Safety Data Sheet

SAFETY DATA SHEET - LC LABORATORIES
REVISION DATE: JULY 1, 2019

SECTION 1. IDENTIFICATION:
Trade name: Erlotinib, Methanesulfonate Salt
Product Number: E-4667
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
Substance Class Identifier: Tumorigen; Drug
Harmful if swallowed
May be harmful if inhaled or through skin absorption
Ingestion may result in rash, dry skin, pruirits (itch), diarrhea, nausea, vomiting, stomach pain, anorexia (decreased appetite), weight loss, fatigue, dyspnea (shortness of breath), stomatitis (inflammation/ulceration of the mucous membranes lining of the mouth), cough, liver failure, kidney failure, increased bleeding rates, gastrointestinal perforation, and corneal perforation or ulceration
May be irritating to skin, eyes, mucous membranes, and upper respiratory tract
Signal Word: Warning
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
Harmful

 

SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS:
Chemical Name: N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine Methanesulfonate
Synonyms: CP-358774, NSC-718781, OSI-774, R1415, Tarceva
Hazardous Ingredient: Erlotinib, Methanesulfonate Salt
CAS Registry Number: 248594-19-6
Molecular Weight: 489.54
Molecular Formula: C22H23N3O4•CH4SO3


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 and 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: emits toxic fumes 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: none
Melting point/Melting range: not determined
Danger of explosion: none
Solubility in / Miscibility with water: not determined
Solvent content: none
Organic solvents: soluble in DMSO


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 #: VA0971200 for HCl salt form
Acute toxicity: oral toxicity (LD50): 1000-2000 mg/kg (rat), >2000 mg/kg (mouse); dermal toxicity (LD50): >2000 mg/kg (rabbit) - toxicity data is from the Hoffman-La Roche MSDS dated January 11, 2011 for Tarceva
Primary irritant effect: none known
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: May cause long lasting harmful effects to aquatic life - following toxicity data is from the Hoffman-La Roche MSDS dated January 11, 2011 for Tarceva
Ready biodegradability - not readily biodegradable
0 %, 28 d
(MITI Test I, OECD No. 301 C)
Inherent biodegradability - not inherently biodegradable
0 %, 28 d
(Roche-internal respirometric inherent biodegradation test)
Ecotoxicity - barely toxic for algae (nominal concentration = 100 mg/l), test performed with water accommodated fractions (Selenastrum capricornutum)
EC50 (72 h) > 100 mg/l (nominal concentration)
NOEC (72 h) 1.39 mg/l (saturation concentration) (OECD No. 201)
Ecotoxicity - barely toxic for planktonic crustaceans (nominal concentration = 100 mg/l), test performed with water accommodated fractions (Daphnia magna)
EC50 (48 h) > 100 mg/l (nominal concentration)
EC10 (48 h) 1.53 mg/l (saturation concentration)
NOEC (48 h) 0.70 mg/l (average measured concentration) (OECD No. 202)
Ecotoxicity - barely toxic for fish (nominal concentration = 100 mg/l), test performed with water accommodated fractions (zebrafish) LC50 (96 h) > 100 mg/l (nominal concentration)
LC0 (96 h) 1.80 mg/l (saturation concentration)
(OECD No. 203, semi-static)
Ecotoxicity - barely toxic for microorganisms (nominal concentration > 100 mg/l)
(activated sludge)
NOEC (3 h) 1000 mg/l (nominal concentration) (Activated Sludge Respir. Inhib. Test, OECD No. 209)


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
S36/37/39: 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)
R22: Harmful if swallowed
R53: May cause long-term adverse effects in the aquatic environment


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