MATERIAL SAFETY DATA SHEET
Revision date: 13-Sep-2007 Version: 2.2 Page 1 of 9
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING
Pfizer Animal Health Pfizer Ltd,
Pfizer Inc Kent
235 East 42nd Street CT13 9NJ
New York, NY 10017 United Kingdom
Poison Control Center Phone: 1-866-531-8896 +00 44 (0)1304 616161
Technical Services Phone: 1-800-366-5288
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: Cefovecin Sodium for Injection
Trade Name: CONVENIA
Chemical Family: Mixture
Intended Use: Veterinary product used as antibiotic agent
Restrictions on Use: Not for human use
2. HAZARDS IDENTIFICATION
Appearance: Off-white to yellow freeze-dried powder
Signal Word: WARNING
Statement of Hazard: May cause allergic skin reaction.
Additional Hazard Information:
Short Term: May cause skin irritation. May cause eye irritation (based on components) .
Known Clinical Effects: Individuals who are sensitive to beta lactam antibiotics, both penicillins and cephalosporins,
may experience contact or systemic hypersensitivity and anaphylaxis upon exposure to this
drug. Additionally, kidney toxicity (nephrotoxicity) and Pseudomembranous colitis (manifested
by watery diarrhea, urge to defecate, abdominal cramps, low-grade fever, bloody stools, and
abdominal pain) may also occur.
EU Indication of danger: Irritant
EU Hazard Symbols:
EU Risk Phrases:
R43 - May cause sensitization by skin contact.
Australian Hazard Classification 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 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.
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3. COMPOSITION/INFORMATION ON INGREDIENTS
Hazardous
Ingredient CAS Number EU EINECS/ELINCS List Classification %
Cefovecin sodium 141195-77-9 Not listed Xi;R43 20
Sodium hydroxide 1310-73-2 215-185-5 C;R35 **
Hydrochloric Acid 7647-01-0 231-595-7 C;R35 **
T;R23
Citric acid monohydrate 5949-29-1 Not listed Not Listed *
Ingredient CAS Number EU EINECS/ELINCS List Classification %
Sodium citrate, dihydrate 6132-04-3 Not listed Not Listed *
Methylparaben 99-76-3 202-785-7 Not Listed *
Propylparaben 94-13-3 202-307-7 Not Listed *
Water for injection 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. Delayed effects may occur. For information on potential delayed effects, see
Section 2 - Hazards Identification and/or Section 11 - Toxicological Information.
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.
5. FIRE FIGHTING MEASURES
Extinguishing Media: Use carbon dioxide, dry chemical, or water spray.
Hazardous Combustion Products: No data available
Fire Fighting Procedures: During all fire fighting activities, wear appropriate protective equipment, including self-
contained breathing apparatus.
Fire / Explosion Hazards: No data available
6. ACCIDENTAL RELEASE MEASURES
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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 Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to
Protections: 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: 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 thoroughly after handling. Releases to the environment should be avoided.
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.
Cefovecin sodium
1000碌g/m3, Sensitizer
Pfizer OEL TWA-8 Hr:
Sodium hydroxide
= 2 mg/m3 Ceiling
ACGIH Ceiling Threshold Limit:
= 2 mg/m3 Peak
Australia PEAK
= 2 mg/m3 MAK
Austria OEL - MAKs
= 2 mg/m3 TWA
Belgium OEL - TWA
= 2.0 mg/m3 TWA
Bulgaria OEL - TWA
= 1 mg/m3 TWA
Czech Republic OEL - TWA
= 2 mg/m3 TWA
Finland OEL - TWA
= 2 mg/m3 VME
France OEL - TWA
= 2 mg/m3 TWA
Greece OEL - TWA
= 2 mg/m3 TWA
Hungary OEL - TWA
= 0.5 mg/m3 TWA
Latvia OEL - TWA
OSHA - Final PELS - TWAs: 2 mg/m鲁
= 0.5 mg/m3 NDS
Poland OEL - TWA
= 2 mg/m3 TWA
Slovakia OEL - TWA
= 2 mg/m3 TWA
Slovenia OEL - TWA
= 1 mg/m3 LLV
Sweden OEL - TWAs
Hydrochloric Acid
ACGIH Ceiling Threshold Limit: = 2 ppm Ceiling
Australia PEAK = 5 ppm Peak
= 7.5 mg/m3 Peak
Austria OEL - MAKs = 5 ppm MAK
= 8 mg/m3 MAK
Belgium OEL - TWA = 5 ppm TWA
= 8 mg/m3 TWA
= 8.0 mg/m3 TWA
Bulgaria OEL - TWA
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Cyprus OEL - TWA = 5.0 ppm TWA
= 8.0 mg/m3 TWA
= 8 mg/m3 TWA
Czech Republic OEL - TWA
Estonia OEL - TWA = 5 ppm TWA
= 8 mg/m3 TWA
Germany - TRGS 900 - TWAs = 2 ppm TWA
= 3 mg/m3 TWA
= 5 ppm TWA
Greece OEL - TWA
= 7 mg/m3 TWA
= 8 mg/m3 TWA
Hungary OEL - TWA
Ireland OEL - TWAs = 5 ppm TWA
= 7 mg/m3 TWA
Italy OEL - TWA = 5 ppm TWA
= 8 mg/m3 TWA
Latvia OEL - TWA = 5 ppm TWA
= 8 mg/m3 TWA
Lithuania OEL - TWA = 5 ppm IPRV
= 8 mg/m3 IPRV
Luxembourg OEL - TWA = 5 ppm TWA
= 8 mg/m3 TWA
Malta OEL - TWA = 5 ppm TWA
= 8 mg/m3 TWA
Netherlands OEL - TWA = 5 ppm MAC
= 8 mg/m3 MAC
= 5 mg/m3 NDS
Poland OEL - TWA
Romania OEL - TWA = 5 ppm TWA
= 8 mg/m3 TWA
Slovakia OEL - TWA = 5 ppm TWA
= 8.0 mg/m3 TWA
Slovenia OEL - TWA = 5 ppm TWA anhydrous
= 8 mg/m3 TWA anhydrous
Spain OEL - TWA = 5 ppm VLA-ED
= 7.6 mg/m3 VLA-ED
The exposure limit(s) listed for solid components are only relevant if dust may be generated.
Analytical Method: Analytical method available for Cefovecin. 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.
Personal Protective Equipment:
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:
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Physical State: Freeze-dried Color: Off-white to yellow
Molecular Formula: Mixture Molecular Weight: Mixture
pH: 6.2 - 7.5 (reconstituted)
10. STABILITY AND REACTIVITY
Stability: Stable under normal conditions of use.
Conditions to Avoid: No data available
Incompatible Materials: No data available
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)
Methylparaben
Mouse Oral LD50 > 8000 mg/kg
Rat Oral LD50 2280 mg/kg
Propylparaben
Mouse Oral LD 50 6332 mg/kg
Mouse Intraperitoneal LD 50 200 mg/kg
Sodium hydroxide
Mouse IP LD50 40 mg/kg
Cefovecin sodium
Rat Oral LD50 >2000 mg/kg
Rat Dermal LD50 >2000 mg/kg
Dog Oral Maximally Tolerated Dose 1000 mg/kg
Dog Subcutaneous Maximally Tolerated Dose >2000 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)
Citric acid monohydrate
Eye Irritation Rabbit Mild
Skin Irritation Rabbit Mild
Sodium hydroxide
Eye Irritation Rabbit Severe
Skin Irritation Rabbit Severe
Cefovecin sodium
Eye Irritation Rabbit Minimal
Skin Irritation Rabbit Non-irritating
Skin Sensitization - LLNA Mouse Positive
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Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ)
Propylparaben
3 Week(s) Rat Oral 27.1 g/kg LOAEL Endocrine system
4 Week(s) Rat Oral 347.2 mg/kg LOAEL Male reproductive system
Cefovecin sodium
5 Week(s) Dog Subcutaneous 60 mg/kg/day NOAEL No effects at maximum dose
5 Week(s) Cat Subcutaneous 60 mg/kg/day NOAEL No effects at maximum dose
16 Week(s) Dog Subcutaneous 40 mg/kg/day NOAEL No effects at maximum dose
16 Week(s) Cat Subcutaneous 40 mg/kg/day NOAEL Gastrointestinal system
Genetic Toxicity: (Study Type, Cell Type/Organism, Result)
Cefovecin sodium
Bacterial Mutagenicity (Ames) Salmonella , E. coli Negative
In Vivo Micronucleus Rat Bone Marrow Negative
Mammalian Cell Mutagenicity Mouse Lymphoma Equivocal without activation
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: The environmental characteristics of this material have not been fully evaluated. Releases to
the environment should be avoided. See Aquatic toxicity data of the active ingredient, below:
Aquatic Toxicity: (Species, Method, End Point, Duration, Result)
Cefovecin sodium
Daphnia magna (Water Flea) NPDES EC50 48 Hours > 1000 mg/L
Mysidopsis bahia (Mysid Shrimp) NPDES LC50 48 Hours 580 mg/L
Cyprinodon variegatus (Sheepshead Minnow) NPDES LC50 48 Hours 770 mg/L
Aquatic Toxicity Comments: A greater than symbol (>) indicates that aquatic toxicity was not observed at the maximum
dose tested.
Bacterial Inhibition: (Species, Method, End Point, Duration, Result)
Cefovecin sodium
Polytox Surrogate IC50 4 Hours 10.31 mg/L
Polytox Surrogate MIC 4 Hours 1.85 mg/L
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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.
14. TRANSPORT INFORMATION
Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations.
15. REGULATORY INFORMATION
EU Symbol: Xi
EU Indication of danger: Irritant
EU Risk Phrases:
R43 - May cause sensitization by skin contact.
EU Safety Phrases:
S24 - Avoid contact with skin.
S37 - Wear suitable gloves.
OSHA Label:
WARNING
May cause allergic skin reaction.
Canada - WHMIS: Classifications
WHMIS hazard class:
D2b toxic materials
Sodium citrate, dihydrate
Australia (AICS): Present
Standard for the Uniform Scheduling Schedule 5
for Drugs and Poisons: Schedule 6
Methylparaben
Inventory - United States TSCA - Sect. 8(b) Present
Australia (AICS): Present
EU EINECS/ELINCS List 202-785-7
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Propylparaben
Inventory - United States TSCA - Sect. 8(b) Present
Australia (AICS): Present
EU EINECS/ELINCS List 202-307-7
Sodium hydroxide
CERCLA/SARA Hazardous Substances = 1000 lb final RQ
and their Reportable Quantities: = 454 kg final RQ
Inventory - United States TSCA - Sect. 8(b) Present
Australia (AICS): Present
Standard for the Uniform Scheduling Schedule 5
for Drugs and Poisons: Schedule 6
EU EINECS/ELINCS List 215-185-5
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 EPCRA RQ gas only
Substances EPCRA RQs
Inventory - United States TSCA - Sect. 8(b) T
Australia (AICS): Present
Standard for the Uniform Scheduling Schedule 5
for Drugs and Poisons: Schedule 6
EU EINECS/ELINCS List 231-595-7
Water for injection
Inventory - United States TSCA - Sect. 8(b) Present
Australia (AICS): Present
REACH - Annex IV - Exemptions from the Present
obligations of Register:
EU EINECS/ELINCS List 231-791-2
Citric acid monohydrate
Australia (AICS): Present
16. OTHER INFORMATION
Text of R phrases mentioned in Section 3
R23 - Toxic by inhalation.
R35 - Causes severe burns.
R43 - May cause sensitization by skin contact.
Data Sources: Pfizer proprietary drug development information. Publicly available toxicity information.
Reasons for Revision: Updated Section 3 - Composition / Information on Ingredients. Updated Section 4 - First Aid
Measures. Updated Section 7 - Handling and Storage. Updated Section 12 - Ecological
Information.
Prepared by: Toxicology and Hazard Communication
Pfizer Global Environment, Health, and Safety
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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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