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Material Safety Data Sheet
Revision Date:  December 12, 2008

1. IDENTIFICATION OF SUBSTANCE:
Trade name: Sunitinib, Malate Salt
Product Number: S-8803
Manufacturer/Supplier:
LC Laboratories
165 New Boston Street
Woburn, MA 01801 USA
1-781-937-0777 Fax: 1-781-938-5420

2. COMPOSITION/DATA ON COMPONENTS:
Chemical Name: N-[2-(Diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide, Malate Salt
Synonyms: Sunitinib Maleate, SU-11248, Sutent, PHA-290940AD, PNU-290940AD
Hazardous Ingredient: Sunitinib, Malate Salt
CAS Registry Number: 341031-54-7
Molecular Weight: 532.56
Molecular Formula: C22H27FN4O2•C4H6O5

3. HAZARDS IDENTIFICATION:
Hazard Description: Toxic
Avoid contact with skin and eyes; avoid inhalation; do not take internally
Exposure may cause adverse effects on blood forming organs specifically bone marrow
Exposure may cause harm to the unborn child
Exposure may result in headache, nausea, and weakness/fatigue
May cause eye irritation

4. FIRST AID MEASURES:
After Inhalation: If inhaled, remove to fresh air; if breathing is difficult, give oxygen; if breathing stops, give artificial respiration
After skin contact: flush with copious amounts of water; remove contaminated clothing and shoes; call a physician
After eye contact: check for and remove contact lenses; flush with copious amounts of water; assure adequate flushing by separating the eyelids with fingers; call a physician
After swallowing: if swallowed, wash out mouth with copious amounts of water; call a physician

5. FIRE FIGHTING MEASURES:
Suitable extinguishing agents: water spray, carbon dioxide, dry chemical powder or foam
Protective equipment: wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes.
Unusual fire hazard: may emit toxic fumes under fire conditions such as carbon monoxide, etc.

6. ACCIDENTAL RELEASE MEASURES:
Person-related safety precautions: cordon off area of spill; wear self-contained breathing apparatus, protective clothing and heavy rubber gloves
Measures for cleaning/collecting: absorb solutions with finely- powdered liquid-binding material (diatomite, universal binders); decontaminate surfaces and equipment by scrubbing with alcohol; dispose of contaminated material according to Section 13

7. HANDLING AND STORAGE:
Information for safe handling: avoid contact with skin, eyes and clothing; material may be an irritant
Storage: store solid and solutions at -20 ºC

8. EXPOSURE CONTROLS AND PERSONAL PROTECTION:
Personal protective equipment as follows:
Breathing equipment: NIOSH/MSHA-approved respirator
Protection of hands: chemical-resistant rubber gloves
Eye protection: chemical safety goggles

9. PHYSICAL AND CHEMICAL PROPERTIES:
Form: solid powder
Color: yellow-orange
Odor: none
Melting point/Melting range: 194-200 ºC
Danger of explosion: none
Solubility in / Miscibility with water: very poorly soluble in water; maximum solubility in plain water is estimated to be about 10-50 µM; buffers, serum, or other additives may increase or decrease the aqueous solubility
Solvent content: none
Organic solvents: soluble in DMSO at 40 mg/mL; very poorly soluble in ethanol

10. STABILITY AND REACTIVITY:
Stability: stable if stored as directed; avoid strong oxidizing agents
Thermal decomposition / conditions to be avoided: protect from light and heat
Dangerous products of decomposition: thermal decomposition may produce toxic gases such as carbon monoxide and carbon dioxide, and nitrogen oxides

11. TOXICOLOGICAL INFORMATION:
RTECS No: not available
Acute toxicity: Adverse effects on bone marrow, blood-forming organs; toxic to developing fetus
Primary irritant effect:
On the skin: none known
On the eye: none known; may be an irritant

12. ECOLOGICAL INFORMATION:
General notes: no data available

13. DISPOSAL CONSIDERATION:
Dispose of in accordance with prevailing country, federal, state and local regulations

14. TRANSPORT INFORMATION:
DOT:
Proper shipping name: none
Non-Hazardous for transport: this substance is considered to be non-hazardous for transport
IATA class:
Proper shipping name: none
Non-Hazardous for transport: this substance is considered to be non-hazardous for transport

15. REGULATIONS:
Code letter and hazard designation of product:
T: Toxic
EU Risk And Safety phrases:
R48/25: Toxic - danger of serious damage to health by prolonged exposure if swallowed
R61: May cause harm to the unborn child
S36/37: Wear suitable protective clothing and gloves
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

16. OTHER INFORMATION:
The above information is believed to be correct based on our present knowledge but does not purport to be complete. For research use only by trained personnel. The burden of safe use of this material rests entirely with the user. LC Laboratories disclaims all liability for any damage resulting from use of this material.


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