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MSDS Material Safety Data Sheet
CAS

358-10-4 13311-84-7

File Name: 358-10-4_13311-84-7.asp

                                                                                         1(5)

MATERIAL SAFETY DATA SHEET Date: 26.08.2004
FLUTAMIDE Supersedes: 29.01.2004




1. SUBSTANCE/PRODUCT AND COMPANY IDENTIFICATION

FLUTAMIDE

Company: Fermion Oy

Address P.O. Box 28
FIN-02101 Espoo
Finland

Tel.Int. +358-10-4291
Telefax +358-9-452 1764


2. COMPOSITION/INFORMATION ON INGREDIENTS

Chemical nature:

FLUTAMIDE 99 ?100 %

Chemical name: 2-methyl-N-[4-nitro-3-(trifluoromethyl)-
phenyl]propanamide
CAS: 13311-84-7
EINECS: 2363419

Product usage: Drug substance. Antiandrogen.


3. HAZARD IDENTIFICATION

Harmful if swallowed. Apparently harmful by inhalation and in contact with skin.


4. FIRST AID MEASURES

4.2 Inhalation: Remove to fresh air.

4.3 Skin contact: Wash with soap and plenty of water.

4.4 Eye contact: Flush with plenty of water for at least 20 minutes. Seek medical
advice.

4.5 Ingestion: Induce vomiting. Give activated charcoal. Seek medical advice.
2(5)

MATERIAL SAFETY DATA SHEET Date: 26.08.2004
FLUTAMIDE Supersedes: 29.01.2004



5. FIRE-FIGHTING MEASURES

5.1 Suitable extinguishing media:

The usual extinguishing methods are suitable.

5.3 Special exposure hazards in a fire:

Emits toxic fum es of nitrogen oxides and hydrogen fluoride in fire.


6. ACCIDENTIAL RELEASE MEASURES

6.1 Personal precautions: Warn other people about the danger of exposure. Put on the
personal safety devices.

6.3 Methods for cleaning up:

Collect the material into tight containers avoiding all exposure.
Ventilate the area and clean the place.


7. HANDLING AND STORAGE

7.1 Handling: The material should be handled with care only by specially trained
people avoiding all exposure and contamination. Pregnant women
should avoid handling this substance.

7.2 Storage: Store in airtight containers in a cool place protected from light.


8. EXPOSURE CONTROLS AND PERSONAL PROTECTION

8.2 Exposure controls

8.2.1 Occupational exposure controls:

Use only in well-ventilated areas.

8.2.1.1 Respiratory protection:

Particle filtering device (P3) or compressed air line breathing
apparatus.

8.2.1.2 Hand protection: Safety gloves.

8.2.1.3 Eye protection: Face shield or goggles.
3(5)

MATERIAL SAFETY DATA SHEET Date: 26.08.2004
FLUTAMIDE Supersedes: 29.01.2004


8.2.1.4 Skin protection: Protective clothing.


9. PHYSICAL AND CHEMICAL PROPERTIES

9.1 General information

Yellow, crystalline powder.

9.2 Important health, safety and environmental information

9.2.1 pH-value: -

9.2.2 Boiling point: -

9.2.3 Flash point: -

9.2.4 Flammability: -

9.2.5 Explosive properties

9.2.5.1 Lower explosion point:

-

9.2.5.2 Upper explosion point:

-

9.2.6 Oxidising properties: -

9.2.7 Vapour pressure: -

9.2.8 Relative density: -

9.2.9 Solubility

9.2.9.1 Water solubility: Practically insoluble in water.

9.2.9.2 Fat solubility (solvent-oil to be specified):

Freely soluble in ethanol and acetone. Soluble in chloroform.

9.2.10 Partition coefficient: n-octanol/water:

-

9.2.11 Viscosity: -

9.2.12 Vapour density: -
4(5)

MATERIAL SAFETY DATA SHEET Date: 26.08.2004
FLUTAMIDE Supersedes: 29.01.2004


9.2.13 Evaporation rate: -

9.3 Other information: Melting point: 111 ?113 篊


10. STABILITY AND REACTIVITY

Stabile in normal conditions.


11. TOXICOLOGICAL INFORMATION

11.1 Acute toxicity: LD50 = 787 mg/kg (rat, oral)

11.2 Irritation and corrosiveness:

May irritate skin, eyes and respiratory tract.

11.5 Empirical data on effects on humans:

Headache, gastro-intestinal disturbances. Possibly
methemoglobinemia. Possibly effects on the liver. Inhibition of
spermatogenesis. Abnormal spermatozoa. Infertility.


12. ECOLOGICAL INFORMATION

-


13. DISPOSAL CONSIDERATIONS

The packaging and other material that has been contaminated by Flutamide should be
handled as hazardous waste in accordance with local and state laws and instructions.


14. TRANSPORT INFORMATION

-


15. REGULATORY INFORMATION

15.1 Information on the warning label

15.1.1 Letter code of the warning symbol and indications of danger for the preparation:

Xn Harmful
5(5)

MATERIAL SAFETY DATA SHEET Date: 26.08.2004
FLUTAMIDE Supersedes: 29.01.2004


15.1.3 R-phrase(s):
R22 Harmful if swallowed.

15.1.4 S-phrase(s):
S22 Do not breathe dust.
S36/37/39 Wear suitable protective clothing and gloves.
S51 Use only in well-ventilated areas.


16. OTHER INFORMATION

16.1 List of the relevant R phrases:

Harmful if swallowed.

16.5 Sources of key data used:

Martindale: The Extra Pharmacopoeia, 31st Edition,
The Pharmaceutical Press. London 1996, 575.

16.6 Information which has been added, deleted or revised:

The information above is based on available knowledge, literature and experience and
cannot be considered as complete. For further information, please contact:

FERMION OY Address: P.O. Box 28
FIN-02101 Espoo
Tel.Int. +358-10-4291 Finland
Telefax +358-9-452 1764

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