MATERIAL SAFETY DATA SHEET
Revision date: 25-Oct-2007 Version: 1.0 Page 1 of 5
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING
Pfizer Animal Health Pfizer Ltd
Pfizer Inc Ramsgate Road
235 East 42nd Street Sandwich, Kent
New York, NY 10017 CT13 9NJ
Poison Control Center Phone: 1-866-531-8896 United Kingdom
Technical Services Phone: 1-800-366-5288 +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: DEXDOMITOR
Trade Name: DEXDOMITOR
Chemical Family: Alpha2-adrenoreceptor agonist
Intended Use: Veterinary product used as sedative, analgesic
Restrictions on Use: Not for human use
2. HAZARDS IDENTIFICATION
Appearance: Clear, colorless solution
Statement of Hazard: Non-hazardous in accordance with international standards for workplace safety.
Additional Hazard Information:
Short Term: May be harmful if swallowed. May be harmful if absorbed through the skin. May cause central
nervous system effects. Inhalation of significant quantities of this substance could result in the
health effects described in 'Known clinical effects'.
Long Term: Repeat-dose studies in animals have shown a potential to cause adverse effects on eyes,
liver, thymus, endocrine system, and blood and blood forming organs.
Known Clinical Effects: May cause decrease in blood pressure (hypotension), sedation, slow breathing, fainting
(syncope), and decreased salivation.
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 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 %
Dexmedetomidine hydrochloride 145108-58-3 Not listed Not Listed 0.5
Ingredient CAS Number EU EINECS/ELINCS List Classification %
Methylparaben 99-76-3 202-785-7 Not Listed *
Propylparaben 94-13-3 202-307-7 Not Listed *
Additional Information: * Proprietary
Ingredient(s) indicated as hazardous have been assessed under standards for workplace
safety.
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 self-
contained breathing apparatus.
Fire / Explosion Hazards: Fine particles (such as dust and mists) may fuel fires/explosions.
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 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.
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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). Avoid accidental injection. Wash
thoroughly after handling.
Storage Conditions: Do not freeze. Keep out of reach of children.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
No Occupational Exposure Limit (OEL) or Short Term Exposure Limit (STEL) has been identified.
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.
Personal Protective Equipment:
Hands: Wear impervious gloves if skin contact is possible.
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: Under normal conditions of use, respiratory protection is not expected to be necessary.
Whenever air contamination (mist, vapor or odor) is generated, respiratory protection is
recommended as a precaution to minimize exposure.
9. PHYSICAL AND CHEMICAL PROPERTIES:
Physical State: Solution Color: Clear, colorless
Molecular Formula: Mixture Molecular Weight: Mixture
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)
Methylparaben
Mouse Oral LD50 > 8000 mg/kg
Rat Oral LD50 2280 mg/kg
Propylparaben
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Mouse Oral LD 50 6332 mg/kg
Mouse Intraperitoneal LD 50 200 mg/kg
Dexmedetomidine hydrochloride
Dog IV LD50 = 2 mg/kg
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
Dexmedetomidine hydrochloride
28 Day(s) Rat Intravenous Eyes, Adrenal gland, Lungs
28 Day(s) Rat Intramuscular Adrenal gland, Eyes, Lungs
28 Day(s) Dog Intravenous Liver, Central Nervous System
28 Day(s) Dog Intramuscular Liver, Central Nervous System
Genetic Toxicity: (Study Type, Cell Type/Organism, Result)
Dexmedetomidine hydrochloride
In Vitro Bacterial Mutagenicity (Ames) Salmonella , E. coli Negative
In Vitro Mammalian Cell Mutagenicity Mouse Lymphoma Negative
In Vitro Chromosome Aberration Human Lymphocytes Positive with activation Negative without activation
In Vivo Micronucleus Mouse Positive
Carcinogen Status: None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA.
12. ECOLOGICAL INFORMATION
Environmental Overview: Environmental properties have not been investigated. Releases to the environment should be
avoided.
13. DISPOSAL CONSIDERATIONS
Disposal Procedures: Incineration is the recommended method of disposal for this material. Observe all local and
national regulations when disposing of this material.
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:
None required
This product has been classified in accordance with the hazard criteria of the CPR and the MSDS contains all of the information
required by the CPR.
Methylparaben
Inventory - United States TSCA - Sect. 8(b) Present
Australia (AICS): Present
EU EINECS/ELINCS List 202-785-7
Propylparaben
Inventory - United States TSCA - Sect. 8(b) Present
Australia (AICS): Present
EU EINECS/ELINCS List 202-307-7
16. OTHER INFORMATION
Data Sources: Safety data sheets for individual ingredients. Publicly available toxicity information. Commercial
vendor MSDS.
Prepared by: Toxicology and Hazard Communication
Pfizer Global Environment, Health, and Safety
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 a warranty of any kind, expressed or implied.
End of Safety Data Sheet
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