SAFETY DATA SHEET

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1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND THE COMPANY/UNDERTAKING

Product Identifier
Material Name: Busulfan Injection (Hospira, Inc)
Trade Name: Not established
Chemical Family: Not determined

Relevant Identified Uses of the Substance or Mixture and Uses Advised Against
Intended Use: Pharmaceutical product used as Antineoplastic

Details of the Supplier of the Safety Data Sheet

Pfizer Inc Pfizer Ltd
Pfizer Pharmaceuticals Group Ramsgate Road
235 East 42nd Street Sandwich, Kent
New York, New York 10017 CT13 9NJ
1-800-879-3477 United Kingdom
+00 44 (0)1304 616161
Emergency telephone number: Emergency telephone number:
CHEMTREC (24 hours): 1-800-424-9300 International CHEMTREC (24 hours): +1-703-527-3887
Contact E-Mail: pfizer-MSDS@pfizer.com

2. HAZARDS IDENTIFICATION

Classification of the Substance or Mixture

GHS - Classification
Serious Eye Damage/Eye Irritation: Category 2A
Germ Cell Mutagenicity: Category 1B
Reproductive Toxicity: Category 1B
Carcinogenicity: Category 1B

Label Elements
Signal Word: Danger
Hazard Statements: H319 - Causes serious eye irritation
H350 - May cause cancer
H360FD - May damage fertility. May damage the unborn child.
H340 - May cause genetic defects

Precautionary Statements: P201 - Obtain special instructions before use

P202 - Do not handle until all safety precautions have been read and understood
P264 - Wash hands thoroughly after handling
P280 - Wear protective gloves/protective clothing/eye protection/face protection
P308 + P313 - IF exposed or concerned: Get medical attention/advice
P337 + P313 - If eye irritation persists: Get medical advice/attention
P405 - Store locked up

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Other Hazards An Occupational Exposure Value has been established for one or more of the ingredients (see
Section 8).

Note: This document has been prepared in accordance with standards for workplace safety, which
requires the inclusion of all known hazards of the product or its ingredients regardless of the
potential risk. The precautionary statements and warning 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 GHS Classification %
EINECS/ELINCS
List
Busulfan 55-98-1 200-250-2 Repr. 1B (H360FD) <1
Carc. 1B (H350)
Muta. 1B (H340)
N,N-DIMETHYLACETAMIDE 127-19-5 204-826-4 Repr. 1B (H360D) 30 - 35
Acute Tox. 4 (H312)
Acute Tox. 4 (H332)
Eye Irrit. 2A (H319)

Ingredient CAS Number EU GHS Classification %

EINECS/ELINCS
List
Polyethylene glycol 25322-68-3 Not Listed Not Listed *

Additional Information: Ingredient(s) indicated as hazardous have been assessed under standards for workplace
safety.

For the full text of the CLP/GHS abbreviations mentioned in this Section, see Section 16

4. FIRST AID MEASURES

Description of 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.

Most Important Symptoms and Effects, Both Acute and Delayed

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Symptoms and Effects of No data available

Exposure:
Medical Conditions None known
Aggravated by Exposure:

Indication of the Immediate Medical Attention and Special Treatment Needed

Notes to Physician: None

5. FIRE FIGHTING MEASURES

Extinguishing Media: Extinguish fires with CO2, extinguishing powder, foam, or water.

Special Hazards Arising from the Substance or Mixture

Hazardous Combustion Formation of toxic gases is possible during heating or fire.
Products:

Fire / Explosion Hazards: Fine particles (such as mists) may fuel fires/explosions.

Advice for Fire-Fighters

During all firefighting activities, wear appropriate protective equipment, including self-contained breathing apparatus.

6. ACCIDENTAL RELEASE MEASURES

Personal Precautions, Protective Equipment and Emergency Procedures

Personnel involved in clean-up should wear appropriate personal protective equipment (see Section 8). Minimize exposure.

Environmental Precautions
Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to avoid environmental release.

Methods and Material for Containment and Cleaning Up

Measures for Cleaning / Contain the source of spill if it is safe to do so. Collect spill with absorbent material. Clean spill
Collecting: area thoroughly.

Additional Consideration for Non-essential personnel should be evacuated from affected area. Report emergency
Large Spills: situations immediately. Cleanup operations should only be undertaken by trained personnel.

7. HANDLING AND STORAGE

Precautions for Safe Handling

Avoid breathing vapor or mist. Avoid contact with eyes, skin and clothing. When handling, use appropriate personal protective
equipment (see Section 8). Wash thoroughly after handling. 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.

Conditions for Safe Storage, Including any Incompatibilities

Storage Conditions: Store as directed by product packaging.
Specific end use(s): Pharmaceutical product used as Antineoplastic

8. EXPOSURE CONTROLS / PERSONAL PROTECTION

Control Parameters
Refer to available public information for specific member state Occupational Exposure Limits.

N,N-DIMETHYLACETAMIDE
ACGIH Threshold Limit Value (TWA) 10 ppm

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8. EXPOSURE CONTROLS / PERSONAL PROTECTION

ACGIH - Biological Exposure Limit: 30 mg/g creatinine
ACGIH - Skin Absorption Designation Skin - potential significant contribution to overall exposure by the
cutaneous route
Australia TWA 10 ppm
36 mg/m3
Austria OEL - MAKs 10 ppm
36 mg/m3
Belgium OEL - TWA 10 ppm
36 mg/m3
Bulgaria OEL - TWA 10 ppm
36 mg/m3
Cyprus OEL - TWA 10 ppm
36 mg/m3
Czech Republic OEL - TWA 30 mg/m3
Denmark OEL - TWA 10 ppm
36 mg/m3
Estonia OEL - TWA 10 ppm
36 mg/m3
Finland OEL - TWA 10 ppm
36 mg/m3
France OEL - TWA 2 ppm
7.2 mg/m3
Germany - TRGS 900 - TWAs 10 ppm
36 mg/m3
Germany (DFG) - MAK 10 ppm
36 mg/m3
Germany - Biological Exposure Limit: 30 mg/g
Greece OEL - TWA 10 ppm
36 mg/m3
Hungary OEL - TWA 36 mg/m3
Ireland OEL - TWAs 10 ppm
36 mg/m3
Italy OEL - TWA 10 ppm
36 mg/m3
Latvia OEL - TWA 10 ppm
36 mg/m3
Lithuania OEL - TWA 10 ppm
36 mg/m3
Luxembourg OEL - TWA 10 ppm
36 mg/m3
Malta OEL - TWA 10 ppm
36 mg/m3
Netherlands OEL - TWA 36 mg/m3
OSHA - Final PELS - TWAs: 10 ppm
35 mg/m3
OSHA - Final PELs - Skin Notations: prevent or reduce skin absorption
Poland OEL - TWA 35 mg/m3
Portugal OEL - TWA 10 ppm
36 mg/m3
Romania OEL - TWA 10 ppm
36 mg/m3
Romania - Biological Exposure Limit: 30 µg/g Creatinine
Russia OEL - TWA 1 mg/m3

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8. EXPOSURE CONTROLS / PERSONAL PROTECTION

Slovakia OEL - TWA 10 ppm
36 mg/m3
Slovenia OEL - TWA 10 ppm
36 mg/m3
Spain OEL - TWA 10 ppm
36 mg/m3
Spain - Biological Exposure Limit: 30 mg/g Creatinine
Sweden OEL - TWAs 10 ppm
35 mg/m3
Switzerland OEL -TWAs 10 ppm
35 mg/m3
UK - Biological Exposure Limit: 100 mmol/mol creatinine

Polyethylene glycol
Austria OEL - MAKs 1000 mg/m3
Germany - TRGS 900 - TWAs 1000 mg/m3
Germany (DFG) - MAK 1000 mg/m3 average molecular weight 200-600
Slovakia OEL - TWA 1000 mg/m3
Slovenia OEL - TWA 1000 mg/m3
Switzerland OEL -TWAs 1000 mg/m3

Exposure Controls
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.
Personal Protective Refer to applicable national standards and regulations in the selection and use of personal
Equipment: protective equipment (PPE). Contact your safety and health professional or safety equipment
supplier for assistance in selecting the correct protective clothing/equipment based on an
assessment of the workplace conditions, other chemicals used or present in the workplace and
specific operational processes.

Hands: Impervious gloves (e.g. Nitrile, etc.) are recommended if skin contact with drug product is
possible and for bulk processing operations. (Protective gloves must meet the standards in
accordance with EN374, ASTM F1001 or international equivalent.)
Eyes: Wear safety glasses or goggles if eye contact is possible. (Eye protection must meet the
standards in accordance with EN166, ANSI Z87.1 or international equivalent.)
Skin: Impervious protective clothing is recommended if skin contact with drug product is possible and
for bulk processing operations. (Protective clothing must meet the standards in accordance
with EN13982, ANSI 103 or international equivalent.)
Respiratory protection: Under normal conditions of use, 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 (e.g. particulate respirator with a half mask, P3 filter). (Respirators must
meet the standards in accordance with EN140, EN143, ASTM F2704-10 or international
equivalent.)

9. PHYSICAL AND CHEMICAL PROPERTIES

Physical State: Solution Color: Clear, colorless

Odor: No data available. Odor Threshold: No data available.
Molecular Formula: Mixture Molecular Weight: Mixture

Solvent Solubility: No data available

Water Solubility: No data available
pH: No data available.
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9. PHYSICAL AND CHEMICAL PROPERTIES

Melting/Freezing Point (°C): No data available
Boiling Point (°C): No data available.
Partition Coefficient: (Method, pH, Endpoint, Value)
N,N-DIMETHYLACETAMIDE
No data available
Polyethylene glycol
No data available
Busulfan
No data available
Decomposition Temperature (°C): No data available.

Evaporation Rate (Gram/s): No data available

Vapor Pressure (kPa): No data available
Vapor Density (g/ml): No data available
Relative Density: No data available
Viscosity: No data available

Flammablity:
Autoignition Temperature (Solid) (°C): No data available
Flammability (Solids): No data available
Flash Point (Liquid) (°C): No data available
Upper Explosive Limits (Liquid) (% by Vol.): No data available
Lower Explosive Limits (Liquid) (% by Vol.): No data available

10. STABILITY AND REACTIVITY

Reactivity: No data available

Chemical Stability: Stable under normal conditions of use.
Possibility of Hazardous Reactions
Oxidizing Properties: No data available
Conditions to Avoid: Fine particles (such as mists) may fuel fires/explosions.
Incompatible Materials: As a precautionary measure, keep away from strong oxidizers
Hazardous Decomposition No data available
Products:

11. TOXICOLOGICAL INFORMATION

Information on Toxicological Effects

Known Clinical Effects: Common adverse effects include seizure myelosuppression, cardiac tamponade, pulmonary
dysfunction, fever, headache, loss of strength/exhaustion (prostration), increased heart rate
(tachycardia), increase in blood pressure (hypertension), nausea, inflammation of the mouth
(stomatitis), vomiting, loss of appetite (anorexia), insomnia, diarrhea, and anxiety. May cause
adverse effects on the developing fetus.

Acute Toxicity: (Species, Route, End Point, Dose)

N,N-DIMETHYLACETAMIDE
Rabbit Dermal LD 50 2240 mg/kg
Rat Inhalation LC50 1H 8.81 mg/L

Busulfan
Mouse Oral LD 50 120 mg/kg

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11. TOXICOLOGICAL INFORMATION

Irritation / Sensitization: (Study Type, Species, Severity)

Polyethylene glycol
Eye Irritation Rabbit Mild
Skin Irritation Rabbit Mild

Reproduction & Development Toxicity: (Duration, Species, Route, Dose, End Point, Effect(s))

Busulfan
Embryo / Fetal Development Rat Oral 48 mg/kg/day LOAEL Teratogenic, Early embryonic development
Reproductive & Fertility Rat Oral 49 mg/kg/day LOAEL Fertility
Embryo / Fetal Development Rabbit Oral 32 mg/kg/day LOAEL Teratogenic, Fetotoxicity, Early embryonic
development
Embryo / Fetal Development Mouse Oral 40 mg/kg/day LOAEL Teratogenic, Fetotoxicity, Early embryonic
development

Genetic Toxicity: (Study Type, Cell Type/Organism, Result)

Busulfan
In Vivo Chromosome Aberration Rat Positive
Bacterial Mutagenicity (Ames) Salmonella Positive
In Vivo Direct DNA Damage Rat Hepatocyte Positive
Sister Chromatid Exchange Human Lymphocytes Positive
Unscheduled DNA Synthesis Mouse Positive

Carcinogen Status: See below

Busulfan
IARC: Group 1 (Carcinogenic to Humans)
NTP: Known Human Carcinogen

12. ECOLOGICAL INFORMATION

Environmental Overview: Environmental properties have not been investigated.

Toxicity: No data available

Persistence and Degradability: No data available

Bio-accumulative Potential: No data available

Mobility in Soil: No data available

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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

Safety, Health and Environmental Regulations/Legislation Specific for the Substance or Mixture

Busulfan
CERCLA/SARA 313 Emission reporting Not Listed
California Proposition 65 carcinogen 2/27/1987
developmental toxicity 1/1/1989
Australia (AICS): Present
Standard for the Uniform Scheduling Schedule 4
for Drugs and Poisons:
EU EINECS/ELINCS List 200-250-2

N,N-DIMETHYLACETAMIDE
CERCLA/SARA 313 Emission reporting Not Listed
California Proposition 65 developmental toxicity 5/21/2010
male reproductive toxicity 5/21/10
Inventory - United States TSCA - Sect. 8(b) Present
Australia (AICS): Present
Standard for the Uniform Scheduling Schedule 5
for Drugs and Poisons: Schedule 6
REACH - Annex XVII - Restrictions on Certain Use restricted. See item 30.
Dangerous Substances:
REACH - Toxic to Reproduction Category 2: Present
EU EINECS/ELINCS List 204-826-4

Polyethylene glycol
CERCLA/SARA 313 Emission reporting Not Listed
California Proposition 65 Not Listed

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15. REGULATORY INFORMATION

Inventory - United States TSCA - Sect. 8(b) Present
Australia (AICS): Present
Standard for the Uniform Scheduling Schedule 2
for Drugs and Poisons: Schedule 3
EU EINECS/ELINCS List Not Listed

16. OTHER INFORMATION

Text of CLP/GHS Classification abbreviations mentioned in Section 3

Carcinogenicity-Cat.1B; H350 - May cause cancer

Germ cell mutagenicity-Cat.1B; H340 - May cause genetic defects
Reproductive toxicity-Cat.1B; H360FD - May damage fertility. May damage the unborn child.
Acute toxicity, dermal-Cat.4; H312 - Harmful in contact with skin
Acute toxicity, inhalation-Cat.4; H332 - Harmful if inhaled
Serious eye damage/eye irritation-Cat.2A; H319 - Causes serious eye irritation

Data Sources: Pfizer proprietary drug development information. Publicly available toxicity information.

Reasons for Revision: Updated Section 1 - Identification of the Substance/Preparation and the Company/Undertaking.
Updated Section 2 - Hazard Identification. Updated Section 7 - Handling and Storage.

Revision date: 25-Jan-2019

Product Stewardship Hazard Communication
Prepared by: Pfizer Global Environment, Health, and Safety Operations

Pfizer Inc believes that the information contained in this 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

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