Fluorouracil Relevant identified uses of the substance or mixture and uses advised against. - pharmaceutical active substance (cytostatic)

Transcription

1 Safety Data Sheet 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 Product code Relevant identified uses of the substance or mixture and uses advised against Use pharmaceutical active substance (cytostatic) 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: 1/9

2 SECTION 2: Hazards identification 2.1. / 2.2. Classification of the substance or mixture / Label elements GHS Classification Health Hazards: 3.1 Acute toxicity (Category 3) H301 Toxic if swallowed. 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. 3.5 Germ cell mutagenicity (Category 1B) H340 May cause genetic defects. 3.6 Carcinogenicity (Category 1B) H350 May cause cancer. 3.7 Reproductive toxicity (Category 1A) H360D May damage the unborn child. 3.7 Reproductive toxicity (Category 1B) H360F May damage fertility. Environmental Hazards: 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. P281 Use personal protective equipment as required. P301 + P310 IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician. P308 + P313 IF exposed or concerned: Get medical advice/attention Other hazards Cytostatics in general have to be classified as potentially carcinogenic, teratogenic and mutagenic. During handling any occupational exposure as well as environmental contamination have to be avoided. may form explosible dustair mixture if dispersed SECTION 3: Composition/information on ingredients Characterization Chemical name pharmaceutical active substance in the class of cytostatics 5Fluoro2,4(1H,3H)pyrimidindione Page: 2/9

3 Synonyms Flurazil 5Fluorouracil 5FU CAS number EINECS number UN number 2811 Roche number Ro /000 Empirical formula C 4 H 3 FN 2 O 2 Molecular mass g/mol O HN F O N H 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 consult physician 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 control of haemogram every 23 days for 23 weeks SECTION 5: Firefighting measures 5.1. Extinguishing media Suitable extinguishing media water spray jet, dry powder, foam, carbon dioxide Page: 3/9

4 5.2. Special hazards arising from the substance or mixture Specific hazards formation of toxic and corrosive combustion gases (hydrogen fluoride, nitrogen oxides) possible consider dust explosion hazard substance is hazardous for water: contain firefighting wastewater 5.3. Advice for firefighters Protection of firefighters precipitate gases/vapours/mists with water spray chemical incident emergency response unit with full protective equipment 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 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 SECTION 7: Handling and storage 7.1. Precautions for safe handling Technical measures Suitable materials processing in closed systems, if possible superposed by inert gas (e.g. nitrogen) local exhaust ventilation necessary take precautionary measures against electrostatic charging avoid dust formation stainless steel, steel, aluminium, glass, plastic 7.2. Conditions for safe storage, including any incompatibilities Validity 36 months, 2 to 15 C 60 months, 2 to 8 C *1 *1 referring to: micropowder Page: 4/9

5 SECTION 8: Exposure controls/personal protection 8.1. Control parameters Threshold value (Roche) air IOEL (Internal Occupational Exposure Limit): mg/m3 any occupational exposure as well as environmental contamination have to be avoided 8.2. Exposure controls General protective and hygiene measures Respiratory protection Hand protection Eye protection Body protection Analytics instruction of employees mandatory 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 sampling on glass fibre filter and gravimetric or chemical determination SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties Colour Form Odour Solubility Partition coefficient Melting temperature Boiling temperature white to practically white crystalline powder almost odourless mg/l, water (20 C) mg/l, ethanol absolute (20 C) < 100 mg/l, diethyl ether (20 C) < 100 mg/l, toluene (20 C) log P ow 0.69 (noctanol/water) (citation from literature) 280 to 284 C (with decomposition) 190 to 200 C (0.13 hpa) 9.2. Other information Page: 5/9

6 SECTION 10: Stability and reactivity Reactivity Chemical stability Possibility of hazardous reactions Conditions to avoid Conditions to avoid temperatures above 200 C Incompatible materials Materials to avoid bases Hazardous decomposition products stable in normal conditions SECTION 11: Toxicological information Information on toxicological effects Acute toxicity LD mg/kg (oral, mouse) LD mg/kg (oral, rat) LD mg/kg (oral, rabbit) LD mg/kg (oral, dog) Local effects Sensitization skin: irritant eye: irritant Mutagenicity Carcinogenicity mutagenic (various test systems) no information available Reproductive toxicity STOTsingle exposure teratogenic (several species) embryotoxic (several species) suspected to be teratogenic and to lower parental fertility *2 Page: 6/9

7 STOTrepeated exposure Aspiration hazard dosage:daily dose 15 mg/kg oral (maintenance dose) or 600 mg/m² (1 time/week) cytostatics are potentially carcinogenic sideeffects: nausea, vomiting, diarrhea, gastro intestinal bleeding, nose bleeding halflife of elimination: 11 minutes metabolisation / elimination practically exclusively by the liver *2 referring to: Capecitabine SECTION 12: Ecological information Toxicity Ecotoxicity highly toxic for algae (Selenastrum capricornutum) EC 50 (72 h) 0.11 mg/l NOEC (72 h) 0.01 mg/l (ISO test 8692) moderately toxic for planktonic crustaceans (Daphnia magna) EC 50 (48 h) 25 mg/l EC 10 (48 h) 1.3 mg/l (EEC, L 383 A, C.2) barely toxic for fish (rainbow trout) NOEC (48 h) 1000 mg/l LC 50 (48 h) > 1000 mg/l (OECD No. 203) no adverse influence on substrate biodegradation (activated sludge) concentration (28 d) 854 mg/l (ZahnWellens test, OECD 302 B) Persistence and degradability Ready biodegradability Inherent biodegradability not readily biodegradable 0 %, 28 d 0 %, 40 d (Closed Bottle Test, OECD No. 301 D) evidence for shortterm biodegradation in surface waters 2 d halflife (OECD 308, Transformation in natural water/sediment systems) not inherently biodegradable 2 %, 28 d (ZahnWellens test, OECD No. 302 B) biodegradable in sewage works 25 %, 1 d 65 %, 4 d 81 %, 7 d 97 %, 14 d (Simulation Aerobic Sewage Treatment, OECD No. 303 A) Page: 7/9

8 12.3. Bioaccumulative potential Mobility in soil Results of PBT and vpvb assessment Other adverse effects Air pollution observe local/national regulations SECTION 13: Disposal considerations Waste treatment methods Waste from residues incinerate in qualified installation with flue gas scrubbing observe local/national regulations regarding waste disposal SECTION 14: Transport information IATA Class UN/ID PG PI Label III 670/ Mark EHS IMDG Class UN PG EmS PI Label Mark III FA SA P002/IBC marine pollutant RID/ADR Class UN PG Haz.no PI Label Mark Classif. code III 60 P002/IBC EHS T2 Proper shipping name TOXIC SOLID, ORGANIC, N.O.S. Technical name 5 Page: 8/9

9 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 BS2261 Edition documentation changes from previous version in sections 2, 6 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: 9/9