:, Carbon oxides, Hydrogen bromide (HBr), nitrogen oxides, hydrogen chloride, Sulphur oxides Protective equipment for fire-fighting : In case of fire and/or explosion do not breathe fumes. Selfcontained breathing apparatus. Further information : Dispose of fire debris and contaminated extinguishing water in accordance with official regulations. 6. Accidental Release Measures Personal precautions : Wear protective equipment. Keep unprotected persons away. Avoid creating dust. Environmental precautions : Do not discharge into drains/surface waters/groundwater. Methods for cleaning-up or taking-up : Cleaning operations should be carried out only while wearing breathing apparatus. For large amounts: Dampen, pick up mechanically and dispose of. Avoid raising dust. For residues: Use approved industrial vacuum cleaner for removal. Pack in tightly closed containers for disposal. Additional information : Never return spills in original containers for re-use. 7. Handling and Storage Handling Advice on safe handling : Ensure thorough ventilation of stores and work areas. Breathing must be protected when large quantities are decanted without local exhaust ventilation. Do not open until use Page 2 from 6

3 Hygienic measures : General safety and hygiene measures. Hands and/or face should be washed before breaks and at the end of the shift. Storage Requirements for storage rooms and vessels Advice on storage compatibility Storage class according to VCI : Store in original container. Protect from heat and direct sunlight. Jointless smooth floor Keep container tightly closed. : Keep away from food, drink and animal feedingstuffs. Advice on Segregation : 11 Combustible Solids 8. Exposure controls/personal protections Exposure controls Advice on system design : Use with local exhaust ventilation. Personal protective equipment Respiratory protection : Use breathing apparatus if exposed to vapours/dust/aerosol. 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). Eye protection : Safety glasses with side-shields (frame goggles) (EN 166) Body protection : Laboratory: laboratory coat; factory: disposable Overall. 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 : solid granular Colour Odour Odour threshold ph value Melting point/ -range Boiling point/boiling range : not applicable Flash point : not applicable Ignition temperature Page 3 from 6

4 Evaporation rate Flammability Lower explosion limit Upper explosion limit Vapour pressure : not applicable Relative vapour density Relative density Solubility in water Partitioning coefficient n- octanol/water (log Pow) Thermal decomposition Explosiveness Peroxides Further information Minimum ignition energy 10. Stability and Reactivity Conditions to avoid Substances to avoid Hazardous decomposition products 11. Toxicological Information Acute oral toxicity : LD50 > mg/kg rat Acute inhalation toxicity Acute dermal toxicity Skin irritation : Non-irritant (rabbit) Eye irritation Sensitization Genetic toxicity in vitro : Ames-test Page 4 from 6

5 Chromosomal aberration test Genetic toxicity in vivo : Cytogenetic assay Chinese hamster Carcinogenicity Reproductive toxicity Teratogenicity Assessment of carcinogenicity Micronucleus assay mouse : Did not show carcinogenic effects in animal experiments., The values mentioned are those of the active ingredient. Further information : Danger of reduced reaction capability (sedativum) at low dosages., The values mentioned are those of the active ingredient. 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 Transport between environmental compartments Bioaccumulation : No appreciable bioaccumulation potential is to be expected (log P(o/w) 1-3)., The values mentioned are those of the active ingredient Page 5 from 6

6 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 (Brotizolam) (Brotizolam) 15. Regulatory information National legislation/regulations Water hazard class : VWVWS WGK 2 water endangering Annex 4 VwVwS (Germany) dated Mai, 17 th 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 6 from 6