Isotretinoin Relevant identified uses of the substance or mixture and uses advised against

Transcription

1 Safety Data Sheet Isotretinoin according to Regulation (EU) nr. 1907/2006 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product name Isotretinoin Product code Relevant identified uses of the substance or mixture and uses advised against Use pharmaceutical active substance pharmaceutical active substance in ROACCUTAN /ACCUTANE preparations oral treatment of severe acne, resistant against other therapies 1.3. Details of the supplier of the safety data sheet Company information Enquiries: F. HoffmannLa Roche AG Postfach CH4070 Basel Switzerland Local representation: Phone +4161/ Fax +4161/ info.sds@roche.com 1.4. Emergency telephone number Emergency telephone number Phone +4161/ Page: 1/8

2 SECTION 2: Hazards identification 2.1. / 2.2. Classification of the substance or mixture / Label elements GHS Classification Health Hazards: 3.2 Skin corrosion/irritation (Category 2) H315 Causes skin irritation. 3.3 Serious eye damage/eye irritation (Category 2A) H319 Causes serious eye irritation. 3.7 Reproductive toxicity (Category 1A) H360D May damage the unborn child. 3.8 Specific target organ toxicity Single exposure (Category 3) H335 May cause respiratory irritation. Environmental Hazards: 4.1 Hazardous to the aquatic environment (Category 1) H400 Very toxic to aquatic life. 4.1 Hazardous to the aquatic environment (Category 1) H410 Very toxic to aquatic life with long lasting effects. Signalword: Danger Label: Precautionary statements: P201 Obtain special instructions before use. P273 Avoid release to the environment. P280 Wear protective gloves/ protective clothing / eye protection / face protection. P302 + P352 IF ON SKIN: Wash with plenty of water/& P309 + P310 IF exposed or if you feel unwell: Immediately call a POISON CENTER or doctor/physician. P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing Other hazards women of childbearing potential have to avoid any overexposure (limit values see chapter 8) may form explosible dustair mixture if dispersed SECTION 3: Composition/information on ingredients Characterization Chemical name Synonyms pharmaceutical active substance in the class of retinoides 3,7Dimethyl9(2,6,6trimethyl1cyclohexene1yl) 2cis4,6,8nonatetraenic acid Isotretinoin (INN) 13cisRetinoic acid 13cisVitamin A acid Roaccutane Page: 2/8

3 CAS number EINECS number UN number 3077 Roche number Molecular mass RO g/mol O OH SECTION 4: First aid measures 4.1. Description of first aid measures Eye contact Skin contact Inhalation rinse immediately with tap water for at least 20 minutes open eyelids forcibly consult a physician remove immediately contaminated clothes, wash affected skin with water and soap do not use any solvents remove the casualty to fresh air and keep him/her calm get medical treatment 4.2. Most important symptoms and effects, both acute and delayed 4.3. Indication of any immediate medical attention and special treatment needed to physician treat symptomatically in case of suspected ingestion consider analysis of biological material (protect blood samples from light) SECTION 5: Firefighting measures 5.1. Extinguishing media Suitable extinguishing media water spray jet, dry powder, foam, carbon dioxide 5.2. Special hazards arising from the substance or mixture Specific hazards very high probability of ignition of dust whirled up substance is hazardous for water: contain firefighting wastewater Page: 3/8

4 5.3. Advice for firefighters Protection of firefighters Special method of firefighting precipitate gases/vapours/mists with water spray for reasons of environmental protection hold the extinguishing agent back SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures Personal precautions prevent any exposure 6.2. Environmental precautions Environmental protection do not allow to enter drains or waterways if the substance reaches waters or the sewer system, inform the competent authority 6.3. Methods and material for containment and cleaning up Methods for cleaning up collect solids (avoid dust formation) and hand over to waste removal clean contaminated areas with little ethanol SECTION 7: Handling and storage 7.1. Precautions for safe handling Technical measures Suitable materials processing in closed systems, superposed by inert gas (exception possible for dry product < 50kg) local exhaust ventilation necessary take precautionary measures against electrostatic charging avoid dust formation; very high dust explosion hazard connect conductive pieces of equipment, products and packaging to earth handling under inert conditions stainless steel 7.2. Conditions for safe storage, including any incompatibilities Storage conditions Validity protected from light under argon < 8 C for quality reasons protected from humidity 24 months, 2 to 8 C, under argon Page: 4/8

5 SECTION 8: Exposure controls/personal protection 8.1. Control parameters Threshold value (Roche) air IOEL (Internal Occupational Exposure Limit): mg/m Exposure controls General protective and hygiene measures Respiratory protection Hand protection Eye protection Body protection Analytics instruction of employees mandatory shower after work recommended in case of open handling or accidental release: particle mask or respirator with independent air supply protective gloves (eg made of neoprene, nitrile or butyl rubber) safety glasses protective clothing connect persons to earth by means of conductive shoes and conductive floor sampling on glassfiber filter and chemical determination of the active compound (eg HPLC) SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties Colour Form Odour Solubility Partition coefficient yelloworange fine, crystalline powder characteristic < 100 mg/l, water (25 C) mg/l, peanut oil (25 C) mg/l, ethanol (25 C) mg/l, noctanol (25 C) mg/l, acetone (25 C) log P ow 6.6 (octanol/water C) Melting temperature 176 C 9.2. Other information Page: 5/8

6 SECTION 10: Stability and reactivity Reactivity Chemical stability Possibility of hazardous reactions Conditions to avoid Conditions to avoid light (gradual decomposition) warming (gradual decomposition) Incompatible materials Materials to avoid atmospheric oxygen, oxidizing agents Hazardous decomposition products SECTION 11: Toxicological information Information on toxicological effects Acute toxicity LD mg/kg (oral, mouse) LD 50 > mg/kg (oral, rat) Subacute toxicity LD mg/kg/d (oral, mouse, 11 days) LD mg/kg/d (oral, rat, 11 days) Local effects Sensitization skin: strongly irritant (guinea pig); 1 % solution in acetone mucous membranes: irritant skin: irritant Mutagenicity Carcinogenicity not mutagenic (various test systems) not cancerogenic Reproductive toxicity STOTsingle exposure teratogenic (human and animal) Page: 6/8

7 STOTrepeated exposure Aspiration hazard dosage: daily mg/kg (oral) halflife of elimination: between 7 39 hours (average approx. 20 hours) systemic symptoms: signs of vitamin A hypervitaminosis (dryness of mucous membranes, exanthems, pruritus; high doses: signs of intracranial pressure like headache, vomiting, etc.) SECTION 12: Ecological information Toxicity Ecotoxicity strongly toxic for planktonic crustaceans (Daphnia magna) EC 50 (48 h) 2.06 mg/l (FDA Technical Assistance Document No. 4.08) highly toxic for fish (rainbow trout) LC 100 (96 h) 0.61 mg/l LC 50 (96 h) 0.52 mg/l LC 0 (96 h) 0.45 mg/l NOEC (96 h) 0.05 mg/l (OECD No. 203) barely toxic for microorganisms (activated sludge) LC 50 (3 h) > 100 mg/l (Activated Sludge Respir. Inhib. Test, OECD No. 209) Persistence and degradability Inherent biodegradability inherently biodegradable 59 %, 28 days (MITI Test II, OECD No. 302 C) Bioaccumulative potential Mobility in soil Results of PBT and vpvb assessment Other adverse effects Air pollution observe local/national regulations the substance shows a potential of bioaccumulation Page: 7/8

8 SECTION 13: Disposal considerations Waste treatment methods Waste from residues Contaminated packaging incinerate in qualified installation with flue gas scrubbing observe local/national regulations regarding waste disposal incinerate contaminated packaging material in qualified installation with flue gas scrubbing SECTION 14: Transport information IATA Class UN/ID PG PI Label III 956/956 9 Mark EHS IMDG Class UN PG EmS PI Label Mark III FA SF P002/IBC08 9 marine pollutant RID/ADR Class UN PG Haz.no PI Label Mark Classif. code III 90 P002/IBC08 9 EHS M7 Proper shipping name ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S. Technical name Isotretinoin SECTION 15: Regulatory information Safety, health and environmental regulations/legislation specific for the substance or mixture Water hazard class (Germany) 3: strongly hazardous for water (own classification according to directive VwVwS of ) SECTION 16: Other information Safetylab number BS2435 BS7164 BS9093 Edition documentation changes from previous version in sections 2 The information in this safety data sheet is based on current scientific knowledge. It should not be taken as expressing or implying any warranty concerning product characteristics. Page: 8/8