Safety Data Sheet

SECTION 1. IDENTIFICATION:
Trade name: Dabrafenib, Free Base
Product Number: D-5678
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 that has not been fully tested
May be harmful if swallowed, inhaled, or absorbed through the skin
Exposure may cause irritation of the skin, eyes, mucous membranes, and upper respiratory tract
Ingestion may result in hyperkeratosis (thickening of the skin), headache, pyrexia (fever), chills, fatigue, arthralgia (joint pain), papilloma (benign epithelial tumor), alopecia (hair loss), and palmar-plantar erythrodysesthesia syndrome (also known as hand-foot syndrome manifested as redness, tenderness, peeling, blistering and ulceration of the palms and soles), pancreatitis, hypersensitivity manifesting as bullous rash (immune system disorder), interstitial nephritis (kidney disorder in which the spaces between the kidney tubules become inflamed)
Exposure may impair fertility and may be detrimental to the development of human offspring
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
H372 - Causes damage to organs through prolonged or repeated exposure
H410 - Very toxic to aquatic life with long lasting effects
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
P314 - Get medical advice/attention if you feel unwell
 


SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS:
Chemical Name: N-[3-[5-(2-Amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-4-thiazolyl]-2-fluorophenyl]-2,6-difluoro-benzenesulfonamide
Synonyms: GSK-2118436, GSK-2118436A, Tafinlar
Hazardous Ingredient: Dabrafenib, Free Base
CAS Registry Number: 1195765-45-7
Molecular Weight: 519.56
Molecular Formula: C23H20F3N5O2S2

 

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: chemical-resistant rubber gloves
Eye protection: chemical safety goggles


SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES:
Form: crystalline solid; granular or powder
Color:
Odor:
Melting point/Melting range: not tested
Danger of explosion:
Solubility in / Miscibility with water: not determined
Solvent content:
Organic solvents: soluble in DMSO

 

SECTION 10. STABILITY AND REACTIVITY:
Stability: avoid acids and bases
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


SECTION 11. TOXICOLOGICAL INFORMATION:
RTECS #: not available
Acute toxicity: oral toxicity (LD50): >1000 mg/kg (rat) - toxicity data from the GlaxoSmithKline MSDS dated September 7, 2012 for Dabrafenib Mesylate
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 respiratory tract irritation; may be harmful if inhaled
Ingestion: may be harmful if swallowed


SECTION 12. ECOLOGICAL INFORMATION:
General notes: This material may be very toxic to aquatic organisms if it is directly released into the environment


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


SECTION 14. TRANSPORT INFORMATION:
UN number: 3077
DOT: Environmentally hazardous substance, solid, n.o.s. (Dabrafenib), Marine pollutant, Class: 9, Packing group: III
IMDG: Environmentally hazardous substance, solid, n.o.s. (Dabrafenib), Class: 9, Packing group: I
IATA: Environmentally hazardous substance, solid, n.o.s. (Dabrafenib), Class: 9, Packing group: I


SECTION 15. REGULATORY INFORMATION:
Code letter and hazard designation of product:
EU Risk And Safety phrases:
S22: Do not breathe dust
S24/25: Avoid contact with skin and eyes
S26: In case of contact with eyes, rinse immediately with plenty of water and seek medical advice
S28: After contact with skin, wash immediately with plenty of water
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)
R62: Possible risk of impaired fertility
R63: Possible risk of harm to unborn child

 

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 for any damage resulting from use of this material.
Reviewed:  June 1, 2018