Safety Data Sheet

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

SECTION 1. IDENTIFICATION:
Trade name: Dasatinib
Product Number: D-3307
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: Toxic
Toxic if swallowed
May be harmful if inhaled or absorbed through the skin
Ingestion may cause damage to any/all of the following systems: hematologic, gastrointestinal, central nervous system, musculoskeletal, respiratory, metabolic-nutritional, hepatic, cardiovascular, dermatologic, renal
May damage fertility and/or the unborn child and breastfed infant
Exposure may cause irritation of the skin, eyes, mucous membranes, and upper respiratory tract
Signal Word: Danger
GHS Hazard Statements:
H301 - Toxic if swallowed
H313 - May be harmful in contact with skin
H333 - May be harmful if inhaled
H335 - May cause respiratory irritation
H360 - May damage fertility or the unborn child
H372 - Causes damage to organs through prolonged or repeated exposure: gastrointestinal tract, bone marrow, immune system, lungs, eyes
H373 - May cause damage to organs through prolonged or repeated exposure: uterus, ovaries, testicles
H410 - Very toxic to aquatic life with long lasting effects
GHS Precautionary Statements:
P201 - Obtain special instructions before use
P202 - Do not handle until all safety precautions have been read and understood
P260 - Do not breathe dust/fume/gas/mist/vapours/spray
P264 - Wash any exposed skin thoroughly after handling
P273 - Avoid release to the environment
P280 - Wear protective gloves/eye protection/face protection
P301 + P310 - IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician
P330 - Rinse mouth
P302 + P352 - IF ON SKIN: Wash with plenty of soap and water
P305 + P351 + P338 - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing
P308 + P313 - IF exposed or concerned: Get medical advice/attention
P314 - Get medical advice/attention if you feel unwell
 


SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS:
Chemical Name: N-(2-Chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide
Synonyms: BMS-354825, Sprycel
Hazardous Ingredient: Dasatinib
CAS Registry Number: 302962-49-8
Molecular Weight: 488.01
Molecular Formula: C22H26CIN7O2S


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 and 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: emits toxic fumes 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: off-white to pale yellow
Odor: none
Melting point/Melting range: 261-285 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 µM; buffers, serum, or other additives may increase or decrease the aqueous solubility
Solvent content: none
Organic solvents: soluble in DMSO at 200 mg/mL; very poorly soluble in ethanol


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 #: XJ3466000
Acute toxicity: oral toxicity (LD50): 50-100 mg/kg (rat), 24-45 mg/kg (monkey) - toxicity data from the Bristol-Myers Squibb MSDS dated May 15, 2013 for Dasatinib
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: toxic if swallowed

 

SECTION 12. ECOLOGICAL INFORMATION:
General notes: Very toxic to aquatic organisms
Releases to the environment should be avoided
Acute Toxicity to Fish - toxicity data from the Bristol-Myers Squibb MSDS dated May 15, 2013 for Dasatinib
LC50 (Oncorhynchus mykiss (rainbow trout), 96 H) : > 0.50 mg a.i./L. (limit of solubility)
NOEC (Oncorhynchus mykiss (rainbow trout), 96 H) : 0.50 mg a.i./L. (limit of solubility)
Toxicity to aquatic plants
EC50 (Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum), Algae biomass, 72 H) : 0.14 mg/l
NOEC (Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum), Algae biomass, 72 H) : 0.03 mg/l
EC50 (Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum), Algae growth rate, 72 H) : > 0.18 mg/l (limit of solubility)
NOEC (Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum), Algae growth rate, 72 H) : 0.073 mg/l
Toxicity to microorganisms
Respiration inhibition, EC50 (Activated Sludge, 3 H) : > 1,000 mg/l
Chronic toxicity to fish
Early-life Stage LOEC (Pimephales promelas (fathead minnow)) : 0.018 mg/l NOEC : 0.034 mg/l
Chronic toxicity to aquatic invertabrates
LOEC (Daphnia magna (Water flea), 21 D) : 0.17 mg/l (limit of solubility) NOEC (Daphnia magna (Water flea), 21 D) : 0.068 mg/l


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. (Dasatinib), Class: 9, Packing group: III
IMDG: Environmentally hazardous substance, solid, n.o.s. (Dasatinib), Class: 9, Packing group: III
IATA: Environmentally hazardous substance, solid, n.o.s. (Dasatinib), Class: 9, Packing group: IIII

 

SECTION 15. REGULATORY INFORMATION:
Code letter and hazard designation of product:
T: Toxic; N: Dangerous to the environment
EU Risk And Safety phrases:
S22: Do not breathe dust
S29: Do not empty into drains
S36/37/39: Wear suitable protective clothing, gloves, and eye/face protection
S38: In case of insufficient ventilation, wear suitable respiratory equipment
S45: In case of accident or if you feel unwell, seek medical advice immediately (show label where possible)
S53: Avoid exposure - obtain special instructions before use
R25: Toxic if swallowed
R40: Limited evidence of a carcinogenic effect
R48/25: Toxic: danger of serious damage to health by prolonged exposure if swallowed
R51/53: Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment
R61: May cause harm to the unborn child
R62: Possible risk of impaired fertility


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