Safety Data Sheet

SECTION 1. IDENTIFICATION:
Trade name: Tofacitinib, Free Base
Product Number: T-1377
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: Immunosuppressant
Harmful if swallowed
Ingestion may cause infections, abdominal pain, diarrhea, dyspepsia, and vomiting
May be an irritant; exposure may cause irritation to eyes, skin, mucous membranes, and upper respiratory tract
Signal Word: Danger
GHS Hazard Statements:
H302 - Harmful 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
H373 - May cause damage to organs through prolonged or repeated exposure: lymphatic system, blood/bone marrow
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
P270 - Do not eat, drink or smoke when using this product
P280 - Wear protective gloves/eye protection/face protection
P301 + P312 - IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P330 - Rinse mouth
P308 + P311 - IF exposed or concerned: Call a POISON CENTER or doctor/physician
P501 - Dispose of contents/container in accordance with local/regional/national/international regulations

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SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS:
Chemical Name: (3R,4R)-4-Methyl-3-(methyl-7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)-β-oxo-1-piperidinepropanenitrile
Synonyms: Tasocitinib, CP-690550
Hazardous Ingredient: Tofacitinib, Free Base
CAS Registry Number: 477600-75-2
Molecular Weight: 312.37
Molecular Formula: C16H20N6O

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: White to off-white
Odor: none
Melting point/Melting range: not determined
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: none
Organic solvents: soluble in DMSO at 100 mg/ml; soluble in ethanol at 100 mg/ml

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 (LDmin): 500 mg/kg (rat) - toxicity data from the Pfizer MSDS dated January 18, 2012 for Tofacitinib

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 be harmful if inhaled; may be irritating to mucous membranes and upper respiratory tract
Ingestion: 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: Wear suitable protective clothing and gloves
S53: Avoid exposure - obtain special instructions before use
R22: Harmful if swallowed
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
Revision Date:  February 1, 2015