0420190.20020712.5410.pdf

Dec 15, 2016 | Publisher: Global Documents | Category: News & Politics |  

Ethoxyfluorouracil Safety Data Sheet 1. Product and Company Identification Product name Ethoxyfluorouracil Product code 04 2019 0 Manufacturer: F. Hoffmann-La Roche AG Postfach CH-4070 Basel Switzerland Phone *41-61/688 54 80 Fax *41-61/681 72 76 Local representation: Company information 2. Composition/Information on ingredients Chemical name - 2-Ethoxy-5-fluoro-4(1H)-pyrimidinone CAS number 56177-80-1 EINECS number 260 029 1 Roche number Ro 07-5597/000 Empirical formula C6H7FN2O2 Molecular mass 158.13 g/mol N N H O O F 3. Hazards identification Most important hazards - May cause cancer. - May cause heritable genetic damage. - May cause harm to the unborn child. Note - 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. Page: 1/5 Replacing edition of: 26.3.98 Date: 12.7.02/CSE (SEISMO) Ethoxyfluorouracil 4. First-aid measures Eye contact - rinse immediately with tap water for 10 minutes - open eyelids forcibly - consult physician Skin contact - remove immediately contaminated clothes, wash affected skin with water and soap - do not use any solvents Inhalation - remove the casualty to fresh air - consult physician Note to physician - treat symptomatically - after massive exposition control of hemogram every 2 - 3 days for 2 - 3 weeks 5. Fire-fighting measures Suitable extinguishing media - water spray jet, dry powder, foam, carbon dioxide Specific hazards - formation of toxic and corrosive combustion gases (hydrogen fluoride, nitrogen oxides) possible Protection of fire-fighters - precipitate gases/vapours/mists with water spray - use self-contained breathing apparatus Special method of fire-fighting - cool endangered containers with water spray 6. Accidental release measures Personal precautions - keep people away and stay on the upwind side Environmental protection - avoid release to the environment Methods for cleaning up - collect solids (avoid dust formation) and hand over to waste removal 7. Handling and storage Handling Technical measures - processing in closed systems, superposed by inert gas (e.g. nitrogen) - avoid dust formation; consider dust explosion hazard - local exhaust ventilation necessary - take precautionary measures against electrostatic charging Suitable materials - stainless steel, glass, enamel, polyethylene Storage Validity - 36 months, at room temperature Packaging materials - tightly closing; material: glass, enamel, polyethylene, coated steel (lined with polyethylene bag) Page: 2/5 Replacing edition of: 26.3.98 Date: 12.7.02/CSE (SEISMO) Ethoxyfluorouracil 8. Exposure controls/Personal protection Engineering Measures - see 7. Personal protective equipment Respiratory protection - in case of open handling or accidental release: particle mask or respirator with independent air supply Hand protection - protective gloves (natural latex) Eye protection - safety glasses Body protection - protective clothing General protective and hygiene measures - instruction of employees mandatory 9. Physical and chemical properties Colour light beige Form crystalline powder partly with lumps Odour none to faint Bulk density ~ 0.4 g/cm3 Melting temperature 175 to 182 C Flash point (liquid) 102 C (DIN 51'758) Ignition point (liquid) 530 C Note - The measurements of both flash and ignition point were performed in the (undercooled) melt ! 10. Stability and reactivity Stability - stable under normal conditions Conditions to avoid - humidity Materials to avoid - strong bases 11. Toxicological information Acute toxicity LD50 > 2'400 mg/kg (oral, rat) - LD50 550 mg/kg (oral, mouse) - Note - When in contact with water, Ethoxyfluorouracil slowly reacts to 5-Fluorouracil. 5-Fluorouracil is an experimental teratogen, embryotoxicant and mutageni.Based on mechanistic considerations, it must be assumed, that 5-Fluorouracil is also carcinogenic. Page: 3/5 Replacing edition of: 26.3.98 Date: 12.7.02/CSE (SEISMO) Ethoxyfluorouracil 12. Ecological information Ready biodegradability - not readily biodegradable < 10 %, 28 days (CO2 Evolution Test (Modified Sturm Test), OECD No. 301 B) Ecotoxicity barely toxic for planktonic crustaceans (nominal concentration > 100 mg/l) (Daphnia magna) EC50 (48 h) > 100 mg/l NOEC (48 h) 87.5 mg/l (OECD No. 202) - moderately toxic for algae (Selenastrum capricornutum) EbC50 (72 h) 90 mg/l ErC50 (72 h) 122 mg/l NOEC (72 h) 56 mg/l (OECD No. 201) - strongly toxic for microorganisms - Air pollution - observe local/national regulations 13. Disposal considerations Waste from residues - observe local/national regulations regarding waste disposal - incinerate in qualified installation with flue gas scrubbing 14. Transport information Note - not classified by transport regulations 15. Regulatory information EU classification and labelling R45 May cause cancer. R46 May cause heritable genetic damage. R61 May cause harm to the unborn child. S36/37/39 Wear suitable protective clothing, gloves and eye/face protection. S45 In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible). S53 Avoid exposure --- obtain special instructions before use. T Emission limit (Switzerland) 5 mg/m3 at mass-flux 25 g/h (carcinogenic, class 3; own classification) Water hazard class (Germany) 3: strongly hazardous for water (own classification according to directive VwVwS of 17.05.1999) Page: 4/5 Replacing edition of: 26.3.98 Date: 12.7.02/CSE (SEISMO) Ethoxyfluorouracil 16. Other information Use - intermediate Safety-lab number - BS-1225 Edition documentation - changes from previous version in sections 7, 15 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: 5/5 Replacing edition of: 26.3.98 Date: 12.7.02/CSE (SEISMO)

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