Safety Data Sheet

SECTION 1. IDENTIFICATION:
Trade name: Crizotinib, Free Base
Product Number: C-7900
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: Harmful, Irritant
May be harmful if swallowed, inhaled, or by skin absorption
Causes serious eye irritation
May cause irritation of the skin respiratory tract, and digestive tract
Ingestion may result in severe allergic reactions ( such as rash, hives, itching, difficulty breathing, tightness in the chest, swelling of the mouth, face, lips, or tongue), burning, numbness, or tingling, changes in sense of touch, chest pain, coughing up blood, syncope (fainting), irregular heartbeat, mouth sores or swelling, severe or persistent dizziness, severe or unusual swelling, dyspnea (shortness of breath), symptoms of infection (such as fever, chills, persistent sore throat or cough), symptoms of liver problems (such as dark urine, persistent loss of appetite, right-sided stomach pain, severe or persistent tiredness, nausea, or vomiting, yellowing of the skin or eyes), trouble swallowing, unusual bruising or bleeding
Exposure may result in genetic defects
Signal Word: Danger
GHS Hazard Statements:
H303 - May be harmful if swallowed
H313 - May be harmful in contact with skin H317 - May cause an allergic skin reaction
H318 - Causes serious eye damage
H333 - May be harmful if inhaled
H335 - May cause respiratory irritation
H341 - Suspected of causing genetic defects
GHS Precautionary Statements:
P261 - Avoid breathing dust/fume/gas/mist/vapours/spray
P264 - Wash skin thoroughly after handling
P272 - Contaminated work clothing should not be allowed out of the workplace
P273 - Avoid release to the environment
P280 - Wear protective gloves/eye protection/face protection
P301 + P310: Call a POISON CENTER or doctor/physician if you feel unwell
P330 - Rinse mouth
P302 + P352 - IF ON SKIN: Wash with plenty of soap and water
P304 + P340 - IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing
P305 + P351 + P338 - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing
P332 + P313 - If skin irritation occurs: Get medical advice/attention
P337 + P313 - If eye irritation persists: Get medical advice/attention
P308 + P311 - IF exposed or concerned: Call a POISON CENTER or doctor/physician


SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS:
Chemical Name: 3-[(1R)-1-(2,6-Dichloro-3-fluorophenyl)ethoxy]-5-[1-(4-piperidinyl)-1H-pyrazol-4-yl]-2-pyridinamine
Synonyms: PF-02341066, PF-1066, PF-2341066, Xalkori
Hazardous Ingredient: Crizotinib, Free Base
CAS Registry Number: 877399-52-5
Molecular Weight: 450.34
Molecular Formula: C21H22Cl2FN5O


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: off-white
Odor: none
Melting point/Melting range: 196-207 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 10-20 µM; buffers, serum, or other additives may increase or decrease the aqueous solubility
Solvent content:
Organic solvents: soluble in DMSO at 25 mg/mL with warming; soluble in ethanol at 25 mg/mL with warming


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 #: UR8154000
Acute toxicity: oral toxicity (TDLo): 3137.5 mg/kg (mouse)
Primary irritant effect:
On the skin: may be an irritant; may be harmful if absorbed through the skin
On the eye: causes serious eye damage
Inhalation: may cause respiratory tract irritation; may be harmful if inhaled
Ingestion: may be harmful if swallowed


SECTION 12. ECOLOGICAL INFORMATION:
General notes: Very toxic to aquatic organisms
Releases to the environment should be avoided
Aquatic Toxicity: (Species, Method, End Point, Duration, Result) - toxicity data from the Pfizer MSDS dated April 19, 2013 for Crizotinib
Cyprinodon variegatus (Sheepshead Minnow) OECD LC50 96 Hours > 5.2 mg/L
Skeletonema costatum (Marine Diatom) OECD EC50 72 Hours < 0.10-0.19 mg/L
Tisbe battagliai (Marine Copepod) OECD EC50 48 Hours 0.66 mg/L
Bacterial Inhibition: (Inoculum, Method, End Point, Result)
Activated sludge OECD EC50 > 1000 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. (Crizotinib), Class: 9, Packing group: III
IMDG: Environmentally hazardous substance, solid, n.o.s. (Crizotinib), Class: 9, Packing group: III
IATA: Environmentally hazardous substance, solid, n.o.s. (Crizotinib), Class: 9, Packing group: IIII


SECTION 15. REGULATORY INFORMATION:
Code letter and hazard designation of product:
Xn: Harmful, Xi: Irritant; N: Dangerous to the environment
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)
R41: Risk of serious damage to eyes
R43: May cause sensitization by skin contact
R50: Very toxic to aquatic organisms
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