Safety Data Sheet

SAFETY DATA SHEET - LC LABORATORIES
REVISION DATE: JUNE 1, 2018

SECTION 1. IDENTIFICATION:
Trade name: Axitinib, Free Base
Product Number: A-1107
Manufacturer/Supplier:
LC Laboratories
165 New Boston Street
Woburn, MA 01801 USA
1-781-937-0777 Fax: 1-781-938-5420


SECTION 2. HAZARD(S) IDENTIFICATION:
Hazard Description: pharmaceutically active substance
May be harmful if swallowed, inhaled, or absorbed through the skin
Ingestion may result in fatigue, proteinuria (presence of protein in the urine), nausea, vomiting, diarrhea, anorexia (decreased appetite), stomatitis/mucositis (inflammation/ulceration of the mucous membranes lining of the mouth and digestive tract), hypertension (elevated blood pressure), palmar-plantar erythrodysesthesia syndrome (also known as hand-foot syndrome manifested as redness, tenderness, peeling, blistering and ulceration of the palms and soles), and constipation
Exposure may cause irritation of the skin, eyes, mucous membranes, and upper respiratory tract
Signal Word: Warning
GHS Hazard Statements:
H303 - May be harmful if swallowed
H313 - May be harmful in contact with skin
H333 - May be harmful if inhaled
H335 - May cause respiratory irritation
H341 - Suspected of causing genetic defects
H361 - Suspected of damaging fertility or the unborn child
GHS Precautionary Statements:
P261 - Avoid breathing dust/fume/gas/mist/vapours/spray
P264 - Wash skin thoroughly after handling
P280 - Wear protective gloves/eye protection/face protection
P308 + P311 - IF exposed or concerned: Call a POISON CENTER or doctor/physician
P314 - Get medical advice/attention if you feel unwell
P501 - Dispose of contents/container in accordance with local/regional/national/international regulations


SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS:
Chemical Name: N-methyl-2-[[3-[(1E)-2-(pyridin-2-yl)ethenyl]-1H-indazol-6-yl]sulfanyl]benzamide
Synonyms: AG-013736, D03218, Inlyta
Hazardous Ingredient: Axitinib, Free Base
CAS Registry Number: 319460-85-0
Molecular Weight: 386.47
Molecular Formula: C22H18N4OS

 

SECTION 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


SECTION 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.


SECTION 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


SECTION 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


SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION:
Personal protective equipment as follows:
Breathing equipment: NIOSH/MSHA-approved respirator
Protection of hands: handle with Nitrile rubber gloves with minimum thickness of 0.11 mm (4.3 mil). This recommendation should not be interpreted as offering an approval for any specific use conditions. Please review this recommendation with a safety officer to evaluate if it is appropriate for the anticipated use.
Eye protection: chemical safety goggles


SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES:
Form: crystalline solid; granular or powder
Color: white to off-white
Odor: none
Melting point/Melting range: 213-224 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 33 mg/mL; soluble in ethanol at 1.7 mg/mL with warming


SECTION 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, carbon dioxide, and nitrogen oxides


SECTION 11. TOXICOLOGICAL INFORMATION:
RTECS #: not available
Acute toxicity: oral toxicity (NOAEL): 2000 mg/kg (mouse), >2000 mg/kg (dog) - toxicity data from the Pfizer MSDS dated January 11, 2012 for Axitinib tablets
Primary irritant effect:
On the skin: may be an irritant; may be harmful if absorbed through the skin
On the eye: may be an irritant
Inhalation: may cause irritation to mucous membranes and upper respiratory tract; may be harmful if inhaled
Ingestion: may cause irritation to the upper digestive tract; may be harmful if swallowed


SECTION 12. ECOLOGICAL INFORMATION:
General notes: no data available
Treat as potentially toxic if released into the environment


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


SECTION 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

 

SECTION 15. REGULATORY INFORMATION:
Code letter and hazard designation of product:
Xn: Harmful
EU Risk And Safety phrases:
S22: Do not breathe dust
S24/25: Avoid contact with skin and eyes
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)
R46: May cause inheritable genetic damage
R62: Possible risk of impaired fertility
R63: Possible risk of harm to the unborn child
R68: Possible risk of irreversible effects


SECTION 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
Reviewed:  June 1, 2018