Molecular formula: C23-H27-Cl-O7 CAS-No Molecular weight: 450,91

Transcription

1 1. Identification of the substance/mixture Designation : Jardiance Synonyms : Active ingredient: Empagliflozin Identified uses : Pharmaceutical Product Company : Boehringer-Ingelheim Pharmaceuticals, Incorpoed 900 Ridgebury Road Ridgefield, Connecticut Emergency Contact : CHEMTREC Emergency Phone Number Number Routine Contact Number : (203) Hazards Identification This product is a non-hazardous mixture of single components. This is a pharmaceutical product, designed to be prescribed by a licensed health care professional. 3. Composition/Information on Ingredients Hazardous ingredients Chemical name Classification GHS classification Concention (2S,3R,4R,5S,6R)-2-(4-Chloro- 3-{4-[(S)-(tetrahydro-furan-3- yl)oxy]-benzyl}-phenyl)-6- hydroxymethyl-tetrahydropyran-3,4,5-triol >= 25% Molecular formula: C23-H27-Cl-O7 CAS-No Molecular weight: 450,91 Chemical name Classification GHS classification Concention Non-hazardous galenic <= 75% 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 respiion 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 : Wash off immediately with plenty of water. Cover wound with sterile dressing. Call a physician immediately. Inhalation : Move to fresh air. Call a physician immediately. Page 1 from 6

2 Ingestion : Rinse mouth. Drink plenty of water. Call a physician immediately. Notes to physician Treatment : Observe the summary of product characteristics of proprietary medicinal products 5. Fire-fighting Measures Suitable extinguishing media : Use extinguishing measures that are appropriate to local circumstances and the surrounding environment., Carbon dioxide (CO2), Water, Dry chemical, Foam 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 chloride Protective equipment for fire-fighting : Self-contained breathing appaus (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 sepaely. 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 : 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 : Do not open until use. Provide good ventilation of working area (local exhaust ventilation if necessary). Keep away from sources of ignition - No smoking. Protect from moisture. Hints for protection against fire and explosion : Keep away from heat and sources of ignition. Take precautionary measures against static discharges. 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 sepaely. Storage Requirements for storage rooms and vessels Advice on storage compatibility Storage class : 11 Combustible Solids : Keep tightly closed in a dry and cool place. Keep in a wellventilated place. Protect from heat and direct sunlight. Jointless smooth floor : Keep away from food, drink and animal feed. Advice on Segregation Page 2 from 6

3 8. Exposure controls/personal protections Control parameters Components Basis Factor BIEL- Group (2S,3R,4R,5S,6R)-2-(4- Chloro-3-{4-[(S)- (tetrahydro-furan-3-yl)oxy]- benzyl}-phenyl)-6- hydroxymethyl-tetrahydropyran-3,4,5-triol Values BIEL µg/m3 BIPC: 1b BIEL = Boehringer Ingelheim Exposure Limit / BIPC = Boehringer Ingelheim Pregnancy Category Factor = Ceiling limit/exceeding factor Remark Exposure controls Personal protective equipment Respiory protection : Use breathing appaus if exposed to vapors/dust/aerosol. half mask particle filter. Hand protection : Chemical safety glove. Glove material: Nitrile rubber, Layer thickness: 0.43 mm. Eye protection : Safety glasses with side-shields. Body protection : Laboory: laboory coat. 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 Form : solid Color : No data available. Odor : No data available. Odor threshold : no data available ph value : No data available. Melting point/range : No data available. Boiling point/boiling range : No data available. Flash point : No data available. Ignition tempeure : No data available. Evapoion e : No data available. Flammability : No data available. Lower explosion limit : No data available. Upper explosion limit : No data available. Vapor pressure : No data available. : Handle in accordance with good industrial hygiene and safety practice. Do not breathe dust. Avoid contact with skin, eyes and clothing. Page 3 from 6

4 Relative vapor density : not applicable Relative density : No data available. Solubility in water : No data available. Partitioning coefficient n- octanol/water (log Pow) : No data available. Self-ignition tempeure : No data available. Thermal decomposition : No data available. Viscosity, dynamic : not applicable Further information Minimum ignition energy : No data available. Bulk density : No data available. 10. Stability and Reactivity Hazardous reactions : Accumulation of fine dust may entail the risk of a dust explosion in the presence of air. Conditions to avoid : No data available. Substances to avoid : No data available. Hazardous decomposition products 11. Toxicological Information : No data available. Acute oral toxicity : Approx. LD50 > mg/kg Acute inhalation toxicity : No data available. Acute dermal toxicity : No data available. Repeated dose toxicity : NOAEL: = 100 mg/kg Exposition time: 28-day The values mentioned are those of the active ingredient. NOAEL: = 100 mg/kg Exposition time: 90-day The values mentioned are those of the active ingredient. NOAEL: = 100 mg/kg Exposition time: 26 weeks The values mentioned are those of Exposition time: 28-day The values mentioned are those of the active ingredient. Page 4 from 6

5 Exposition time: 13 weeks The values mentioned are those of Exposition time: 26 weeks The values mentioned are those of Exposition time: 52 weeks The values mentioned are those of Skin irritation : Non-irritant (rabbit) Method: Acute Dermal Irritation/Corrosion. Eye irritation : No eye irritation (rabbit) Method: OECD Guideline 405 Sensitization : Non-sensitizing. (mouse) Method: OECD 429 Genetic toxicity in vitro : Ames-test Salmonella typhimurium Result: negative Mouse lymphoma assay mouse lymphoma cells Result: negative Genetic toxicity in vivo : Micronucleus assay Result: negative Carcinogenicity : No data available. Reproductive toxicity : Study of Fertility and Early Embryonic Development NOAEL Parents: 300 mg/kg Teogenicity : No data available. Aspiion hazard : No data available. Study of Fertility and Early Embryonic Development NOAEL Parents: 100 mg/kg NOAEL F1-Geneion: 300 mg/kg 12. Ecological information Ecotoxicity Page 5 from 6

6 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 invertebes : No data available. Persistence and degradability Biological degradation : No data available. Bioaccumulation : No data available. PBT and vpvb assessment : 13. Disposal Consideions 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 2 water endangering Annex 4 VwVwS (Germany) dated Mai, 17 th Other particulars Prepared by: Environmental Health & Safety Date Prepared: June 13, 2014 Replaces: N/A The information provided in this is correct to the best of our knowledge, information and belief at the date of its publication. The information given is designed only as 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