Safety Data Sheet

SECTION 1. IDENTIFICATION:
Trade name: Pemetrexed, Disodium Salt, Heptahydrate
Product Number: P-7177
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
Harmful if swallowed, inhaled, or absorbed through the skin
Ingestion may cause adverse blood effects (including suppression of bone marrow function, thrombocytopenia (reduced blood platelets), neutropenia (reduction of a certain type of white blood cells), and anemia, nausea, vomiting, diarrhea, anorexia (decreased appetite), constipation, fatigue/drowsiness, rash, mucositis (inflammation/ulceration of the mucous membranes lining the digestive tract, especially mouth sores), and elevated liver enzymes (AST/ALT)
May be harmful to unborn child and may impair fertility
Prolonged exposure may result in serious damage to health
Vitamin B12 and Folic Acid have been shown to reduce Pemetrexed toxicity
Exposure may cause irritation to eyes, mucous membranes, upper respiratory tract, and skin
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: N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid Disodium Heptahydrate
Synonyms: Alimta, LY-231514, MTA, Rolazar, Tifolar
Hazardous Ingredient: Pemetrexed, Disodium Salt, Heptahydrate
CAS Registry Number: 357166-29-1
Molecular Weight: 597.48
Molecular Formula: C₂₀H₁₉N₅Na₂O₆•7H₂O

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 to off-white
Odor: none
Melting point/Melting range: not determined
Danger of explosion: none
Solubility in / Miscibility with water: soluble in water at 100 mg/mL; buffers, serum, or other additives may increase or decrease the aqueous solubility
Solvent content:
Organic solvents: very poorly soluble in DMSO; 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 #: LZ9950150 (for the anhydrous disodium salt)
Acute toxicity: intravenous toxicity (LD50): 1332 mg/kg (male rat); >1574 mg/kg (female rat); dermal toxicity (LD50): >1000 mg/kg (rabbit) - toxicity data from the Lilly MSDS dated Febuary 11, 2011 for Alimta
Primary irritant effect:
On the skin: causes skin irritation; may be harmful if absorbed through the skin
On the eye: may cause eye irritation
Inhalation: may be harmful if inhaled; may be an irritant
Ingestion: may be harmful if swallowed

SECTION 12. ECOLOGICAL INFORMATION:
General notes: practically non-toxic to fish, aquatic invertebrates, and green algae

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:
T: Toxic; Xi: Irritant
EU Risk And Safety phrases:
S22: Do not breathe dust
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 label where possible)
S53: Avoid exposure-obtain special instructions before use
R38: Irritating to skin
R48: Danger of serious damage to health by prolonged exposure
R60: May impair fertility
R61: May cause harm to the unborn child
R68: Possible risk of irreversible effects

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