MATERIAL SAFETY DATA SHEET
Product Name: Cytarabine Injection
1. CHEMICAL PRODUCT AND COMPANY INFORMATION
Hospira, Inc. Hospira Australia Pty Ltd
Manufacturer Name And
275 North Field Drive 1 Lexia Place
Address
Lake Forest, Illinois 60045 Mulgrave VIC 3170
USA AUSTRALIA
CHEMTREC: North America: 800-424-9300; International 1-703-527-3887;
Emergency Telephone #'s
Australia (02) 8014 4880
224 212-2055
Hospira, Inc., Non-Emergency
Cytarabine Injection
Material Name
4-amino-1--D-arabinofuranosyl-2(1H)-pyrimidinone; 1--D-
Synonyms
Arabinofuranosylcytosine; 4-Amino-1--D-arabinofuranosylpyrimidin-2(1H)-
one; Ara-C; Cytosar.
2. HAZARD INFORMATION / CLASSIFICATION
Cytarabine Injection contains cytarabine, a synthetic pyrimidine nucleoside anti-metabolite
Emergency Overview
used in combination chemotherapy to treat some types of cancer. It is a cytotoxic agent. In the
workplace, this preparation should be considered potentially irritating to the skin, eyes, and
respiratory tract, a potential occupational reproductive hazard, harmful to the fetus, and a
potential human carcinogen. Following an accidental over-exposure, possible target organs
may include the bone marrow, gastrointestinal tract, central nervous system, skin, eyes, lungs,
and the fetus.
There are scientific studies that suggest that personnel (e.g. nurses, pharmacists, etc.) who
Occupational Exposure
prepare and administer parenteral antineoplastics (e.g. in hospitals) may be at some risk due to
Potential
potential mutagenicity, teratogenicity, and/or carcinogenicity of these materials if workplace
exposures are not properly controlled. The actual risk in the workplace is not known.
This material should be considered irritating to the skin, eyes, and respiratory tract. In clinical
Signs and Symptoms
use, adverse effects have included severe nausea and vomiting, bone marrow depression, rash
and hair loss, pain and redness of the palms and feet, respiratory distress, and neurological
effects such as ataxia, dysphasia, and nystagmus.
Pre-existing hypersensitivity to cytarabine. Pre-existing gastrointestinal, pulmonary, skin,
Medical Conditions
central nervous system, bone marrow, and ocular ailments; pregnancy.
Aggravated by Exposure
IARC: Not listed NTP: Not listed OSHA: Not listed
Carcinogen Lists:
3. COMPOSITION/INFORMATION ON INGREDIENTS
Cytarabine
Ingredient Name
C9H13N3O5
Chemical Formula
Approximate Percent by
Component Weight CAS Number RTECS Number
Cytarabine 10 147-94-4 HA5425000
Non hazardous ingredients include water. Hazardous ingredients present at less than 1% include sodium chloride; sodium hydroxide and/or hydrochloric acid
are added to adjust the pH.
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Product Name: Cytarabine Injection
4. FIRST AID MEASURES
Remove from source of exposure. Flush with copious amounts of water. If irritation
Eye Contact
persists or signs of toxicity occur, seek medical attention. Provide
symptomatic/supportive care as necessary.
Remove from source of exposure. Flush with copious amounts of water. If irritation
Skin Contact
persists or signs of toxicity occur, seek medical attention. Provide
symptomatic/supportive care as necessary.
Remove from source of exposure. If signs of toxicity occur, seek medical attention.
Inhalation
Provide symptomatic/supportive care as necessary.
Remove from source of exposure. If signs of toxicity occur, seek medical attention.
Ingestion
Provide symptomatic/supportive care as necessary.
5. FIRE FIGHTING MEASURES
None anticipated for this aqueous product.
Flammability
None anticipated for this aqueous product.
Fire & Explosion Hazard
As with any fire, use extinguishing media appropriate for primary cause of fire.
Extinguishing Media
Firefighters should wear self-contained breathing apparatus. Protective equipment
Special Fire Fighting
and clothing should be worn to minimize contact with the respiratory tract, skin and
Procedures
eyes.
6. ACCIDENTAL RELEASE MEASURES
Put on suitable protective clothing and equipment as specified by site spill
Spill Cleanup and Disposal
procedures. Isolate area around the spill. Absorb liquid with suitable material and
clean affected area with soap and water. Dispose of materials according to the
applicable federal, state, or local regulations.
7. HANDLING AND STORAGE
Cytarabine is a cytotoxic agent. Appropriate procedures should be implemented
Handling
during the handling and disposal of cytotoxic antineoplastics agents to minimize
potential exposures. Several guidelines on handling cytotoxic antineoplastic agents
have been published. There is no general agreement that all of the procedures
recommended in the guidelines are necessary or appropriate. Consult your site
hygienist or safety professional for your site requirements.
Avoid ingestion, inhalation, skin contact, and eye contact. When handling this
product, precautions may include the use of a containment cabinet. The use of
disposable gloves and respiratory protection is recommended. Proper disposal of
contaminated vials, syringes, or other materials is required when working with this
material.
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Product Name: Cytarabine Injection
7. HANDLING AND STORAGE: continued
No special storage is required for hazard control. However, employees should be trained
Storage
on the proper storage procedures for antineoplastic agents. For product protection, follow
USP controlled room temperature storage recommendations noted on the product case
label, the primary container label, or the product insert.
Persons with known hypersensitivity to cytarabine, or who may be immunocompromised.
Special Precautions
Women who are pregnant, or women who want to become pregnant, should consult a
health and/or safety professional prior to handling this material.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Exposure Guidelines
Exposure limits
Component OSHA-PEL ACGIH-TLV Hospira EEL Other Limits
8-hr TWA: Not 8-hr TWA: Not 8-hr TWA: Not
Cytarabine NA
established established Established
Notes: OSHA PEL: US Occupational Safety and Health Administration ?Permissible Exposure Limit
ACGIH TLV: American Conference of Governmental Industrial Hygienists ?Threshold Limit Value.
EEL: Employee Exposure Limit.
TWA: 8 hour Time Weighted Average.
STEL: 15-minute Short Term Exposure Limit.
Respiratory protection is normally not needed during intended product use.
Respiratory Protection
However, if the generation of aerosols or vapors is likely, and engineering controls
are not considered adequate to control potential airborne exposures, the use of an
approved air-purifying respirator with a HEPA cartridge (N99 or equivalent) is
recommended under conditions where airborne aerosol concentrations are not
expected to be excessive. For uncontrolled release events, or if exposure levels are
not known, provide respirators that offer a high protection factor such as a powered
air purifying respirator or supplied air. A respiratory protection program that meets
OSHA's 29 CFR 1910.134 and ANSI Z88.2 requirements must be followed
whenever workplace conditions require respirator use. Personnel who wear
respirators should be fit tested and approved for respirator use as required.
When handling this material, disposable gloves should be worn at all times.
Skin Protection
Further, the use of double gloves is recommended. Disposable gloves made from
nitrile, neoprene, polyurethane or natural latex generally have low permeability to
oncolytic agents. Persons known to be allergic to latex rubber should select a non-
latex glove. Gloves should be changed regularly, and removed immediately after
known contamination. Care should be taken to minimize inadvertent contamination
when removing and/or disposing of gloves.
As a minimum, the use of chemical safety goggles is recommended when handling
Eye Protection
this material.
If the generation of aerosols is likely, local exhaust ventilation is recommended to
Engineering Controls
minimize employee exposures. The use of an enclosure, such as an approved
ventilated cabinet designed to minimize airborne exposures, is recommended.
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Product Name: Cytarabine Injection
9. PHYSICAL/CHEMICAL PROPERTIES
Clear and colorless sterile isotonic solution
Appearance/Physical State
Odorless
Odor
NA
Odor Threshold:
7.4
pH:
NA
Melting point/Freezing point:
NA
Initial Boiling Point/Boiling
Point Range
NA
Evaporation Rate:
NA
Flash Point:
NA
Flammability (solid, gas):
NA
Upper/Lower Flammability or
Explosive Limits:
NA
Vapor Pressure
NA
Vapor Density (Air =1)
NA
Evaporation Rate
NA
Specific Gravity
Soluble in water. Slightly soluble in alcohol and chloroform
Solubility
NA
Partition coefficient: n-
octanol/water:
NA
Auto-ignition temperature
NA
Decomposition temperature
10. STABILITY AND REACTIVITY
Not determined.
Reactivity
Stable under standard use and storage conditions.
Chemical Stability
Not determined
Hazardous Reactions
Not determined
Conditions to avoid
Not determined
Incompatibilities
Not determined. During thermal decomposition, it may be possible to generate
Hazardous Decomposition
irritating vapors and/or toxic fumes of carbon oxides (COx) and nitrogen
Products
oxides (NOx).
Not anticipated to occur with this product.
Hazardous Polymerization
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Product Name: Cytarabine Injection
11. TOXICOLOGICAL INFORMATION
Information for the product is not available. Information for the active ingredient (and the hydrochloride salt) is as follows:
Acute Toxicity
Ingredient(s) Route of
Percent Test Type Value Units Species
Administration
Oral
Cytarabine 100 LD50 > 5000 mg/kg Rat
Oral
Cytarabine 100 LD50 3150 mg/kg Mouse
Oral
Cytarabine Hydrochloride 100 LD50 > 3200 mg/kg Rat
Oral
Cytarabine Hydrochloride 100 LD50 826 mg/kg Mouse
Intravenous
Cytarabine 100 LD50 > 5000 mg/kg Rat
Intravenous
Cytarabine 100 LD50 > 7000 mg/kg Mouse
Intravenous
Cytarabine Hydrochloride 100 LD50 172 mg/kg Dog
Intravenous
Cytarabine Hydrochloride 100 LD50 396 mg/kg Monkey
Intraperitoneal 1000 mg/kg Rat
Cytarabine 100 LD50
> 5000 mg/kg Rat
Intraperitoneal 1000 mg/kg Mouse
Cytarabine 100 LD50
mg/kg Mouse
3379
Intraperitoneal
Cytarabine Hydrochloride 100 5500
LD50 mg/kg Rat
Intraperitoneal
Cytarabine Hydrochloride 100 825
LD50 mg/kg Mouse
LD50 is the dosage producing 50% mortality.
None anticipated from normal handling of this product.
Aspiration Hazard
None anticipated from normal handling of this product. Inadvertent skin contact with this
Dermal
product may produce irritation and redness.
Irritation/Corrosion
None anticipated from normal handling of this product. Inadvertent eye contact with this
Ocular
product may produce irritation, redness, and discomfort.
Irritation/Corrosion
None anticipated from normal handling of this product. In clinical use, allergic edema has been
Dermal or Respiratory
reported infrequently.
Sensitization
In animal studies, cytarabine was embryotoxic in mice and teratogenic in mice and rats when
Reproductive Effects
given during the period of organogenesis. In mice, cleft palate, phocomelia, deformed
appendages, and skeletal abnormalities were noted in offspring of mice given intraperitoneal
dosages 2 mg/kg/day during organogenesis. In rats, deformed appendages were noted in the
offspring after dams were given cytarabine as a single intraperitoneal dosage of 20 mg/kg on
day 12 of gestation. Reduced prenatal and postnatal brain size, and permanent impairment of
learning ability, was noted in the offspring of rats given a single intraperitoneal dosage of 50
mg/kg on day 14 of gestation. In mice, cytarabine produced embryotoxicity, characterized by
decreased fetal weight, when given at a dosage of 0.5 mg/kg/day during organogenesis; it also
caused an increase in early and late resorptions, and decreased live litter sizes, at a dosage of
8 mg/kg/day. FDA Pregnancy Category D.
Cytarabine was mutagenic in in vitro tests, and was clastogenic in vitro (chromosome
Mutagenicity
aberrations and SCE in human leukocytes) and in vivo (chromosome aberrations and SCE assay
in rodent bone marrow, mouse micronucleus assay). Cytarabine caused the transformation of
hamster embryo cells and rat H43 cells in vitro. Cytarabine caused a dose-dependent increase
in sperm-head abnormalities and chromosomal aberrations occurred in mice given
intraperitoneal cytarabine.
The carcinogenic potential of cytarabine has not been fully evaluated.
Carcinogenicity
This material should be considered irritating to the skin, eyes, and respiratory tract. Following
Target Organ Effects
an accidental over-exposure, possible target organs may include the bone marrow,
gastrointestinal tract, central nervous system, skin, eyes, lungs, and the fetus.
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Product Name: Cytarabine Injection
12. ECOLOGICAL INFORMATION
Not determined for product.
Aquatic Toxicity
Not determined for product.
Persistence/Biodegradability
Not determined for product.
Bioaccumulation
Not determined for product.
Mobility in Soil
13. DISPOSAL CONSIDERATIONS
Disposal should be performed in accordance with the federal, state or local regulatory
Waste Disposal
requirements.
Dispose of containers and unused contents in accordance with federal, state and local
Container Handling and
regulations.
Disposal
14. TRANSPORTATION INFORMATION
Not Regulated
DOT STATUS:
NA
Proper Shipping Name:
NA
Hazard Class:
NA
UN Number:
NA
Packing Group:
NA
Reportable Quantity:
Not Regulated
ICAO/IATA STATUS
NA
Proper Shipping Name:
NA
Hazard Class:
NA
UN Number:
NA
Packing Group:
NA
Reportable Quantity:
Not Regulated
IMDG STATUS
NA
Proper Shipping Name:
NA
Hazard Class:
NA
UN Number:
NA
Packing Group:
NA
Reportable Quantity:
Notes: DOT ?US Department of Transportation Regulations
15. REGULATORY INFORMATION
Exempt
TSCA Status
Not listed
CERCLA Status
Not listed
SARA 302 Status
Not listed
SARA 313 Status
Not listed
RCRA Status
This product is, or contains chemical(s) known to the State of California to cause
PROP 65 (Calif.)
developmental toxicity.
Notes: TSCA, Toxic Substance Control Act; CERCLA, US EPA law, Comprehensive Environmental Response, Compensation, and
Liability Act; SARA, Superfund Amendments and Reauthorization Act; RCRA, US EPA, Resource Conservation and Recovery Act; Prop
65, California Proposition 65.
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Product Name: Cytarabine Injection
15. REGULATORY INFORMATION: continued
Possible Irritant
U.S. OSHA Classification
Reproductive Toxin
Target Organ Toxin
*Where medicinal products are not exempt, the recommended GHS workplace
GHS Classification
classification for this product is as follows:
Acute Oral Eye Skin Toxic to Mutagenicity Target Organ Toxicity
Hazard
Toxicity Irritation Irritation Reproduction
Class
Not 2B 2 2 2 2
Hazard
Classified
Category
Symbol
Warning Warning Warning Warning Warning
Signal
Word
Causes eye Causes skin Suspected of Suspected of May cause damage to the bone
Hazard
irritation irritation damaging fertility causing genetic marrow, gastrointestinal tract,
Statement
or the unborn child defects if central nervous system, skin,
ingested. eyes, and lungs through
prolonged or repeated
exposure.
GHS Precautionary Statements:
Do not eat, drink or smoke when using this product.
Prevention:
Obtain special instructions before use.
Do not handle until all safety precautions have been read and understood.
Use personal protective equipment as required.
Avoid breathing vapors or aerosols.
In case of inadequate ventilation wear respiratory protection.
Wear protective gloves.
Wash hands thoroughly after handling.
Contaminated work clothing should not be allowed out of the workplace.
IF SWALLOWED: Call a POISON CENTER or doctor if you feel unwell.
Response:
IF INHALED: If breathing is difficult, remove to fresh air and keep at rest in a position comfortable for
breathing. If experiencing respiratory symptoms call a POISON CENTER or a doctor.
IF ON SKIN: Wash with plenty of soap and water. If skin irritation or rash occurs, seek medical
attention. Take off contaminated clothing and wash before reuse.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses if present and
easy to do. Continue rinsing. If eye irritation persists, get medical attention.
If exposed or concerned, get medical attention.
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Product Name: Cytarabine Injection
15. REGULATORY INFORMATION: continued
EU Classification
*Medicinal products are exempt from the requirements of the EU Dangerous Preparations Directive. Information
provided below is for the pure drug substance cytarabine.
Irritant Mutagen Toxic for
Classification(s):
Category 2 Reproduction
Category 2
Symbol:
Xi T T
Indication of Danger:
R36/37/38 - Irritating to eyes, respiratory system and skin
Risk Phrases:
R46 - May cause heritable genetic damage
R48/25 - Danger of serious damage to health by prolonged exposure if swallowed
R60 - May impair fertility
R61 - May cause harm to the unborn child
R64 - May cause harm to breastfed babies
S23: Do not breathe vapor or spray
Safety Phrases:
S24: Avoid contact with the skin
S36/37/39: Wear suitable protective clothing, gloves and eye/face protection.
S60: This material and its container must be disposed of as hazardous waste
16. OTHER INFORMATION
Notes: NA
ACGIH TLV American Conference of Governmental Industrial Hygienists ?Threshold Limit Value
CAS Chemical Abstracts Service Number
CERCLA US EPA law, Comprehensive Environmental Response, Compensation, and Liability Act
DOT US Department of Transportation Regulations
EEL Employee Exposure Limit
IATA International Air Transport Association
LD50 Dosage producing 50% mortality
NA Not applicable/Not available
NE Not established
NIOSH National Institute for Occupational Safety and Health
OSHA PEL US Occupational Safety and Health Administration ?Permissible Exposure Limit
Prop 65 California Proposition 65
RCRA US EPA, Resource Conservation and Recovery Act
RTECS Registry of Toxic Effects of Chemical Substances
SARA Superfund Amendments and Reauthorization Act
STEL 15-minute Short Term Exposure Limit
TSCA Toxic Substance Control Act
TWA 8-hour Time Weighted Average
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Product Name: Cytarabine Injection
16. OTHER INFORMATION: continued
MSDS Coordinator: Global Occupational Toxicology
Date Prepared: July 8, 2008
Revision Date: November 5, 2009
Disclaimer:
The information and recommendations contained herein are based upon tests believed to be reliable. However,
Hospira does not guarantee their accuracy or completeness NOR SHALL ANY OF THIS INFORMATION
CONSTITUTE A WARRANTY, WHETHER EXPRESSED OR IMPLIED, AS TO THE SAFETY OF THE
GOODS, THE MERCHANTABILITY OF THE GOODS, OR THE FITNESS OF THE GOODS FOR A
PARTICULAR PURPOSE. Adjustment to conform to actual conditions of usage may be required. Hospira
assumes no responsibility for results obtained or for incidental or consequential damages, including lost profits,
arising from the use of these data. No warranty against infringement of any patent, copyright or trademark is
made or implied.
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