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: Ipratropium bromide and Fenoterol hydrobromide Berodual HFA MDI, Berodual N, Berodual HFA, Duovent HFA, Berodual Dosis-Aerosol (CFC-free), Berodual PA, Berodual Metered Aerosol (HFA), Berodual N, Inhalációs Aeroszol, Berodual N, Aerosol solutie de inhalat, Berodual HFA Metcf/10 ml 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: The product does not require a hazard warning label in accordance with EC directives/the relevant national laws. 3. Composition/Information on Ingredients Hazardous ingredients 3-(3-hydroxy-1-oxo-2- phenylpropoxy)-8-methyl-8-(1- methylethyl)-8- azoniabicyclo(3.2.1)octane bromide monohydrate Xn; R22 Category 4, H302 <= 0,04% Molecular formula: C20-H30-N-O3-BR x H2O CAS-No Molecular weight: 430, Page 1 from 9

2 1-(3,5-Dihydroxyphenyl)-2-((1- (4- hydroxybenzyl)ethyl)amino)etha nol Hydrobromide R51/53 Category 2, H411 <= 0,01% Molecular formula: C17-H21-N-O4 X HBR CAS-No Molecular weight: 384,27 EC-No.: Ethyl alcohol F; R11 Category 2, H225 <= 25% Molecular formula: C2-H6-O CAS-No Molecular weight: 46,07 EC-No.: INDEX-No.: Reg. No.: XXXX 1,1,1,2-Tetrafluoroethane (R <= 74% 134a) Molecular formula: C2-H2-F4 CAS-No Molecular weight: 102,03 EC-No.: Non-hazardous galenic <= 0,95% 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 : Rinse immediately with plenty of water for at least 15 minutes. Keep eye wide open while rinsing. Call a physician immediately. Skin contact : No hazards anticipated. Inhalation : Move to fresh air. If symptoms persist, call a physician. Ingestion : Swallowing is not regarded as possible way of exposition. Notes to physician Treatment : Observe the summary of product characteristics of proprietary medicinal products Page 2 from 9

3 5. Fire-fighting Measures Suitable extinguishing media : Use extinguishing measures that are appropriate to local circumstances and the surrounding environment., Water, Dry chemical, Foam, Carbon dioxide (CO2) Hazards during fire-fighting : In case of fire and/or explosion do not breathe fumes. Can be released in case of fire:, Hydrogen fluoride, Carbon oxides, Hydrogen bromide (HBr), nitrogen oxides (NOx) Protective equipment for fire-fighting : In case of fire and/or explosion do not breathe fumes. Selfcontained breathing apparatus (EN 133) 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. 6. Accidental Release Measures Personal precautions : Wear personal protective equipment. Refer to protective measures listed in sections 7 and 8. Environmental precautions : No special environmental precautions required. Methods for cleaning-up or taking-up : Allow to evapourate. Pick up and transfer to properly labelled containers. 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 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 : 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) Page 3 from 9

4 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 Factor = Ceiling limit/exceeding factor Exposure controls Personal protective equipment Respiratory protection : No personal respiratory protective equipment normally required. Eye protection : Safety glasses with side-shields conforming to EN166 Body protection : Protective work clothing 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 : No data available. Evaporation rate : No data available Page 4 from 9

5 Flammability : does not ignite Lower explosion limit : No data available. Upper explosion limit : No data available. Vapour pressure : hpa at 50 C 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., Heating can release hazardous gases. Viscosity, dynamic : No data available. Explosiveness : No data available. Peroxides : No data available. Further information Density : not applicable 10. Stability and Reactivity Stability : No decomposition if stored and applied as directed. Hazardous reactions : Conditions to avoid : Extremes of temperature and direct sunlight. Substances to avoid : not applicable Hazardous decomposition products : Hydrogen fluoride, Fluorine phosgene 11. Toxicological Information Acute oral toxicity : LD50 = mg/kg rat (male/female) LD50 = 1.600,000 mg/kg rat (male) Acute inhalation toxicity : LC50 > 5 µg/l Exposition time: 4 h, rat Page 5 from 9

6 Acute dermal toxicity : No data available. Skin irritation : Non-irritant (rabbit) Eye irritation : No eye irritation (rabbit) Sensitization : Non-sensitizing. (guinea pig) Did not cause sensitisation on laboratory animals. Genetic toxicity in vitro : Ames-test Salmonella typhimurium Result: negative Ames-test Result: negative HGPRT assay V79 cells (Chinese hamster) Result: negative Genetic toxicity in vivo : Micronucleus assay mouse Result: negative The values mentioned are those of the active ingredient. Carcinogenicity : No data available. Teratogenicity : No data available. Assessment of reproduction toxicity Assessment of reproduction toxicity : Experiments have shown no reproductive toxicity effects on laboratory animals., The values mentioned are those of the active ingredient. : Experiments have shown no reproductive toxicity effects on laboratory animals., The values mentioned are those of the active ingredient Page 6 from 9

7 12. Ecological information Ecotoxicity Toxicity to fish : No data available. Toxicity to daphnia : NOEC = 3,16 mg/l (Daphnia magna) Exposition time: 21 d Lowest observed effect concentration = 10 mg/l (Daphnia magna) Exposition time: 21 d EC50 > 100 mg/l (Daphnia) Exposition time: 48 h Method: OECD Test Guideline 202 (Fenoterol hydrobromide) Toxicity to algae : EC50 (yield) = 7 mg/l (Algae) Method: Algae, Growth Inhibition Test EC50 (Growth rate) = 54 mg/l (Algae) The details of the toxic effect relate to the nominal concentration., Toxicity to bacteria : NOEC = 200 mg/l (activated sludge) Chronic toxicity to aquatic invertebrates NOEC = mg/l (activated sludge, industrial) EC50 = 700,5 mg/l (activated sludge) Method: OECD 209 : No data available. Persistence and degradability Biological degradation : Not readily biodegradable. ca. 37 % Exposition time: 47 d Biological degradation : Not readily biodegradable. 2 % Exposition time: 28 d Method: OECD 301 D Guideline Page 7 from 9

8 Transport between environmental compartments : No data available. Bioaccumulation : Accumulation in organisms is not to be expected., The values mentioned are those of the active ingredient. Bioaccumulation : No appreciable bioaccumulation potential is to be expected (log P(o/w) 1-3)., The values mentioned are those of the active ingredient. PBT and vpvb assessment : No data available. 13. Disposal Considerations : Dispose of in accordance with local regulations. Contaminated packaging : Uncontaminated packaging can be recycled. 14. Transport Information Further information : Not classified as dangerous in the meaning of transport regulations. 15. Regulatory information National legislation/regulations Water hazard class : VWVWS WGK 1 slightly water endangering Annex 4 VwVwS (Germany) dated Mai, 17 th Page 8 from 9

9 16. 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 9 from 9