Safety Data Sheet

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

SECTION 1. IDENTIFICATION:
Trade name: Ceritinib, Free Base
Product Number: C-2086
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: pharmaceutically active substance that has not been fully tested
May be harmful if swallowed, inhaled, or absorbed through the skin
Ingestion may result in elevated liver enzymes (ALT/AST), nausea, diarrhea, anorexia (loss of appetite), vomiting, convulsion, pneumonia, interstitial lung disease/pneumonitis, respiratory failure, pneumothorax, dyspnea (shortness of breath), dehydration, hyperglycemia (high blood sugar), gastric hemorrhage, general physical health deterioration, pulmonary tuberculosis, cardiac tamponade, sepsis, prolonged QT interval (heart rhythm disorder), bradycardia (reduced heart rate), neuropathy comprised of paresthesia (sensation of tingling, tickling, prickling, pricking, or burning), asthenia (lack of muscle strength), gait disturbance, peripheral neuropathy, hypoesthesia (reduced sense of touch or sensation), dysesthesia (abnormal sense of touch), peripheral sensory neuropathy, neuralgia, peripheral motor neuropathy, hypotonia (decreased muscle tone), or polyneuropathy, and vision disorder comprised of vision impairment, blurred vision, photopsia (perception of flashing lights), accommodation disorder (inability of the eye to automatically change focus from distance to near objects), presbyopia (diminished ability to focus on near objects), or reduced visual acuity
Exposure may cause irritation of the skin, eyes, mucous membranes, and upper respiratory tract
Signal Word: Warning
GHS Hazard Statements:
H303 - May be harmful if swallowed
H313 - May be harmful in contact with skin
H333 - May be harmful if inhaled
H335 - May cause respiratory irritation
H372 - Causes damage to organs through prolonged or repeated exposure
H410 - Very toxic to aquatic life with long lasting effects
GHS Precautionary Statements:
P261 - Avoid breathing dust/fume/gas/mist/vapours/spray
P264 - Wash skin thoroughly after handling
P280 - Wear protective gloves/eye protection/face protection
P314 - Get medical advice/attention if you feel unwell

 

SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS:
Chemical Name: 5-Chloro-N4-[2-[(1-methylethyl)sulfonyl]phenyl]-N2-[5-methyl-2-(1-methylethoxy)-4-(4-piperidinyl)phenyl]-2,4-pyrimidinediamine
Synonyms: LDK-378, Zykadia
Hazardous Ingredient: Ceritinib, Free Base
CAS Registry Number: 1032900-25-6
Molecular Weight: 558.14
Molecular Formula: C28H36ClN5O3S


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:
Odor:
Melting point/Melting range: not tested
Danger of explosion: none
Solubility in / Miscibility with water: not determined
Solvent content:
Organic solvents: soluble in DMSO


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 (LD0): 250 mg/kg (cynomolgus monkey) - toxicity data from the Novartis MSDS dated April 30, 2014 for Zykadia
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: may be harmful if swallowed


SECTION 12. ECOLOGICAL INFORMATION:
General notes: This material may be very toxic to aquatic organisms if it is directly 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:
EU Risk And Safety phrases:
S22: Do not breathe dust
S24/25: Avoid contact with skin and eyes
S26: In case of contact with eyes, rinse immediately with plenty of water and seek medical advice
S28: After contact with skin, wash immediately with plenty of water
S36/37/39: Wear suitable protective clothing, gloves and eye/face protection


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 for any damage resulting from use of this material.
Reviewed:  June 1, 2018