Section I.Chemical Product and Company Identification
Chemical Name Gemcitabine Hydrochloride
Portland OR
Synonym Cytidine, 2'-deoxy-2',2'-difluoro-, hydrochloride (1:1)
(CA INDEX NAME)
Chemical Formula C9H11F2N3O4 · HCl
CAS Number 122111-03-9
Section II. Composition and Information on Ingredients
Toxicology Data
Chemical Name CAS Number Percent (%) TLV/PEL
Min. 98.0 Not available. Rat LD50 (intravenous) 236 mg/kg
Gemcitabine Hydrochloride 122111-03-9
(HPLC,N) Mouse LD50 (intravenous) 500
mg/kg
Section III. Hazards Identification
Irritating to eyes and skin on contact. Inhalation causes irritation of the lungs and respiratory system. Inflammation of the
Acute Health Effects
eye is characterized by redness, watering, and itching. Skin inflammation is characterized by itching, scaling, reddening, or,
occasionally, blistering.
Follow safe industrial hygiene practices and always wear proper protective equipment when handling this compound.
CARCINOGENIC EFFECTS : Not available.
Chronic Health Effects
MUTAGENIC EFFECTS : Not available.
TERATOGENIC EFFECTS : Not available.
DEVELOPMENTAL TOXICITY: Reproductive effects.
Mouse TDLo Intravenous 15 mg/kg, female 6-15 days of pregnancy
Toxic Effects:
Maternal Effects - Parturition
Effects on Fertility - Post-implantation mortality
Effects on Fertility - Litter size
Mouse TDLo Intravenous 15 mg/kg, female 6-15 days of pregnancy
Toxic Effects:
Maternal Effects - Other effects
Effects on Embryo or Fetus - Fetotoxicity
Effects on Embryo or Fetus - Fetal death
Repeated or prolonged exposure to this compound is not known to aggravate existing medical conditions.
Section IV. First Aid Measures
Eye Contact Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15
minutes. Get medical attention.
Skin Contact In case of contact, immediately flush skin with plenty of water. Remove contaminated clothing and shoes. Wash clothing
before reuse. Thoroughly clean shoes before reuse. Get medical attention.
If the victim is not breathing, perform mouth-to-mouth resuscitation. Loosen tight clothing such as a collar, tie, belt or
Inhalation
waistband. If breathing is difficult, oxygen can be administered. Seek medical attention if respiration problems do not
improve.
INDUCE VOMITING by sticking finger in throat. Lower the head so that the vomit will not reenter the mouth and throat.
Ingestion
Loosen tight clothing such as a collar, tie, belt or waistband. If the victim is not breathing, perform mouth-to-mouth
resuscitation. Examine the lips and mouth to ascertain whether the tissues are damaged, a possible indication that the toxic
material was ingested; the absence of such signs, however, is not conclusive.
Section V. Fire and Explosion Data
Not available.
May be combustible at high temperature. Auto-Ignition
Flammability
Flash Points Flammable Limits Not available.
Not available.
These products are toxic carbon oxides (CO, CO2), nitrogen oxides (NO, NO2), halogenated compounds.
Combustion Products
WARNING: Highly toxic HCl gas is produced during combustion.
WARNING: Highly toxic HF gas is produced during combustion.
Fire Hazards
Not available.
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Gemcitabine Hydrochloride
Explosion Hazards Risks of explosion of the product in presence of mechanical impact: Not available.
Risks of explosion of the product in presence of static discharge: Not available.
Fire Fighting Media SMALL FIRE: Use DRY chemical powder.
LARGE FIRE: Use water spray, fog or foam. DO NOT use water jet.
and Instructions
Consult with local fire authorities before attempting large scale fire-fighting operations.
Section VI. Accidental Release Measures
Spill Cleanup Irritating material. This material is a reproductive effector.
Use a shovel to put the material into a convenient waste disposal container. Consult federal, state, and/or local authorities for
Instructions
assistance on disposal.
Section VII. Handling and Storage
IRRITANT. REPRODUCTIVE EFFECTOR. Keep away from heat. Mechanical exhaust required. When not in use, tightly
Handling and Storage
seal the container and store in a dry, cool place. Avoid excessive heat and light. Do not breathe dust.
Information
Always store away from incompatible compounds such as oxidizing agents.
Section VIII. Exposure Controls/Personal Protection
Engineering Controls Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommended
exposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure to airborne contaminants
below the exposure limit.
Personal Protection Splash goggles. Lab coat. Dust respirator. Boots. Gloves. Suggested protective clothing might not be sufficient; consult a
specialist BEFORE handling this product. Be sure to use a MSHA/NIOSH approved respirator or equivalent.
Not available.
Exposure Limits
Section IX. Physical and Chemical Properties
Physical state @ 20°C Solid. (White crystalline powder.) Solubility Soluble in hot water.
Not available.
Specific Gravity
Molecular Weight 299.66 Partition Coefficient Not available.
Boiling Point Not available. Not applicable.
Vapor Pressure
Melting Point 287 to 292°C (548.6 to 557.6°F) (dec.) Vapor Density Not available.
Not available. Not available.
Refractive Index Volatility
Critical Temperature Not available. Odor Not available.
Not available. Not available.
Viscosity Taste
Section X. Stability and Reactivity Data
This material is stable if stored under proper conditions. (See Section VII for instructions)
Stability
Conditions of Instability Avoid excessive heat and light.
Incompatibilities Reactive with oxidizing agents.
Section XI. Toxicological Information
RTECS Number HA3840000
Eye Contact. Ingestion. Inhalation.
Routes of Exposure
Rat LD50 (intravenous) 236 mg/kg
Toxicity Data
Mouse LD50 (intravenous) 500 mg/kg
CARCINOGENIC EFFECTS : Not available.
Chronic Toxic Effects
MUTAGENIC EFFECTS : Not available.
TERATOGENIC EFFECTS : Not available.
DEVELOPMENTAL TOXICITY: Reproductive effects.
Mouse TDLo Intravenous 15 mg/kg, female 6-15 days of pregnancy
Toxic Effects:
Maternal Effects - Parturition
Effects on Fertility - Post-implantation mortality
Effects on Fertility - Litter size
Mouse TDLo Intravenous 15 mg/kg, female 6-15 days of pregnancy
Toxic Effects:
Maternal Effects - Other effects
Effects on Embryo or Fetus - Fetotoxicity
Effects on Embryo or Fetus - Fetal death
Repeated or prolonged exposure to this compound is not known to aggravate existing medical conditions.
Continued on Next Page
Gemcitabine Hydrochloride
Acute Toxic Effects Irritating to eyes and skin on contact. Inhalation causes irritation of the lungs and respiratory system. Inflammation of the eye
is characterized by redness, watering, and itching. Skin inflammation is characterized by itching, scaling, reddening, or,
occasionally, blistering.
Follow safe industrial hygiene practices and always wear proper protective equipment when handling this compound.
Section XII. Ecological Information
Not available.
Ecotoxicity
Environmental Fate Not available.
Section XIII. Disposal Considerations
Recycle to process, if possible. Consult your local regional authorities. You may be able to dissolve or mix material with a
Waste Disposal
combustible solvent and burn in a chemical incinerator equipped with an afterburner and scrubber system. Observe all
federal, state and local regulations when disposing of the substance.
Section XIV. Transport Information
DOT Classification Not a DOT controlled material (United States).
PIN Number Not applicable.
Proper Shipping Name Not applicable.
Packing Group (PG) Not applicable.
DOT Pictograms
Section XV. Other Regulatory Information and Pictograms
TSCA Chemical Inventory This product is NOT on the EPA Toxic Substances Control Act (TSCA) inventory. The following notices are required by 40
CFR 720.36 (C) for those products not on the inventory list:
(EPA)
(i) These products are supplied solely for use in research and development by or under the supervision of a technically
qualified individual as defined in 40 CFR 720.0 et sec.
(ii) The health risks of these products have not been fully determined. Any information that is or becomes available will be
supplied on an MSDS sheet.
WHMIS Classification Not available.
(Canada)
EINECS Number (EEC) 601-823-3
EEC Risk Statements R36/37/38- Irritating to eyes, respiratory system and skin.
R60- May impair fertility.
R61- May cause harm to the unborn child.
SECTION 16 - ADDITIONAL INFORMATION
N/A
