MATERIAL SAFETY DATA SHEET
Revision date: 22-Sep-2009 Version: 1.4 Page 1 of 8
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING
Pfizer Inc Pfizer Ltd
Pfizer Pharmaceuticals Group Ramsgate Road
235 East 42nd Street Sandwich, Kent
New York, New York 10017 CT13 9NJ
1-212-573-2222 United Kingdom
+00 44 (0)1304 616161
Emergency telephone number: Emergency telephone number:
CHEMTREC (24 hours): 1-800-424-9300 ChemSafe (24 hours): +44 (0)208 762 8322
Contact E-Mail: pfizer-MSDS@pfizer.com
Material Name: Maraviroc Oral Solution
Trade Name: CELSENTRI; SELZENTRY
Chemical Family: Mixture
Intended Use: Pharmaceutical product for the treatment of HIV
2. HAZARDS IDENTIFICATION
Appearance: Liquid
Statement of Hazard: Non-hazardous in accordance with international standards for workplace safety.
Additional Hazard Information:
Short Term: May cause skin irritation. May cause eye irritation (based on components) .
Long Term: Repeat-dose studies in animals have shown a potential to cause adverse effects on
cardiovascular system.
Known Clinical Effects: Adverse effects most commonly reported in clinical use include diarrhea, headache, nausea,
vomiting, dizziness, insomnia and skin rash.
EU Indication of danger: Not classified
Australian Hazard Classification Non-Hazardous Substance. Non-Dangerous Goods.
(NOHSC):
Note: This document has been prepared in accordance with standards for workplace safety, which
require the inclusion of all known hazards of the product or its ingredients 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 Classification %
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3. COMPOSITION/INFORMATION ON INGREDIENTS
Maraviroc 376348-65-1 Not listed Xn; R48/22 2%
Citric acid, anhydrous 77-92-9 201-069-1 Not Listed *
Hydrochloric Acid 7647-01-0 231-595-7 C;R35 **
T;R23
Ingredient CAS Number EU EINECS/ELINCS List Classification %
Sodium citrate 68-04-2 200-675-3 Not Listed *
Sodium benzoate 532-32-1 208-534-8 Not Listed *
Sucralose 56038-13-2 259-952-2 Not Listed *
Flavoring NOT ASSIGNED Not listed Not Listed *
Water, purified 7732-18-5 231-791-2 Not Listed *
Additional Information: * Proprietary
** to adjust pH
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: Emits toxic fumes of oxides of nitrogen, carbon monoxide, carbon dioxide, and halogen-
containing gases.
Fire Fighting Procedures: During all fire fighting activities, wear appropriate protective equipment, including self-
contained breathing apparatus.
Fire / Explosion Hazards: Fine particles (such as dust and mists) may fuel fires/explosions.
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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 Place waste in an appropriately labeled, sealed container for disposal. Care should be taken
Protections: to avoid environmental release.
Additional Consideration for Large Non-essential personnel should be evacuated from affected area. Report emergency
Spills: 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.
Maraviroc
3
Pfizer OEL TWA-8 Hr: 80礸/m
Hydrochloric Acid
ACGIH Ceiling Threshold Limit: 2 ppm
Australia PEAK 5 ppm
3
7.5 mg/m
Austria OEL - MAKs Listed
Belgium OEL - TWA Listed
Bulgaria OEL - TWA Listed
Cyprus OEL - TWA Listed
Czech Republic OEL - TWA Listed
Estonia OEL - TWA Listed
Germany - TRGS 900 - TWAs 2 ppm
3
3 mg/m
Germany (DFG) - MAK 2 ppm MAK
3
3.0 mg/m MAK
Greece OEL - TWA Listed
Hungary OEL - TWA Listed
Ireland OEL - TWAs Listed
Italy OEL - TWA Listed
Japan - OELs - Ceilings 5 ppm
3
7.5 mg/m
Latvia OEL - TWA Listed
Lithuania OEL - TWA Listed
Luxembourg OEL - TWA Listed
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8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Malta OEL - TWA Listed
Netherlands OEL - TWA Listed
Poland OEL - TWA Listed
Romania OEL - TWA Listed
Slovenia OEL - TWA Listed
Spain OEL - TWA Listed
Analytical Method: Analytical method available for Maraviroc. 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.
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
Physical State: Color:
Liquid No data available.
Molecular Formula: Molecular Weight:
Mixture Mixture
pH: 3.8 +/-0.2
Polymerization: Will not occur
10. STABILITY AND REACTIVITY
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 individual
ingredients.
Acute Toxicity: (Species, Route, End Point, Dose)
Maraviroc
Rat Oral LD50 > 2000 mg/kg
Mouse Oral LD50 > 2000 mg/kg
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11. TOXICOLOGICAL INFORMATION
Citric acid, anhydrous
Rat Oral LD50 3000 mg/kg
Sodium benzoate
Rat Oral LD50 4,070 mg/kg
Mouse Oral LD50 1600 mg/kg
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)
Maraviroc
Eye Irritation Rabbit Minimal
Skin Irritation Rabbit Non-irritating
Skin Sensitization - LLNA Mouse Negative
Citric acid, anhydrous
Eye Irritation Rabbit Severe
Skin Irritation Rabbit Mild
Hydrochloric Acid
Skin Irritation Severe
Eye Irritation Severe
Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ)
Maraviroc
1 Month(s) Dog Oral 5 mg/kg/day NOAEL Cardiovascular system, Eyes, Heart
6 Month(s) Dog Oral 5 mg/kg/day NOAEL Cardiovascular system Heart Eyes
1 Month(s) Rat Oral 300 mg/kg/day NOAEL Liver Gastrointestinal system
6 Month(s) Rat Oral 100 mg/kg/day NOAEL Liver
9 Month(s) Monkey Oral 120 mg/kg/day NOAEL Cardiovascular system Heart
Sodium benzoate
10 Day(s) Rat Oral 27370 mg/kg LOAEL Liver, Blood
10 Day(s) Mouse Oral 45 g/kg LOAEL Liver Kidney Blood Ureter Bladder
Reproduction & Developmental Toxicity: (Study Type, Species, Route, Dose, End Point, Effect(s))
Maraviroc
Fertility and Embryonic Development Rat Oral 1000 mg/kg/day NOAEL Maternal toxicity, Embryotoxicity
Embryo / Fetal Development Rat Oral 300 (maternal) /1000 (fetal) mg/kg/day NOAEL No effects at maximum dose
Embryo / Fetal Development Rabbit Oral 75 (maternal)/ 200 (fetal) mg/kg/day NOAEL Maternal Toxicity
Peri-/Postnatal Development Rat Oral 300 mg/kg/day NOAEL Maternal Toxicity, Developmental toxicity
Sodium benzoate
Embryo / Fetal Development Rat Oral 44 g/kg LOEL Developmental toxicity
Genetic Toxicity: (Study Type, Cell Type/Organism, Result)
Maraviroc
In Vitro Bacterial Mutagenicity (Ames) Salmonella , E. coli Negative
In Vitro Chromosome Aberration Human Lymphocytes Negative
In Vivo Micronucleus Mouse Negative
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11. TOXICOLOGICAL INFORMATION
Carcinogenicity: (Duration, Species, Route, Dose, End Point, Effect(s))
Maraviroc
6 Month(s) Mouse Oral 1500 mg/kg/day NOAEL Not carcinogenic
104 Week(s) Rat Oral 900 mg/kg/day Not carcinogenic
Carcinogen Status: None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA.
Hydrochloric Acid
IARC: Group 3
12. ECOLOGICAL INFORMATION
Environmental Overview: Releases to the environment should be avoided. No harmful effects to aquatic organisms are
expected. No toxicity to wastewater treatment microorganisms is expected. This material has
low potential to bioaccumulate and long-term adverse effects to aquatic organisms are not
expected.
Aquatic Toxicity: (Species, Method, End Point, Duration, Result)
Maraviroc
Daphnia magna (Water Flea) OECD EC50 48 Hours 69 mg/L
Oncorhynchus mykiss (Rainbow Trout) OECD LC50 96 Hours > 73 mg/L
Pseudokirchneriella subcapitata (Green Alga) OECD EC50 72 Hours > 115 mg/L
Ceriodaphnia dubia (Daphnids) EPA EC50 7 Days > 92 mg/L
Aquatic Toxicity Comments: A greater than (>) symbol indicates that acute ecotoxicity was not observed at the maximum
solubility. Since the substance is insoluble in aqueous solutions above this concentration, an
acute ecotoxicity value (i.e. LC/EC50) is not achievable.
Bacterial Inhibition: (Species, Method, End Point, Duration, Result)
Maraviroc
Activated sludge OECD EC50 > 1000 mg/L
13. DISPOSAL CONSIDERATIONS
Disposal Procedures: 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
Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations.
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15. REGULATORY INFORMATION
EU Indication of danger: Not classified
OSHA Label:
Non-hazardous in accordance with international standards for workplace safety.
Canada - WHMIS: Classifications
WHMIS hazard class:
Class D, Division 2, Subdivision B
Citric acid, anhydrous
Inventory - United States TSCA - Sect. 8(b) Listed
Australia (AICS): Listed
EU EINECS/ELINCS List 201-069-1
Sodium citrate
Inventory - United States TSCA - Sect. 8(b) Listed
Australia (AICS): Listed
Standard for the Uniform Scheduling Schedule 5
for Drugs and Poisons: Schedule 6
EU EINECS/ELINCS List 200-675-3
Sodium benzoate
Inventory - United States TSCA - Sect. 8(b) Listed
Australia (AICS): Listed
EU EINECS/ELINCS List 208-534-8
Sucralose
Australia (AICS): Listed
EU EINECS/ELINCS List 259-952-2
Hydrochloric Acid
CERCLA/SARA 313 Emission reporting 1.0% de minimis concentration acid aerosols including mists,
vapors, gas, fog, and other airborne forms of any particle size
CERCLA/SARA Hazardous Substances 2270 kg final RQ
and their Reportable Quantities: 5000 lb final RQ
CERCLA/SARA - Section 302 Extremely Hazardous 500 lb TPQ gas only
TPQs
CERCLA/SARA - Section 302 Extremely Hazardous 5000 lb
Substances EPCRA RQs
Inventory - United States TSCA - Sect. 8(b) Listed
Australia (AICS): Listed
Standard for the Uniform Scheduling Schedule 5
for Drugs and Poisons: Schedule 6
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15. REGULATORY INFORMATION
EU EINECS/ELINCS List 231-595-7
Water, purified
Inventory - United States TSCA - Sect. 8(b) Listed
Australia (AICS): Listed
REACH - Annex IV - Exemptions from the Present
obligations of Register:
EU EINECS/ELINCS List 231-791-2
16. OTHER INFORMATION
Text of R phrases mentioned in Section 3
R23 - Toxic by inhalation.
R35 - Causes severe burns.
R48/22 - Harmful: danger of serious damage to health by prolonged exposure if swallowed.
Data Sources: Pfizer proprietary drug development information. Safety data sheets for individual ingredients.
Reasons for Revision: Updated Section 2 - Hazard Identification. Updated Section 3 - Composition / Information on
Ingredients.
Prepared by: Toxicology and 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
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