MSDS-Fluorouracil[1]

FLUOROURACIL REVISION 03 21/02/2007 1/3

SAFETY DATA SHEET according to ISO 11014-1, Directives 67/548/EC and 2001/58/EC.

1. IDENTIFICATION OF THE SUBSTANCE / PREPARATION AND OF THE COMPANY/UNDERTAKING FLUOROURACIL CRS European Directorate for the Quality of Medicines & HealthCare

European Pharmacopoeia (Ph. Eur.) 7, Allée Kastner CS 30026, F-67081 Strasbourg (France)

Tel. +33 (0)3 88 41 20 35 Fax. + 33 (0)3 88 41 27 71 For any question: www.edqm.eu (HelpDesk)

Catalogue code: F0250000

2. COMPOSITION/INFORMATION ON INGREDIENTS C4H3FN2O2 Mr 130.1 CAS: 51-21-8 EC No: 200-085-6 NB: Antimetabolite. Cytotoxic. Symbols: T, N R phrases: R22, R36/37/38, R45, R46, R60, R61, R50/53

3. HAZARDS IDENTIFICATION Substance is not classified in Annex I of Directive 67/548/EC. Harmful if swallowed. Irritating to eyes, respiratory system and skin. May cause cancer. May cause heritable genetic damage. May impair fertility. May cause harm to the unborn child. Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. Interferes with DNA synthesis. Lowers white blood cell count exposing to infections up to three weeks from the exposure. May cause severe cardiovascular effects and gastrointestinal disturbances. May cause an allergic reaction.

4. FIRST AID MEASURES Inhalation: Remove to fresh air. If breathing becomes difficult, call a physician. Skin contact: Flush with copious amounts of water and soap for at least 15 minutes. Remove contaminated clothing

and shoes. Hydrocortisone cream 1% may be used to treat the transient stinging of the skin. Eyes contact: Assure adequate flushing by separating the eyelids with fingers. Flush with copious amounts of water or

normal saline for at least 15 minutes. Seek medical advice. Ingestion: Wash out mouth with water and administer fresh water provided that the person is conscious. Seek

medical advice. In case of reactions described in hazards identification or other severe, immediate or persisting symptoms seek medical advice and call the nearest poison centre. Show the label and this safety data sheet.

5. FIRE FIGHTING MEASURES Extinguishing media: Water spray. Carbon dioxide, dry chemical powder or appropriate foam. Precipitate gases or fumes with

water spray to limit exposure. Contain waste water to avoid environmental pollution. Dust may form explosive mixture in air. Wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes. Emits toxic fumes under fire conditions. Dangerous combustion products: COx, NOx, HF and other noxious gases or vapours in case of incomplete combustion.

6. ACCIDENTAL RELEASE MEASURES Safety shower and eye bath. Wear self-contained breathing apparatus, rubber boots and heavy rubber gloves. Switch off electrical equipment and any other sources of ignition. Collect residues manually, place in a bag and hold for waste disposal. Avoid raising dust. Ventilate area and remove remaining residues by wiping spill site with 5% sodium hypochlorite solution after material pick up is complete. Contaminated material should be placed in a thick plastic bag or other impervious container, marked and treated as cytotoxic waste. Wash spill site with 5% sodium hypochlorite solution and, if possible, leave to deactivate for 24 hours. Repeat washing of the spill site with water/detergent solution and rinse with water.


7. HANDLING AND STORAGE Handling: Handle in closed systems superposed by inert gas. Avoid inhalation. Avoid contact with eyes, skin and

clothing. Avoid prolonged or repeated exposure. Storage: Keep unopened in the original container at about 2-8 °C. Keep tightly closed. Protect from heat and

light. Protect from moisture. Suitable materials: Stainless steel, steel, aluminium, glass, plastic. Chemical deactivation: 5% Sodium Hypochlorite over 24 hours.

8. EXPOSURE CONTROLS/PERSONAL PROTECTION OEL (supplier data): 0.005 mg/m3 Respiratory protection: Protecting mask (filter P3). Hand protection: Compatible chemical-resistant gloves. Eye protection: Wear protective chemical safety goggles.

9. PHYSICAL AND CHEMICALS PROPERTIES Appearance: White or almost white, crystalline powder. Solubility: Sparingly soluble in water, slightly soluble in ethanol (96 per cent).

10. STABILITY AND REACTIVITY Stability: Stable. Conditions to avoid: Light. Heat. Ignition. Materials to avoid: Strong oxidizing agents. Strong bases. Dangerous decomposition products: COx, NOx, HF and other substances in case of incomplete decomposition. Hazardous polymerisation will not occur.

11. TOXICOLOGICAL INFORMATION RTECS No: YR0350000 LD50 (oral-rat): 230 mg/kg LD50 (oral-mouse) 115 mg/kg LD50 (oral-rabbit) 19 mg/kg LD50 (oral-dog) 30 mg/kg Causes photosensibility. Exposure to light can result in allergic reactions. Eye, skin and respiratory system irritant. Fluorouracil has been shown to be carcinogenic, mutagenic and embryotoxic in different experiments. IARC classification: Group 3. See actual entry in RTECS for complete information.

12. ECOLOGICAL INFORMATION Biodegradability (ready, 40d) 0%. Not readily biodegradable. Biodegradability (inherent, 28d) 2%. Not inherently biodegradable. Biodegradability (sewage, 1d) >25% Biodegradability (sewage, 14d) >97% EC50 (Selenastrum capricornutum, 72h) 0.11 mg/L. Highly toxic. EC50 (Daphnia magna, 48h) 25 mg/L. Moderately toxic. LC50 (Rainbow trout, 45h) 1000 mg/L. Barely toxic. Log Pow -0.69. Lipophilic. Bioaccumulation risk is high.

13. DISPOSAL CONSIDERATIONS Incinerate at a minimum of 700 °C in an approved facility. Observe all federal state and local environmental regulations.

14. TRANSPORT INFORMATION UN number 3077 – Class 9 – PG III


15. REGULATORY INFORMATION

Symbols: T, N R22, R36/37/38, R45, R46, R60, R61, R50/53, S22, S28, S45, S36/37/39, S53, S57, S59, S60, S61 CMR: Carc. Cat 1, Mut. Cat 1, Rep. Cat. 2.

16. OTHER INFORMATION Reason for update: Revision according to Directives 2001/58/EC. New name and address of the EDQM. R22 Harmful if swallowed. R36/37/38 Irritating to eyes, respiratory system and skin. R45 May cause cancer. R46 May cause heritable genetic damage. R60 May impair fertility R61 May cause harm to the unborn child. R34 Causes burns. R50/53 Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

Warning! Reference Substance / Preparation - important notice. The chemical substance or biological preparation to which this Safety Data Sheet relates is supplied exclusively as a reference substance/preparation for chemical or biological test and assay purposes and on the basis of the Terms of Supply and notes on Use of Reference Standards set out in the Official catalogue of the European Pharmacopoeia CRS, IR spectra, BRP. It is to be used for no other purpose and is not for human or animal consumption. The information set out in this sheet is applicable solely to the substance/preparation when used as a European Pharmacopoeia Chemical Reference Substance (Ph. Eur. CRS) or Biological Reference Preparation (Ph. Eur. BRP) and is not intended to apply to any other use or preparation of the substance (e.g. at different concentrations, in drug dosage form or in bulk quantities). The information which follows has been assembled by Ph. Eur. staff from sources considered reliable, in particular from material provided in the ordinary way by the manufacturer or supplier. It has not been independently verified by the Ph. Eur. The accuracy of the information cannot therefore be guaranteed, nor does it constitute any expression of opinion by the Ph. Eur. concerning the substance/preparation. This information is accordingly not to be regarded as a representation or statement concerning the quality or safety of the substance, the presence of any defect in it, or its fitness for any particular purpose except that of use as a Ph. Eur. CRS/BRP by professional persons having technical skill and at their own discretion and risk. Any recipient of this Safety Data Sheet with responsibility for other persons in a workplace should determine the risks associated with the substance according to the conditions of use and should take appropriate measures, including provision of appropriate information to persons working with the substance. Information given in sections 2, 3, 4, 5, 6, 9, 10, 11, 12, 13, 15 and 16 relates to the bulk substance and is not necessarily relevant to the CRS regarding the small quantities contained in vials. Information in sections 1, 7, 8 and 14 applies only to the CRS. People working with reference material from biological origin (human or animal) should apply State-of-the-art precautions.

Documents

MSDS-Fluorouracil[1]