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 Synonyms : Active ingredient: Oxitropium Bromide Oxivent metered dose aerosol CFC free, Tersigan metered dose aerosol CFC free 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: The product does not need to be labelled in accordance with EC directives or respective national laws. 3. Composition/Information on Ingredients Hazardous ingredients (1R,2R,4S,5S,7S)-9-Ethyl-7- ((S)-3-hydroxy-2-phenyl- propionyloxy)-9-methyl-3-oxa-9- azonia-tricyclo( ,4)nonane bromide Xn; R20/21/22 Category 4, H332 Category 4, H302 Category 4, H312 0,1 % Molecular formula: C19-H26-BR-N-O4 CAS-No Molecular weight: 412,100 EC-No.: Ethyl alcohol F; R11 Category 2, H225 24,5 % Molecular formula: C2-H6-O CAS-No Molecular weight: 46,07 EC-No.: INDEX-No.: Page 1 from 7

2 1,1,1,2-Tetrafluoroethane (R 134a) 72,7 % Molecular formula: C2-H2-F4 CAS-No Molecular weight: 102,03 EC-No.: Non-hazardous galenic 2,4 % excipients 4. First-aid Measures General advice : Remove from exposure, lie down. Immediately remove contaminated clothing. If danger of loss of consciousness, place patient in recovery position and transport accordingly. Apply artificial respiration if necessary. First aid personnel should pay attention to their own safety. Eye contact : Immediately wash affected eyes for at least 15 minutes under running water with eyelids held open, consult an eye specialist. Skin contact : Wash off thoroughly with ample water. Seek medical attention. 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 : Water, Dry chemical, Foam, carbon dioxide, Use extinguishing measures to suit surroundings. 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 bromide (HBr), Hydrogen fluoride Protective equipment for fire-fighting : Wear self-contained breathing apparatus and chemicalprotective clothing. Further information : Cool endangered containers with water spray jet. Fire or intense heat may cause violent rupture of packages. itself is non-combustible. Dispose of fire debris and contaminated extinguishing water in accordance with official regulations. Collect separately contaminated extinguishing water, do not allow to reach sewage or effluent systems Page 2 from 7

3 6. Accidental Release Measures Personal precautions : Wear protective equipment. Keep unprotected persons away. Ensure adequate ventilation. Environmental precautions : No special environmental precautions required. Methods for cleaning-up or taking-up : Pack in tightly closed containers for disposal. 7. Handling and Storage Handling Advice on safe handling : No hazards which require special first aid measures. Hints for protection against : Keep away from heat and sources of ignition. fire and explosion Hygienic measures : General safety and hygiene measures. Hands and/or face should be washed before breaks and at the end of the shift. Store work clothing separately. 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. : Keep away from food, drink and animal feeding stuffs. Advice on Segregation : 2B Compressed Gas (Aerosol cans) 8. Exposure controls/personal protections Control parameters Ethyl alcohol Components Basis Factor BIEL- Group Values AGW 2(II) 500 ppm 500 ml/m3 960 mg/m3 Remark Y 1,1,1,2-Tetrafluoroethane (R 134a) AGW 8(II) ppm ml/m mg/m3 Y Y = A risk of foetal disease must not be expected with the compliance of AGW and BGW threshold values. Factor = Ceiling limit/exceeding factor Exposure controls Page 3 from 7

4 Personal protective equipment Respiratory protection : Not required; except in case of aerosol formation. 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 : Avoid contact with skin, eyes and clothing. Handle in accordance with good industrial hygiene and safety practice. Form : aerosol Colour : colourless Odour : No data available. Odour threshold : No data available. ph value : No data available. Melting point/ -range : No data available. Boiling point/boiling range : No data available. Flash point : not applicable Ignition temperature : not applicable Evaporation rate : No data available. Flammability : does not ignite Lower explosion limit : not applicable Upper explosion limit : not applicable Vapour pressure : No data available. Relative vapour density : No data available. Relative density : No data available. Solubility in water : No data available. Partitioning coefficient n- octanol/water (log Pow) : No data available. Thermal decomposition : Keep away from sources of ignition - No smoking. Viscosity, dynamic : No data available. Explosiveness : No data available. Further information Density : not applicable Page 4 from 7

5 10. Stability and Reactivity Hazardous reactions : Vapours are flammable. Conditions to avoid : No data available. Substances to avoid : No data available. Hazardous decomposition products : hydrogen halides, Carbonyl halides 11. Toxicological Information Acute oral toxicity : LD50 = mg/kg rat Acute inhalation toxicity : No data available. Acute dermal toxicity : No data available. LD50 = mg/kg rat LD50 = mg/kg mouse Acute toxicity (other route) : LD50 intravenous 44 mg/kg rat Skin irritation : Non-irritant Eye irritation : No eye irritation Sensitization : No data available. Genetic toxicity in vitro : Ames-test Result: negative Genetic toxicity in vivo : Micronucleus assay Result: negative Carcinogenicity : No data available. Reproductive toxicity : No data available. Teratogenicity : No data available. Aspiration hazard : No data available. Assessment of reproduction toxicity Assessment of carcinogenicity : Experiments have shown no reproductive toxicity effects on laboratory animals. : Did not show carcinogenic effects in animal experiments Page 5 from 7

6 Assessment of teratogenicity : Did not show carcinogenic, teratogenic or mutagenic effects in animal experiments. Further information : 12. Ecological information Ecotoxicity Toxicity to fish : No data available. Toxicity to daphnia : No data available. Toxicity to algae : No data available. Toxicity to bacteria : No data available. Chronic toxicity to fish : No data available. Chronic toxicity to aquatic invertebrates : No data available. Persistence and degradability Biological degradation : No data available. Bioaccumulation : No data available. PBT and vpvb assessment : No data available. 13. Disposal Considerations : 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 in the meaning of transport regulations. Use only tightly closed containers. The container must be correctly labelled. Protect container against fall down Page 6 from 7

7 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 7 from 7