Safety Data Sheet

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

SECTION 1. IDENTIFICATION:
Trade name: Ponatinib, Free Base
Product Number: P-7022
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 if swallowed
May be harmful if inhaled or absorbed through the skin
Ingestion may result in hypertension (elevated blood pressure), rash, pancreatitis, gastrointestinal disorders, gastrointestinal hemorrhage, abdominal pain, fatigue, headache, xeroderma (dry skin), constipation, arthralgia (joint pain), nausea, cardiovascular disorders, arterial ischemic event, myocardial infarction or worsening coronary artery disease, cardiac failure, stroke or transient ischemic attack (mini-stroke), peripheral arterial disease, hemorrhage, CNS hemorrhage, effusions including pericardial effusion, pleural effusion, and ascites, atrial fibrillation, venous thromboembolism, blood and lymphatic system disorders, pyrexia (fever), infections, pneumonia, sepsis, febrile neutropenia (development of fever/other signs of infection in association with abnormally low number of a certain type of white blood cells), myelosuppression (suppression of the bone marrow's production of blood cells and platelets), anemia, lymphopenia/leukopenia/neutropenia (reduction of different types of white blood cells), thrombocytopenia (reduced blood platelets), elevated lipase, elevated transaminases
Exposure may cause irritation of the skin, eyes, mucous membranes, and upper respiratory tract
Signal Word: Danger
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: 3-(2-imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methyl-1-piperazinyl)methyl]-3-(trifluoromethyl)phenyl]-benzamide
Synonyms: AP-24534, Iclusig
Hazardous Ingredient: Ponatinib, Free Base
CAS Registry Number: 943319-70-8
Molecular Weight: 532.56
Molecular Formula: C29H27F3N6O


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: off-white
Odor: none
Melting point/Melting range: 190-200 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 5-10 µM; buffers, serum, or other additives may increase or decrease the aqueous solubility
Solvent content:
Organic solvents: soluble in DMSO at 50 mg/mL; 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 #: not available
Acute toxicity: oral toxicity (LD50): 30-100 mg/kg (rat), 500-1000 mg/kg (mouse), >45 mg/kg (monkey) - toxicity data from the Ariad MSDS dated April 24, 2007 for AP24534
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: 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:
UN number: 2811
DOT: Toxic solid, organic, n.o.s. (pyridinyl imidazole compound), Class: 6.1, Packing group: III
IMDG: Toxic solid, organic, n.o.s. (pyridinyl imidazole compound), Class: 6.1, Packing group: III
IATA: Toxic solid, organic, n.o.s. (pyridinyl imidazole compound), Class: 6.1, Packing group: III

 

SECTION 15. REGULATORY INFORMATION:
Code letter and hazard designation of product:
T: Toxic
EU Risk And Safety phrases:
S22: Do not breathe dust
S24/25: Avoid contact with skin and eyes
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)
R25: Toxic if swallowed
R48/25: Toxic: danger of serious damage to health by prolonged exposure if swallowed
R61: May cause harm to the 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
Reviewed:  July 1, 2019