Material Safety Data Sheet - Pfizer

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1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING
Material Name: Oxaliplatin Powder for Injection
Trade Name: Not applicable
Chemical Family: Not determined
Intended Use: Pharmaceutical product used as Antineoplastic
2. HAZARDS IDENTIFICATION
Appearance: White lyophilised cake
Signal Word: DANGER
Statement of Hazard: May damage the unborn child.
May cause genetic defects.
Additional Hazard Information:
Short Term: Individuals sensitive to this chemical or other materials in its chemical class may develop
allergic reactions.
Long Term: Repeat-dose studies in animals have shown a potential to cause adverse effects on testes
and the developing fetus. May cause effects on blood and blood forming organs
Known Clinical Effects: Adverse effects most commonly reported in clinical use include vomiting nausea diarrhea bone
marrow suppression decreased red blood cell count (anemia) decreased white blood cells
(leukopenia) decrease in platelets and red/white blood cells (pancytopenia) nervous
system/brain toxicity (neurotoxicity) and skin and acute mucous membrane irritation
EU Classification
EU Indication of danger: Toxic to Reproduction: Category 2
Mutagenic: Category 2
EU Hazard Symbols:
EU Risk Phrases:
R61 - May cause harm to the unborn child.
R46 - May cause heritable genetic damage.
_______________________________________________________________________________________________________
PZ02111
Pfizer Inc
Pfizer Pharmaceuticals Group
235 East 42nd Street
New York, New York 10017
1-212-573-2222
Pfizer Ltd
Ramsgate Road
Sandwich, Kent
CT13 9NJ
United Kingdom
+00 44 (0)1304 616161
Emergency telephone number:
CHEMTREC (24 hours): 1-800-424-9300
Revision date: 07-Mar-2013
Emergency telephone number:
International CHEMTREC (24 hours): +1-703-527-3887
Contact E-Mail: pfizer-MSDS@pfizer.com
Version: 1.0
MATERIAL SAFETY DATA SHEET
Page 1 of 6
MATERIAL SAFETY DATA SHEET
_______________________________________________________________________________________________________
2. HAZARDS IDENTIFICATION
Australian Hazard Classification
(NOHSC):
Hazardous Substance. Non-Dangerous Goods.
Note: This document has been prepared in accordance with standards for workplace safety, which
require the inclusion of all known hazards of the active substance or its intermediates
regardless of the potential risk. The precautionary statements and warnings included may not
apply in all cases. Your needs may vary depending upon the potential for exposure in your
workplace.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Hazardous
Ingredient CAS Number EU EINECS/ELINCS List EU Classification %
Oxaliplatin 61825-94-3 Not Listed Repr. Cat.2,R61;
Muta. Cat.2,R46
10
Ingredient CAS Number EU EINECS/ELINCS List EU Classification %
Lactose NF, monohydrate 64044-51-5 Not Listed Not Listed *
Additional Information: * Proprietary
Ingredient(s) indicated as hazardous have been assessed under standards for workplace
safety.
For the full text of the R phrases mentioned in this Section, see Section 16
4. FIRST AID MEASURES
Eye Contact: Flush with water while holding eyelids open for at least 15 minutes. Seek medical attention
immediately.
Skin Contact: Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seek
medical attention.
Ingestion: Never give anything by mouth to an unconscious person. Wash out mouth with water. Do not
induce vomiting unless directed by medical personnel. Seek medical attention immediately.
Inhalation: Remove to fresh air and keep patient at rest. Seek medical attention immediately.
Symptoms and Effects of Exposure: For information on potential signs and symptoms of exposure, See Section 2 - Hazards
Identification and/or Section 11 - Toxicological Information.
5. FIRE FIGHTING MEASURES
Extinguishing Media: Use carbon dioxide, dry chemical, or water spray.
Hazardous Combustion Products: Formation of toxic gases is possible during heating or fire.
Fire Fighting Procedures: During all fire fighting activities, wear appropriate protective equipment, including selfcontained breathing apparatus.
Fire / Explosion Hazards: Fine particles (such as dust and mists) may fuel fires/explosions.
_______________________________________________________________________________________________________
PZ02111
Revision date: 07-Mar-2013
Material Name: Oxaliplatin Powder for Injection
Version: 1.0
Page 2 of 6
MATERIAL SAFETY DATA SHEET
_______________________________________________________________________________________________________
6. ACCIDENTAL RELEASE MEASURES
Health and Safety Precautions: Personnel involved in clean-up should wear appropriate personal protective equipment (see
Section 8). Minimize exposure.
Measures for Cleaning / Collecting: Contain the source of spill if it is safe to do so. Collect spilled material by a method that
controls dust generation. A damp cloth or a filtered vacuum should be used to clean spills of
dry solids. Clean spill area thoroughly.
Measures for Environmental
Protections:
Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to
avoid environmental release.
Additional Consideration for Large
Spills:
Non-essential personnel should be evacuated from affected area. Report emergency
situations immediately. Clean up operations should only be undertaken by trained personnel.
7. HANDLING AND STORAGE
General Handling: Minimize dust generation and accumulation. Avoid breathing dust. Avoid contact with eyes,
skin and clothing. When handling, use appropriate personal protective equipment (see Section
8). Wash hands and any exposed skin after removal of PPE. Releases to the environment
should be avoided. Review and implement appropriate technical and procedural waste water
and waste disposal measures to prevent occupational exposure or environmental releases.
Potential points of process emissions of this material to the atmosphere should be controlled
with dust collectors, HEPA filtration systems or other equivalent controls.
Storage Conditions: Store as directed by product packaging.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Refer to available public information for specific member state Occupational Exposure Limits.
Engineering Controls: Engineering controls should be used as the primary means to control exposures. General
room ventilation is adequate unless the process generates dust, mist or fumes. Keep airborne
contamination levels below the exposure limits listed above in this section.
Environmental Exposure Controls: Refer to specific Member State legislation for requirements under Community environmental
legislation.
Personal Protective Equipment: Refer to applicable national standards and regulations in the selection and use of personal
protective equipment (PPE).
Hands: Impervious gloves are recommended if skin contact with drug product is possible and for bulk
processing operations.
Eyes: Wear safety glasses or goggles if eye contact is possible.
Skin: Impervious protective clothing is recommended if skin contact with drug product is possible and
for bulk processing operations.
Respiratory protection: If airborne exposures are within or exceed the Occupational Exposure Band (OEB) range, wear
an appropriate respirator with a protection factor sufficient to control exposures to the bottom of
the OEB range.
_______________________________________________________________________________________________________
PZ02111
Pfizer Occupational Exposure
Band (OEB):
OEB 4 (control exposure to the range of 1ug/m3 to <10ug/m3)
Revision date: 07-Mar-2013
Material Name: Oxaliplatin Powder for Injection
Version: 1.0
Page 3 of 6
Oxaliplatin
MATERIAL SAFETY DATA SHEET
_______________________________________________________________________________________________________
9. PHYSICAL AND CHEMICAL PROPERTIES
10. STABILITY AND REACTIVITY
Chemical Stability: Stable under normal conditions of use.
Conditions to Avoid: Fine particles (such as dust and mists) may fuel fires/explosions.
Incompatible Materials: As a precautionary measure, keep away from strong oxidizers
11. TOXICOLOGICAL INFORMATION
General Information: The information included in this section describes the potential hazards of the active ingredient
Acute Toxicity: (Species, Route, End Point, Dose)
Acute Toxicity Comments: A greater than symbol (>) indicates that the toxicity endpoint being tested was not achievable
at the highest dose used in the test.
Irritation / Sensitization: (Study Type, Species, Severity)
Reproduction & Developmental Toxicity: (Study Type, Species, Route, Dose, End Point, Effect(s))
Genetic Toxicity: (Study Type, Cell Type/Organism, Result)
Carcinogen Status: Not listed as a carcinogen by IARC, NTP or US OSHA.
12. ECOLOGICAL INFORMATION
Environmental Overview: The environmental characteristics of this material have not been fully evaluated. Releases to
the environment should be avoided.
_______________________________________________________________________________________________________
PZ02111
Mixture
Oxaliplatin
Rat Oral LD50 > 100 mg/kg
Bacterial Mutagenicity (Ames) Salmonella Negative
Page 4 of 6
In Vitro Mammalian Cell Mutagenicity Mouse Lymphoma Positive
In Vitro Chromosome Aberration Human Lymphocytes Positive
Physical State:
In Vivo Micronucleus Mouse Bone Marrow Positive
lyophilised cake
Oxaliplatin
Revision date: 07-Mar-2013
Eye Irritation (In vitro , BCOP) Irritant
Color: White
Skin Irritation (In vitro , RhE) Negative
Material Name: Oxaliplatin Powder for Injection
Molecular Formula: Mixture
Oxaliplatin
Version: 1.0
Fertility and Embryonic Development Rat No route specified 1 mg/kg/day NOAEL Fetotoxicity
Oxaliplatin
Molecular Weight:
MATERIAL SAFETY DATA SHEET
_______________________________________________________________________________________________________
13. DISPOSAL CONSIDERATIONS
Waste Treatment Methods: Dispose of waste in accordance with all applicable laws and regulations. Member State
specific and Community specific provisions must be considered. Considering the relevant
known environmental and human health hazards of the material, review and implement
appropriate technical and procedural waste water and waste disposal measures to prevent
occupational exposure and environmental release. It is recommended that waste minimization
be practiced. The best available technology should be utilized to prevent environmental
releases. This may include destructive techniques for waste and wastewater.
14. TRANSPORT INFORMATION
The following refers to all modes of transportation unless specified below.
Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations.
15. REGULATORY INFORMATION
EU Symbol: T
EU Indication of danger: Toxic to Reproduction: Category 2
Mutagenic: Category 2
EU Risk Phrases:
R61 - May cause harm to the unborn child.
R46 - May cause heritable genetic damage.
EU Safety Phrases:
S22 - Do not breathe dust.
S53 - Avoid exposure - obtain special instructions before use.
S36/37 - Wear suitable protective clothing and gloves.
OSHA Label:
DANGER
May damage the unborn child.
May cause genetic defects.
Canada - WHMIS: Classifications
WHMIS hazard class:
Class D, Division 2, Subdivision B
_______________________________________________________________________________________________________
PZ02111
Material Name: Oxaliplatin Powder for Injection
Version: 1.0
Page 5 of 6
Revision date: 07-Mar-2013
MATERIAL SAFETY DATA SHEET
_______________________________________________________________________________________________________
15. REGULATORY INFORMATION
16. OTHER INFORMATION
Text of R phrases mentioned in Section 3
R46 - May cause heritable genetic damage.
R61 - May cause harm to the unborn child.
Data Sources: Publicly available toxicity information.
Prepared by: Product Stewardship Hazard Communication
Pfizer Global Environment, Health, and Safety Operations
Pfizer Inc believes that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, it
is without warranty of any kind, expressed or implied. If data for a hazard are not included in this document there is no known
information at this time.
End of Safety Data Sheet
_______________________________________________________________________________________________________
PZ02111
Standard for the Uniform Scheduling
for Drugs and Poisons:
Schedule 4
Version: 1.0
Page 6 of 6
Lactose NF, monohydrate
Australia (AICS): Present
Revision date: 07-Mar-2013
Oxaliplatin
Material Name: Oxaliplatin Powder for Injection

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