Material Safety Data Sheet - Patterson Veterinary

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MATERIAL SAFETY DATA SHEET
Revision date: 06-Mar-2012 Version: 3.0 Page 1 of 7
11. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING
'Pfizet Animal Health
Pfizer Inc
235 East 42nd Street
New York, NY 10017
Pfizer Ltd
Ramsgate Road
Sandwich, Kent
CT139NJ
Poison Control Center Phone: 1-866-531-8896
Technical Services Phone: 1-800-366·5288
Emergency telephone number:
United Kingdom
+0044 (0)1304 616161
Emergency telephone number:
CHEMTREC (24 hours): 1·800·424·9300 International CHEMTREC (24 hours): +1·703·527·3887
Contact E·Mall: pfizer-MSDS@pfizer.com
Material Name: Pyrantel pamoate oral suspension
Trade Name:
Chemical Family:
Intended Use:
12. HAZARDS IDENTIFICATION
Appearance:
Statement of Hazard:
Short Term:
Long Term:
Known Clinical Effects:
EU Indication of danger:
Australian Hazard Classification
(NOHSC):
Note:
RFD Liquid Wormer; NEMEX; BANMINTH; STRONGID-T
Tetrahydropyrimidine
Veterinary product used as anti·worm agent (anthelmintic)
Yellow suspension
Non-hazardous in accordance with international standards for workplace safety.
May cause mild eye irritation. (based on components) .
Repeat-dose studies in animals have shown a potential to cause adverse effects on
gastrointestinal system, liver.
Ingestion of this material may cause effects similar to those seen in clinical use including
nausea, vomiting, abdominal cramps, anorexia, diarrhea, and constipation. Occasional,
transient changes reported in liver function tests, but no liver damage seen.
Not classified
Non-Hazardous Substance. Non-Dangerous Goods.
This document has been prepared in accordance with standards for workplace safety, wihich
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.
13. COMPOSITION/INFORMATION ON INGREDIENTS
Hazardous
Ingredient CAS Number EU EINECS/ELINCS List EU Classification '%
Lecithin 8002-43-5 232-307-2 Not Listed •
Maqnesium aluminum silicate 1327-43-1 215-478-8 Not Listed •
Pyrantel pamoate 22204-24-6 244-837-1 Not Listed 2.27
Glycerin, USP 56-81-5 200-289-5 Not Listed •
170
Obtained by Global Safety Management, Inc. (www.globalsafetynet.com)
MATERIAL SAFETY DATA SHEET
Material Name: pyrantel pamoate oral suspension
Revision date: 06·Mar-2012
Page 20f7
Version: 3.0
Ingredient
~odium benzoate
Sorbitol
Water. purified
Polysorbate 80
Additional Information:
@. FIRST AID MEASURES
Eye Contact:
Skin Contact:
Ingestion:
Inhalation:
CAS Number EU EINECS/ELINCS List EU Classification %
532-32-1 208-534-8 Not Listed •
6706-59-8 Not Listed Not Listed •
7732-18-5 231-791-2 Not Listed •
9005-65-6 Not Listed Not Listed ·
• Proprietary
Ingredient(s} indicated as hazardous have been assessed under standards for workplace
safety.
Flush with water while holding eyelids open for at least 15 minutes. Seek medical attention
immediately.
Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seek
medical attention.
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.
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.
15. 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 selfcontained breathing apparatus.
Fire / Explosion Hazards: Fine particles (such as dust and mists) may fuel fires/explosions.
Is. ACCIDENTAL RELEASE MEASURES
Health and Safety Precautions:
Measures for Cleaning / Collecting:
Measures for Environmental
Protections:
Additional Consideration faT Large
Spills:
170
Personnel involved in clean-up should wear appropriate personal protective equipment (see
Section 8). Minimize exposure.
Contain the source of spill if it is safe to do so. Collect spill with absorbent material. Clean spill
area thoroughly.
Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to
avoid environmental release.
Non-essential personnel should be evacuated from affected area. Report emergency
situations immediately. Clean up operations should only be undertaken by trained personnel.
Obtained by Global Safety Management, Inc. (www.globalsafetynet.com)
MATERIAL SAFETY DATA SHEET
Material Name: Pyrantel pamoate oral suspension
Revision date: 06·Mar·2012
Page 3 of 7
Version: 3.0
17. HANDLING AND STORAGE
General Handling:
Storage Conditions:
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.
Store as directed by product packaging.
18. EXPOSURE CONTROLS I PERSONAL PROTECTION
Refer to available public Information for specific member state Occupational Exposure Limits.
Pyrantel pamoate
Pfizer DEL TWA·8 Hr: 300~g1m'
Glycerin, USP
ACGIH Threshold Limit Value (TWA)
Australia TWA
10 mg/m'
10 mg/m'
10 mg/m'
10 mg/m'
10 mglm'
20 mglm'
10 mglm'
Belgium DEL· TWA
Czech Republic OEL • TWA
Estonia OEL • TWA
Finland OEL· TWA
France OEL • TWA
Germany (DFG) • MAK
Greece OEL • TWA
Ireland OEL • TWAs
OSHA· Final PELS· TWAs:
Poland OEL • TWA
Portugal OEL • TWA
Spain OEL • TWA
Analytical Method:
Engineering Controls:
Environmental Exposure Controls:
Personal Protective Equipment:
Hands:
Eyes:
Skin:
Respiratory protection:
170
50 mg/m' inhalable fraction
10 mg/m'
10 mg/m'
15 mg/m'
10 mglm'
10 mglm'
10 mglm'
Analytical method available for pyrantel pamoate. Contact Pfizer Inc for further information.
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.
Refer to specific Member State legislation for requirements under Community environmental
legislation.
Refer to applicable national standards and regulations in the selection and use of personal
protective eqUipment (PPE).
Impervious gloves are recommended if skin contact with drug product is possible and for bulk
processing operations.
Wear safety glasses or goggles if eye contact is possible.
Impervious protective clothing is recommended if skin contact with dnug product is possible and
for bulk processing operations.
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.
Obtained by Global Safety Management, Inc. (www.globalsafetynet.com)
MATERIAL SAFETY DATA SHEET
Material Name: pyrantel pamoate oral suspension
Revision date: 06-Mar-2012
19. PHYSICAL AND CHEMICAL PROPERTIES
Physical State:
Molecular Formula:
pH:
Polymerization:
Suspension
Mixture
4.5-6.0
110. STABILITY AND REACTIVITY
Will not occur
Chemical Stability: Stable under normal conditions 01 use.
Color:
Molecular Weight:
Conditions to Avoid:
Incompatible Materials:
Fine particles (such as dust and mists) may fuel fires/explosions.
As a precautionary measure, keep away from strong oxidizers
111. TOXICOLOGICAL INFORMATION
Yellow
Mixture
Page 4 017
Version: 3.0
Generallnlormation: The information included in this section describes the potential hazards of the individual
ingredients.
Acute Toxicity: (Species, Route, End POint, Dose)
Sodium benzoate
Rat Oral LD50 4,070 mg/kg
Mouse Oral LD50 1600 mg/kg
Glycerin, USP
Mouse Oral LD50 4090 mg/kg
Rat Oral LD50 12.6 g/kg
Rabbit Dermal LD50 > 10 g/kg
Rat Inhalation LC501hr > 570 mg/m'
Rat Dermal LD 50 >21.9 glkg
Polysorbate 80
Rat Oral LD50 25 g/kg
Lecithin
Rat Oral LD50 > 8 mllkg
Pyrantel pamoate
Mouse Oral LD50 > 24 g/kg
Rat Oral LD50 > 24 g/kg
Mouse Intraperitoneal LD50 620 mg/kg
Rat Intraperitoneal LD50 535 mg/kg
Acute Toxicity Comments: A greater than symbol (» indicates Ihat the toxicity endpoint being tested was not achievable
al the highest dose used in the test.
Irritation / Sensitization: (Study Type, Species, Severity)
Glycerin, USP
Eye Irritation Rabbit Mild
170
Obtained by Global Safety Management, Inc. (www.globalsafetynet.com)
MATERIAL SAFETY DATA SHEET
Material Name: Pyrantel pamoate oral suspension
Revision date: 06-Mar-2012
111. TOXICOLOGICAL INFORMATION
Repeated Dose Toxicity: (Duration, Species, Route, Dose, End POint, Target Organ)
Sodium benzoate
10 Day(s) Rat LOAEL Liver, Blood
10Day(s) Mouse
Oral
Oral
27370 mglkg
45 g/kg LOAEL Liver, Kidney, Blood, Ureter, Bladder
Pyrantel pamoate
1 Month(s) Rat Oral 500 mg/kg/day NOAEL None identified
1 Month(s) Dog Oral 50 mg/kg/day LOAEL Gastrointestinal system, Liver
13 Week(s) Rat Oral 300 mglkg/day NOAEL None identified
13 Week(s) Dog Oral 100 mglkg/day NOAEL Gastrointestinal system, Liver
Reproduction & Development Toxicity: (Duration, Species, Route, Dose, End Potnt, Effect(s))
Sodium benzoate
Embryo I Fetal Development Rat Oral 44 glkg LOEL Developmental toxicity
pyrantel pamoate
Reproductive & Fertility Rat Oral 250 mglkg NOAEL No effects at maximum dose
Prenatal & Postnatal Development Rat Oral 250 mg/kg NOAEL No effects at maximum dose
Embryo I Fetal Development Rat Oral 250 mg/kg NOAEL Not Teratogenic
Embryo I Fetal Development Rabbit Oral 250 mg/kg NOAEL Not Teratogenic
Genetic Toxicity: (Study Type, Cell Type/Organism, Result)
Pyrantel pamoate
Bacterial Mutagenicity (Ames) Salmonella Negative
Page 5 of7
Version: 3.0
Carcinogen Status: None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA
112. ECOLOGICAL INFORMATION
Environmental Overview: Environmental properties have not been thoroughly investigated. Releases to the environment
should be avoided.
Aquatic Toxicity: (Species, Method, End Point, Duration, Result)
Glycerin, USP
Oncorhynchus mykiss (Rainbow Trout)
Daphnia magna (Water Flea) EC50
Aquatic Toxicity Comments:
LD50 96 Hours 50 mglL
24 Hours >500 mglL
A greater than symbol (» indicates that aquatic toxicity was not observed at the maximum
dose tested.
113, DISPOSAL CONSIDERATIONS
Waste Treatment Methods:
170
Dispose of waste in accordance with ail 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 indude destructive techniques for waste and wastewater.
Obtained by Global Safety Management, Inc. (www.globalsafetynet.com)
MATERIAL SAFETY DATA SHEET
Material Name: Pyrantel pamoate oral suspension
Revision date: 06·Mar·2012
114. TRANSPORT INFORMATION
The following refers to all modes of transportation unless specified below.
Not regulated for transport under USDOT, EUADR, lATA, or IMDG regulations.
115. 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
Page 6 of 7
Version: 3.0
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.
Lecithin
Inventory. United States TSCA • Sect. alb)
Australia (AICS):
REACH· Annex IV • Exemptions from the
obligations of Register:
EU EINECS/ELINCS List
Sodium benzoate
Inventory· United States TSCA • Sect. alb)
Australia (AICS):
EU EINECS/ELINCS List
Magnesium aluminum silicate
Inventory. United States TSCA • Sect. 8(b)
Australia (AICS):
EU EINECS/ELINCS List
Pyrantel pamoate
Australia (AICS):
EU EINECS/ELINCS List
Water, purified
Inventory· United States TSCA • Sect. alb)
170
Present
Present
Present
232·307·2
Present
Present
208·534·8
Present
Present
215-478·8
Present
244·837·1
Present
Obtained by Global Safety Management, Inc. (www.globalsafetynet.com)
MATERIAL SAFETY DATA SHEET
Material Name: Pyrantel pamoate oral suspension
Revision date: 06·Mar-2012
115. REGULATORY INFORMATION
Australia (AICS):
REACH - Annex IV - Exemptions from the
obligations of Register:
EU EINECS/ELINCS List
Glycerin, USP
Inventory - United States TSCA - Sect. 8(b)
Australia (AICS):
REACH - Annex V - Exemptions from the
obligations of Register:
EU EINECS/ELINCS List
Polysorbate 80
Inventory - United States TSCA - Sect. 8(b)
Australia (AICS):
116. OTHER INFORMATION
Present
Present
231-791-2
Present
Present
Page 7 of 7
Version: 3.0
Present if not chemically modified. except they meet the criteria for
classification as dangerous according to Directive 67/548/EEC.
except those only classified as flammable [R10], as a skin irritant
[R38J or as an eye irritant [R36J. except they are perSistent.
bioaccumulative. and toxic or very persistent and very
bioaccumulative in acccrdance with the criteria set out in Annex
XIII. except they were identified in accordance with Article 59[1J at
least two years previously as substances giving rise to an
equivalent level of concern
200-289-5
Present
Present
Data Sources: Pfizer proprietary drug development information. Publicly available toxicity information. Safety
data sheets for individual ingredients.
Reasons for Revision:
Prepared by:
Updated Section 1 - Identification of the Substance/Preparation and the Company/Undertaking.
Updated Section 7 - Handling and Storage.
Product Stewardship 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
170
Obtained by Global Safety Management, Inc. (www.globalsafetynet.com)

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