Safety Data Sheet for Drug product

Transcription

1 1. Identification of the substancepreparation and of the company Product name VOLTAREN GEL 1%(NA) 001 Chemical Class phenylacetic acid derivative Generic Name Diclofenac sodium Pharmacological Action Analgesic, antiphlogistic, antirheumatic, antiphlogistic, Inhibitor of prostaglandin biosynthesis Usage Drug product (pharmaceutical bulk, primary packed, finished product, pharmaceutical intermediate) 2. Hazards identification For side effects, which could also have impact for people working with this substance, please refer to the Patient Information Leaflet. 3. Composition information on ingredients For classification of declared components, see section 15, "Regulatory Information" Chemical Name Contains: CAS Number ISOPROPANOL approx. 20 % Diclofenac sodium 1 % Remaining components are inert ingredients. For TLV values of declared components, see Section 8, Exposure controls Personal 4. First aid measures Eye Contact Skin Contact Inhalation Ingestion Notes to Physician Immediately rinse eyes thoroughly with running water as long as possible (approx. 15 min). Take injured quickly to factory medical center or call an ambulance (code word: eye accident). Remove contaminated clothing. Rinse contaminated skin immediately with plenty of water and soap and seek medical advice. Remove the victim from danger zone, avoid further exposure. If swallowed, seek medical advice immediately and show this container or label. General measures to eliminate the substance and to reduce absorption. 5. Fire fighting measures Suitable Extinguishing Media Unsuitable Extinguishing Media Dangerous Combustion Products Protective equipment for firefighters Water spray or fog, foam, dry chemical powder, CO2, dry sand No restrictions 6. Accidental release measures nitrogen oxides, hydrogen chloride, carbon oxides Wear self-contained breathing apparatus and fire protective suite. Personal precautions Environmental precautions Methods for cleaning Avoid contact with skin, eyes and clothing. Must not be released into sewers, drains or wells. Transfer large quantities into a container. Clean up the rest with absorbent material and discharge properly. 7. Handling and storage Issued by Pharma Global HSE&BC, printed by KSO System Page: 1 6

2 No special handling requirements for normal use of this material. Store in a dry and cool place and observe special instructions from supplier. 8. Exposure controls Personal protection Occupational Exposure Limit (OEL) no data available TLV values of declared components Contains: ISOPROPANOL List type Value Unit STEL-Spain (Short Term Exposure Limit) 1000 mgm3 400 WEL-United Kingdom (15 minute TWA) 1250 mgm3 500 STEL Switzerland (Short term exposure limit) mgm3 STEL-Ireland (Short Term Exposure Limit) 400 Poisoning by cutaneous absorption possible. STEL (ACGIH USA) Short term exposure limit 400 Not classifiable as a human carcinogen. TLV-Values Austria 500 mgm3 200 OEL-Spain (TLV) 500 mgm3 200 TLV-SUVA Switzerland mgm3 Does not cause harm to the unborn child, if air TLVs are TLV- Germany (TRGS 900, Limit Values in the Ambient Air at the Workplace) mgm3 respected. Does not cause harm to the unborn child, if air TLVs are respected. OEL-Ireland (TLV) 200 Poisoning by cutaneous absorption possible. TLV-ACGIH USA 200 Not classifiable as a human carcinogen. WEL-United Kingdom (8 hour TWA) Odour threshold Contains: Diclofenac sodium List type mgm3 µgm3 Value Unit Internal exposure limit 160 µgm3 HHA Database Personal protection for open handling Health care personnel Safety glasses (EN166) Lab coat Disposable gloves (EN374) 9. Physical and chemical properties Formulation gel Flash Point 18.5 C Method: DIN Test result of the preparation. Issued by Pharma Global HSE&BC, printed by KSO System Page: 2 6

3 10. Stability and reactivity Under the normal conditions of use, the product is stable. 11. Toxicological information Acute Toxicity Irritation, Corrosion Sensitisation Mutagenicity Chronic Effects Reproduction Toxicity LD50: 62.5 mgkg Species: rat Free acid LD50: mgkg Species: rat LD50: 117 mgkg Route: intravenous Species: rat no data available no data available Negative with and without metabolic activation (Mouse Lymphoma Mutagenicity Assay in vitro) in vitrocell: Lymphoma cells L5178Y of the mouse Negative with and without metabolic activation (AMES-Test (reverse mutation assay)) in vitrocell: Strains of salmonella typhimurium. Negative (Chromosome Aberration Study) in vivo, Species: rat Slight toxicity (Repeated Dose Toxicity) NOAEL: 1 mgkgd Species: rat, Organ: Gastrointestinal tract Dosage: <= 4 mgkgd, Duration: 6 months Severe toxicity (Repeated Dose Toxicity) LOAEL: 5 mgkgd Species: Baboon, Organ: Gastrointestinal tract Dosage: <= 50 mgkgd, Duration: 12 months No evidence for carcinogenicity (Carcinogenesis) NOAEL: 0.3 mgkgd Species: mouse, Organ: Gastrointestinal tract Dosage: <= 2 mgkgd, Duration: 104 weeks No evidence for carcinogenicity (Carcinogenesis) NOAEL: 0.5 mgkgd Species: rat, Organ: Gastrointestinal tract Dosage: <= 2 mgkgd, Duration: 104 years No Teratogenicity (Embryo-Fetal Development) Issued by Pharma Global HSE&BC, printed by KSO System Page: 3 6

4 12. Ecological information NOAEL: 4 mgkgd Species: rat, Sex: female Embryotoxicity - no teratogenicity (Embryo-Fetal Development) NOAEL: 5 mgkgd Species: rabbit, Sex: female Increase in stillbirths gestation time prolonged (Segment III (Peri- and postnatal toxicity)) LOAEL: 2 mgkgd Species: rat, Sex: female Negative (Fertility and general reproductive performance study) LOAEL: 2 mgkgd Species: rat, Sex: both sexes Biological Elimination Fish acute toxicity Fish chronic toxicity Aquatic invertebrate acute toxicity Degradation: 55.5 % (aerobic: Temperature: C BOD) Not readily degradable Initial conc.: 3.3 mgl, Duration: 28 days, Half life: days Method: OECD 301D * 1981 Degradation: 14 % (aerobic: Temperature: C DOC) Not readily degradable Initial conc.: 20 mg DOCl, Duration: 28 days Method: OECD 301E * 1981 LC50: 214 mgl Species: zebra fish (danio rerio) Exp. time: 96 hours Method: OECD 203 * 1984 * acute toxicity LOEC: 8 mgl NOEC: 4 mgl Species: zebra fish (danio rerio) Exp. time: 10 days Method: ISO (1999) LOEC: 1 mgl NOEC: NOEC: 0.32 mgl Species: rainbow trout (salmo gairdneri, oncorhynchus mykiss) Exp. time: 95 days Method: OECD 210 * 1992 LOEC: 1 mgl NOEC: NOEC: 0.32 mgl Species: zebra fish (danio rerio) Exp. time: 34 days Method: OECD 210 * 1992 EC50: 56 mgl Species: daphnia magna (water flea) Exp. time: 24 hours Issued by Pharma Global HSE&BC, printed by KSO System Page: 4 6

5 Aquatic invertebrate chronic toxicity Algae Toxicity Bacterial Respiration Inhibition Ecotoxicity Summary Method: OECD 202 * 2004 EC50: 22.7 mgl Species: Ceriodaphnia dubia Exp. time: 48 hours Method: AFNOR T (1974) LOEC: 2 mgl NOEC: 1 mgl Species: Ceriodaphnia dubia Exp. time: 7 days Method: AFNOR T (2000) LOEC: 20 mgl NOEC: 10 mgl Species: Green algae - fresh water (Pseudokirchneriella subcapitata) Exp. time: 96 hours EC50: 72 mgl Species: Desmodesmus subspicatusscenedesmus subspicatus (Green algae) Exp. time: 3 days Method: 9269EC (L383) C.3 EC50: 7.5 mgl Species: Lemna minor (Common Duckweed) Exp. time: 7 days Method: ISO * 2001 EC50: > 100 mgl Species: activated sludge Exp. time: 3 hours Method: OECD 209 * 1984 Avoid release into soil, rivers or drains. 13. Disposal considerations Disposal Requirements Fill into suitable waste receptacles, seal and label them properly. Incineration in an approved, controlled furnace with combustion gas scrubbing and emission gas control. Local regulations should be adhered to. 14. Transport information Regulation Class UN No. PG Label LQ RIDADR: Not restricted 0 N.A. IMDG-Code: III 3 5 L ICAOIATA-DGR: III 3 ICAOIATA-DGR: Proper shipping name: classified Alcohols, n.o.s. ( Isopropanol mixture) 15. Regulatory information Classifications of components: Chemical Name Contains: CAS Number Picto Signal Word Classification Issued by Pharma Global HSE&BC, printed by KSO System Page: 5 6

6 ISOPROPANOL approx. 20 % D H319, H336, H225 Diclofenac sodium 1 % D H302, H361d, H372, H401, H411 Remaining components are inert ingredients. 16. Other information Changes since the 14. Transport information previous version in Section Abbreviations used H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. H302: Harmful if swallowed. H361d: Suspected of damaging the unborn child. H372: Causes damage to organs through prolonged or repeated exposure. H401: Toxic to aquatic life.(in EU not leading to classification as hazardous) H411: Toxic to aquatic life with long lasting effects. Recipient Patrick Gailliot Sandoz Inc. External Supply Organization Non-Sterile Products North America 100 college road west Princeton NJ USA Product should be stored, handled and used in accordance with good industrial hygiene practices and in conformity with legal regulations. The information contained herein is based on the present state of our knowledge and is intended to describe our products from the point of view of safety requirements. It should therefore not be construed as guaranteeing specific properties. Issued by Pharma Global HSE&BC, printed by KSO System Page: 6 6