Safety Data Sheet

SECTION 1. IDENTIFICATION:
Trade name: Gemcitabine, Hydrochloride Salt
Product Number: G-4177
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; Human Data; Reproductive Effector
May be harmful if inhaled, swallowed, or absorbed through the skin
Irritating to eyes and skin
Exposure may cause heritable genetic damage
Exposure may result in possible risk of impaired fertility and possible risk of harm to the unborn child
Ingestion may result in nausea, vomiting, edema, rash, elevated liver enzymes, and flu-like syndrome and may have adverse blood effects including decreased red blood cell counts, decreased white blood cell counts, and decreased platelet counts
Signal Word: Danger
GHS Hazard Statements:
H303 - May be harmful if swallowed
H313 - May be harmful in contact with skin H315 - Causes skin irritation
H320 - Causes eye irritation
H333 - May be harmful if inhaled
H335 - May cause respiratory irritation
H340 - May cause genetic defects
H360 - May damage fertility or the unborn child
GHS Precautionary Statements:
P261 - Avoid breathing dust/fume/gas/mist/vapours/spray
P264 - Wash skin thoroughly after handling
P273 - Avoid release to the environment
P280 - Wear protective gloves/eye protection/face protection
P301 + P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell
P330 - Rinse mouth
P302 + P352 - IF ON SKIN: Wash with plenty of soap and water
P304 + P340 - IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing
P305 + P351 + P338 - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing
P332 + P313 - If skin irritation occurs: Get medical advice/attention
P337 + P313 - If eye irritation persists: Get medical advice/attention
P308 + P311 - IF exposed or concerned: Call a POISON CENTER or doctor/physician

SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS:
Chemical Name: 4-Amino-1-[3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidin-2-one Hydrochloride
Synonyms: 2'-Deoxy-2',2'-difluorocytidine Hydrochloride, dFdC, Gamcitabine, Gemcitera, Gemsar, Gemzar, LY-188011
Hazardous Ingredient: Gemcitabine, Hydrochloride Salt
CAS Registry Number: 122111-03-9
Molecular Weight: 299.66
Molecular Formula: C9H11F2N3O4•HCl

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: chemical-resistant rubber gloves
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 25 mg/mL with slight warming; buffers, serum, or other additives may increase or decrease the aqueous solubility
Solvent content:
Organic solvents: soluble in DMSO at 12.5 mg/mL with slight warming; 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 #: HA3840000
Acute toxicity: intravenous toxicity (LD50): 500 mg/kg (mouse), 236 mg/kg (rats)
Primary irritant effect:
On the skin: causes irritation; may be harmful if absorbed through the skin
On the eye: causes irritation
Inhalation: may be harmful if inhaled
Ingestion: harmful if swallowed

SECTION 12. ECOLOGICAL INFORMATION:
General notes: Releases to the environment should be avoided
Aquatic Toxicity: (Species, Method, End Point, Duration, Result) - toxicity data from the Pfizer MSDS dated June 20, 2011 for Gemcitabine Hydrochloride
Oncorhynchus mykiss (Rainbow Trout) LC50 96 Hours > 1043 mg/L
Pimephales promelas (Fathead Minnow) LC50 96 Hours > 1014 mg/L
Daphnia Magna (Water Flea) EC50 48 Hours > 999 mg/L
Selenastrum capricornutum (Green Alga) EC50 5.4 mg/L
Bacterial Inhibition: (Inoculum, Method, End Point, Result)
Nostoc sp. (Freshwater Cyanobacteria) MIC 800 mg/L
Aspergillus niger (Fungus) MIC

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. (Gemcitabine Hydrochloride), 6.1, III
IATA: Toxic solid, organic, n.o.s. (Gemcitabine Hydrochloride), 6.1, III
IMO: Toxic solid, organic, n.o.s. (Gemcitabine Hydrochloride), 6.1, III

SECTION 15. REGULATORY INFORMATION:
Code letter and hazard designation of product:
Xn: Harmful
Xi: Irritant
EU Risk And Safety phrases:
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
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)
S53: Avoid exposure - obtain special instructions before use
R36/38: Irritating to eyes and skin
R46: May cause heritable genetic damage
R62: Possible risk of impaired fertility
R63: Possible risk of 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
Revision Date:  February 1, 2015