Safety Data Sheet

Safety Data Sheet - LC Laboratories
Revision Date: July 1, 2019

SECTION 1. IDENTIFICATION:
Trade name: Ruxolitinib, Phosphate Salt
Product Number: R-6688
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
Harmful if swallowed
May be harmful if inhaled or through skin absorption
Ingestion may result in thrombocytopenia (reduced blood platelets), neutropenia (reduction of a certain type of white blood cells), anemia, bruising/unusual bleeding, dizziness, headache, fatigue, dyspnea (shortness of breath), infection involving chills, aches, fever, nausea, vomiting, weakness, painful skin rash or blisters
Prolonged exposure may result in serious damage to health
Prolonged exposure may result in serious damage to health
Exposure may adversely affect fetal development and may impair fertility
May be irritating to skin, eyes, mucous membranes, and upper respiratory tract
Signal Word: Warning
GHS Hazard Statements:
H302+312+332 - Harmful if swallowed, in contact with skin or if inhaled
GHS Precautionary Statements:
P2562 - Do not get in eyes, on skin or on clothing
WARNING: For Laboratory Research Use Only

 

SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS:
Chemical Name: (βR)-β-Cyclopentyl-4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazole-1-propanenitrile phosphate
Synonyms: INCB018424, INCB18424, NCB018424, NCB18424, Jakafi
Hazardous Ingredient: Ruxolitinib, Phosphate Salt
CAS Registry Number: 1092939-17-7
Molecular Weight: 404.36
Molecular Formula: C17H18N6•H3O4P


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
Odor: none
Melting point/Melting range: not determined
Danger of explosion: none
Solubility in / Miscibility with water: soluble in water at 8 mg/mL with warming; buffers, serum, or other additives may increase or decrease the aqueous solubility
Solvent content:
Organic solvents: soluble in DMSO at 200 mg/mL; very poorly soluble in ethanol


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): 250 mg/kg (rat) - toxicity data from the Incyte MSDS dated May 12, 2014 for Jakafi
Primary irritant effect:
On the skin: may cause skin irritation
On the eye: may cause eye irritation
Inhalation: may be an irritant; may be harmful if inhaled
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
Hazard-determining components of labeling:
EU Risk And Safety phrases: 
S22: Do not breathe dust
S36/37: Wear suitable protective clothing and gloves
S45: In case of accident or if you feel unwell, seek medical advice immediately (show label where possible)
R48/22: Harmful: danger of serious damage to health by prolonged exposure 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
Reviewed:  July 1, 2019