Material Safety Data Sheet - QC Supply

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1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING
Material Name: EAZI-BREED CIDR (progesterone) Sheep Insert
Trade Name: EAZI-BREED CIDR Sheep Insert
Synonyms: CIDR Sheep Insert; CIDR 330 Insert
Chemical Family: Mixture
Intended Use: Veterinary product used for estrus synchronization
2. HAZARDS IDENTIFICATION
Appearance: Solid
Signal Word: DANGER
Statement of Hazard: May cause cancer.
May damage fertility or the unborn child
Additional Hazard Information:
Long Term: Repeat-dose studies in animals have shown a potential to cause adverse effects on the
developing fetus.
Known Clinical Effects: Based on human experience, possible adverse effects following exposure to this compound
may include menstrual irregularities weight changes fluid retention drowsiness, sleepiness,
dizziness, sedation, and gastrointestinal disturbance.
EU Indication of danger: Carcinogenic: Category 2
Toxic to Reproduction: Category 2
EU Hazard Symbols:
EU Risk Phrases:
R45 - May cause cancer.
R60 - May impair fertility.
R61 - May cause harm to the unborn child.
Australian Hazard Classification
(NOHSC):
Hazardous Substance. Non-Dangerous Goods.
_______________________________________________________________________________________________________
PZ01000
Pfizer Ltd,
Kent
CT13 9NJ
United Kingdom
+00 44 (0)1304 616161
Emergency telephone number:
CHEMTREC (24 hours): 1-800-424-9300
Revision date: 19-May-2009
Emergency telephone number:
ChemSafe (24 hours): +44 (0)208 762 8322
Contact E-Mail: pfizer-MSDS@pfizer.com
Version: 1.1
MATERIAL SAFETY DATA SHEET
Page 1 of 6
Pfizer Animal Health
Pfizer Inc
235 East 42nd Street
New York, NY 10017
Poison Control Center Phone: 1-866-531-8896
Technical Services Phone: 1-800-366-5288
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 Classification %
Progesterone 57-83-0 200-350-6 Repr.Cat.2;R60-61
Carc.Cat.2;R45
0.30 gm/insert
Ingredient CAS Number EU EINECS/ELINCS List Classification %
Silicone rubber 63394-02-5 Not listed Not Listed %
Nylon 66 32131-17-2 Not listed 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: Not available
Fire Fighting Procedures: During all fire fighting activities, wear appropriate protective equipment, including selfcontained breathing apparatus.
Fire / Explosion Hazards: Not applicable
_______________________________________________________________________________________________________
PZ01000
Revision date: 19-May-2009
Material Name: EAZI-BREED CIDR (progesterone) Sheep
Insert
Version: 1.1
Page 2 of 6
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 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
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: Minimize dust generation and accumulation. Avoid inhalation and contact with skin, eye, 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.
Storage Conditions: Store as directed by product packaging.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
The exposure limit(s) listed for solid components are only relevant if dust or mist may be generated.
Analytical Method: Analytical method available for Progesterone. 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.
_______________________________________________________________________________________________________
PZ01000
Revision date: 19-May-2009
Material Name: EAZI-BREED CIDR (progesterone) Sheep
Insert
Version: 1.1
Progesterone
Page 3 of 6
Pfizer OEL TWA-8 Hr: 30 µg/m3
MATERIAL SAFETY DATA SHEET
_______________________________________________________________________________________________________
9. PHYSICAL AND CHEMICAL PROPERTIES
10. STABILITY AND REACTIVITY
Stability: Stable under normal conditions of use.
Conditions to Avoid: None known
Incompatible Materials: None known
11. TOXICOLOGICAL INFORMATION
General Information: The information included in this section describes the potential hazards of the active
ingredient(s).
Acute Toxicity: (Species, Route, End Point, Dose)
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.
Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ)
Reproduction & Development Toxicity: (Duration, Species, Route, Dose, End Point, Effect(s))
Genetic Toxicity: (Study Type, Cell Type/Organism, Result)
Carcinogenicity: (Duration, Species, Route, Dose, End Point, Effect(s))
_______________________________________________________________________________________________________
PZ01000
Progesterone
Reproductive & Fertility Rabbit No route specified Dose not specified Embryotoxicity
Molecular Weight: Mixture
Embryo / Fetal Development Rat No route specified Dose not specified Not Teratogenic
Rat Oral LD 50 >5000 mg/kg
Embryo / Fetal Development Monkey No route specified Dose not specified Not Teratogenic
Page 4 of 6
Rat Intraperitoneal LD 50 327 mg/kg
Progesterone
Bacterial Mutagenicity (Ames) Negative
Physical State:
In Vivo Dominant Lethal Assay Mouse Negative
Solid
Revision date: 19-May-2009
In Vivo Chromosome Aberration Rat Negative
Progesterone
In Vitro Chromosome Aberration Human Negative
Color:
In Vitro Cell Transformation Assay Rat Positive
No data available.
2 Year(s) Rabbit Intramuscular 13 mg/kg LOEL Female reproductive system
Material Name: EAZI-BREED CIDR (progesterone) Sheep
Insert
Progesterone
74 Week(s) Dog Subcutaneous 0.08-22.5 mg/day (increased dose) LOEL Female reproductive system
Molecular Formula: Mixture
Version: 1.1
Progesterone
MATERIAL SAFETY DATA SHEET
_______________________________________________________________________________________________________
11. TOXICOLOGICAL INFORMATION
Carcinogen Status: See below
12. ECOLOGICAL INFORMATION
Environmental Overview: Environmental properties have not been investigated. Releases to the environment should be
avoided.
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.
15. REGULATORY INFORMATION
EU Symbol: T
EU Indication of danger: Carcinogenic: Category 2
Toxic to Reproduction: Category 2
EU Risk Phrases:
R45 - May cause cancer.
R60 - May impair fertility.
R61 - May cause harm to the unborn child.
EU Safety Phrases:
S36/37 - Wear suitable protective clothing and gloves.
S53 - Avoid exposure - obtain special instructions before use.
_______________________________________________________________________________________________________
PZ01000
Revision date: 19-May-2009
IARC: Group 2B
40 Week(s) Rat Subcutaneous 200 mg/kg/day LOEL Malignant tumors, Liver
NTP: Listed
Material Name: EAZI-BREED CIDR (progesterone) Sheep
Insert
OSHA: Present
19 Week(s) Female Mouse Subcutaneous 25 mg/kg (5 days/week) LOEL Tumors, Mammary gland
Version: 1.1
Page 5 of 6
2 Year(s) Rabbit Intramuscular 13 mg/kg NOEL Not carcinogenic
18 Month(s) Mouse Subcutaneous 0.059 mg/day LOEL Malignant tumors, Female reproductive system, Mammary
gland
Progesterone
MATERIAL SAFETY DATA SHEET
_______________________________________________________________________________________________________
15. REGULATORY INFORMATION
OSHA Label:
DANGER
May cause cancer.
May damage fertility or the unborn child
Canada - WHMIS: Classifications
WHMIS hazard class:
Class D, Division 2, Subdivision A
16. OTHER INFORMATION
Text of R phrases mentioned in Section 3
R45 - May cause cancer.
R60 - May impair fertility.
R61 - May cause harm to the unborn child.
Data Sources: Pfizer proprietary drug development information. Publicly available toxicity information. Safety
data sheets for individual ingredients. Commercial vendor MSDS.
Reasons for Revision: Updated Section 1 - Identification of the Substance/Preparation and the Company/Undertaking.
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
_______________________________________________________________________________________________________
PZ01000
Australia (AICS): Listed
Australia (AICS): Listed
Revision date: 19-May-2009
Material Name: EAZI-BREED CIDR (progesterone) Sheep
Insert
Standard for the Uniform Scheduling
for Drugs and Poisons:
Schedule 4
Schedule 5
Progesterone
EU EINECS/ELINCS List 200-350-6
Version: 1.1
Silicone rubber
California Proposition 65
Australia (AICS): Listed
carcinogen, initial date 1/1/88
Nylon 66
Page 6 of 6
Inventory - United States TSCA - Sect. 8(b) Listed
Inventory - United States TSCA - Sect. 8(b) Listed

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