Material Safety Data Sheet - Pfizer

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1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING
Material Name: Carboplatin Injection 10mg/mL
Trade Name: Not established
Chemical Family: Mixture
Intended Use: Pharmaceutical product used as Antineoplastic
2. HAZARDS IDENTIFICATION
Appearance: Clear colorless solution
Signal Word: DANGER
Statement of Hazard: Harmful if swallowed.
May damage the unborn child.
Suspected of causing genetic defects.
Additional Hazard Information:
Short Term: Harmful if swallowed (based on animal data) 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 the
developing fetus. May cause effects on blood and blood forming organs
EU Indication of danger: Harmful
Toxic to Reproduction: Category 2
Mutagenic: Category 3
EU Hazard Symbols:
EU Risk Phrases:
R22 - Harmful if swallowed.
R61 - May cause harm to the unborn child.
R68 - Possible risk of irreversible effects.
Australian Hazard Classification
(NOHSC):
Hazardous Substance. Non-Dangerous Goods.
_______________________________________________________________________________________________________
PZ01464
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: 28-Mar-2011
Emergency telephone number:
ChemSafe (24 hours): +44 (0)208 762 8322
Contact E-Mail: pfizer-MSDS@pfizer.com
Version: 1.0
MATERIAL SAFETY DATA SHEET
Page 1 of 6
Pfizer Inc
Pfizer Pharmaceuticals Group
235 East 42nd Street
New York, New York 10017
1-212-573-2222
MATERIAL SAFETY DATA SHEET
_______________________________________________________________________________________________________
2. HAZARDS IDENTIFICATION
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 %
Carboplatin 41575-94-4 255-446-0 Xn,R22; Repr.
Cat.2,R61; Muta.
Cat.3,R68
1
Ingredient CAS Number EU EINECS/ELINCS List EU Classification %
Water for Injection 7732-18-5 231-791-2 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.
_______________________________________________________________________________________________________
PZ01464
Version: 1.0
Page 2 of 6
Revision date: 28-Mar-2011
Material Name: Carboplatin Injection 10mg/mL
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 spill with absorbent material. 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: Avoid breathing vapor or mist. 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.
Analytical Method: Analytical method available for Carboplatin. Contact Pfizer Inc for further information.
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.
_______________________________________________________________________________________________________
PZ01464
Listed
ACGIH Threshold Limit Value (TWA) 0.002 mg/m3 TWA
OSHA - Final PELS - TWAs: 0.002 mg/m3
Portugal OEL - TWA Listed
Version: 1.0
Romania OEL - TWA Listed
Australia TWA 0.002 mg/m3
Slovenia OEL - TWA Listed
Page 3 of 6
Austria OEL - MAKs Listed
Carboplatin
Belgium OEL - TWA Listed
Czech Republic OEL - TWA Listed
Pfizer OEL TWA-8 Hr:
Denmark OEL - TWA Listed
0.06mg/m³
Revision date: 28-Mar-2011
Finland OEL - TWA Listed
Material Name: Carboplatin Injection 10mg/mL
Ireland OEL - TWAs
MATERIAL SAFETY DATA SHEET
_______________________________________________________________________________________________________
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Skin: Impervious protective clothing is recommended if skin contact with drug product is possible and
for bulk processing operations.
Respiratory protection: If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriate
respirator with a protection factor sufficient to control exposures to below the OEL.
9. PHYSICAL AND CHEMICAL PROPERTIES
pH: 5-7
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)
Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ)
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.
_______________________________________________________________________________________________________
PZ01464
Page 4 of 6
Carboplatin
Molecular Weight: Mixture
Embryo / Fetal Development Rat Oral 4 mg/kg/day LOAEL Fetotoxicity
Carboplatin
Embryo / Fetal Development Rat Oral 6 mg/kg/day LOAEL Fertility, Teratogenic
Rat Oral LD 50 343 mg/kg
Carboplatin
Revision date: 28-Mar-2011
In Vitro Bacterial Mutagenicity (Ames) Salmonella Positive
Rat Para-periosteal LD 50 72 mg/kg
In Vivo Mammalian Cell Mutagenicity Hamster Positive
Physical State:
In Vivo Micronucleus Mouse Positive
Solution
Rat Intraperitoneal LD 50 118 mg/kg
Material Name: Carboplatin Injection 10mg/mL
Color: Clear, colorless
Carboplatin
Version: 1.0
26 Week(s) Dog Intravenous 140 mg/kg LOAEL Bone marrow
Molecular Formula: Mixture
MATERIAL SAFETY DATA SHEET
_______________________________________________________________________________________________________
12. ECOLOGICAL INFORMATION
Environmental Overview: The environmental characteristics of this material have not been fully evaluated. Releases to
the environment should be avoided.
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: Harmful
Toxic to Reproduction: Category 2
Mutagenic: Category 3
EU Risk Phrases:
R22 - Harmful if swallowed.
R61 - May cause harm to the unborn child.
R68 - Possible risk of irreversible effects.
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
Harmful if swallowed.
May damage the unborn child.
Suspected of causing genetic defects.
Canada - WHMIS: Classifications
WHMIS hazard class:
Class D, Division 1, Subdivision B
Class D, Division 2, Subdivision B
_______________________________________________________________________________________________________
PZ01464
Material Name: Carboplatin Injection 10mg/mL
Version: 1.0
Page 5 of 6
Revision date: 28-Mar-2011
MATERIAL SAFETY DATA SHEET
_______________________________________________________________________________________________________
15. REGULATORY INFORMATION
16. OTHER INFORMATION
Text of R phrases mentioned in Section 3
R22 - Harmful if swallowed.
R61 - May cause harm to the unborn child.
R68 - Possible risks of irreversible effects.
Data Sources: Pfizer proprietary drug development information. Publicly available toxicity information.
Prepared by: Product Stewardship Hazard Communications
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
_______________________________________________________________________________________________________
PZ01464
231-791-2
Page 6 of 6
Standard for the Uniform Scheduling
for Drugs and Poisons:
Schedule 4
EU EINECS/ELINCS List 255-446-0
Revision date: 28-Mar-2011
Material Name: Carboplatin Injection 10mg/mL
Water for Injection
Carboplatin
Inventory - United States TSCA - Sect. 8(b) Listed
Version: 1.0
Australia (AICS): Listed
California Proposition 65
REACH - Annex IV - Exemptions from the
obligations of Register:
Present
Listed: Developmental Toxicity
EU EINECS/ELINCS List

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