Y:\wercs.ps

SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND THE
COMPANY/UNDERTAKING
Product Identifier
Material Name: VALBAZEN® (Albendazole) suspension
Trade Name:
Synonyms:
Albendazole suspension , VALBAZEN® SUSPENSION, Valbazen® Ultra, Valbazen® ForCattle Chemical Family:
Relevant Identified Uses of the Substance or Mixture and Uses Advised Against
Intended Use:
Veterinary product used as anti-worm agent (anthelmintic) Details of the Supplier of the Safety Data Sheet
Zoetis Inc.
Zoetis Belgium S.A.
100 Campus Drive, P.O. Box 651
Mercuriusstraat 20
Florham Park, New Jersey 07932 (USA)
1930 Zaventem
Rocky Mountain Poison Control Center Phone: 1-866-531-8896
Product Support/Technical Services Phone: 1-800-366-5288
Emergency telephone number:
Emergency telephone number:
CHEMTREC (24 hours): 1-800-424-9300
International CHEMTREC (24 hours): +1-703-527-3887
Contact E-Mail:
2. HAZARDS IDENTIFICATION
Appearance:
Classification of the Substance or Mixture
Reproductive Toxicity: Category 1BSpecific target organ systemic toxicity (repeated exposure): Category 2Acute aquatic toxicity: Category 1Chronic aquatic toxicity: Category 1 EU Classification:
EU Indication of danger: Toxic to reproduction, Category 2 R48/22 - Harmful: danger of serious damage to health by prolonged exposure if swallowed.
R61 - May cause harm to the unborn child.
R50/53 - Very toxic to aquatic organisms, may cause long-term adverse effects in the aquaticenvironment.
Label Elements
Signal Word:
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SAFETY DATA SHEET
Material Name: VALBAZEN® (Albendazole) suspension
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Revision date: 11-Oct-2013
Version: 3.0
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2. HAZARDS IDENTIFICATION
Hazard Statements:
H360D - May damage the unborn childH373 - May cause damage to organs through prolonged or repeated exposureH410 - Very toxic to aquatic life with long lasting effects Precautionary Statements:
P201 - Obtain special instructions before useP202 - Do not handle until all safety precautions have been read and understoodP280 - Wear protective gloves/protective clothing/eye protection/face protectionP260 - Do not breathe dust/fume/gas/mist/vapors/sprayP308 + P313 - IF exposed or concerned: Get medical attention/adviceP314 - Get medical attention/advice if you feel unwellP273 - Avoid release to the environmentP391 - Collect spillageP405 - Store locked upP501 - Dispose of contents/container in accordance with all local and national regulations Other Hazards
Short Term:
May cause eye and skin irritation (based on components) . May cause allergic skin reaction .
Long Term:
Repeat-dose studies in animals have shown a potential to cause adverse effects on testesand the developing fetus.
Known Clinical Effects:
Adverse effects seen in clinical use include gastrointestinal discomfort, dizziness, andheadache.
Australian Hazard Classification
Hazardous Substance. Dangerous Goods.
(NOHSC):
This document has been prepared in accordance with standards for workplace safety, whichrequire the inclusion of all known hazards of the product or its ingredients regardless of thepotential 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 Classification
EINECS/ELINCS
Classification
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SAFETY DATA SHEET
Material Name: VALBAZEN® (Albendazole) suspension
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Revision date: 11-Oct-2013
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Ingredient
CAS Number
EU Classification
EINECS/ELINCS
Classification
Additional Information:
Ingredient(s) indicated as hazardous have been assessed under standards for workplacesafety.
For the full text of the R phrases and CLP/GHS abbreviations mentioned in this Section, see Section 16
4. FIRST AID MEASURES
Description of First Aid Measures
Eye Contact:
Flush with water while holding eyelids open for at least 15 minutes. Seek medical attentionimmediately.
Skin Contact:
Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seekmedical attention.
Ingestion:
Never give anything by mouth to an unconscious person. Wash out mouth with water. Do notinduce vomiting unless directed by medical personnel. Seek medical attention immediately.
Inhalation:
Remove to fresh air and keep patient at rest. Seek medical attention immediately.
Most Important Symptoms and Effects, Both Acute and Delayed
Symptoms and Effects of
For information on potential signs and symptoms of exposure, See Section 2 - Hazards Exposure:
Identification and/or Section 11 - Toxicological Information.
Medical Conditions
Aggravated by Exposure:
Indication of the Immediate Medical Attention and Special Treatment Needed
Notes to Physician:
5. FIRE-FIGHTING MEASURES
Extinguishing Media:
Use water, carbon dioxide, foam or dry chemical extinguishers.
Special Hazards Arising from the Substance or Mixture
Hazardous Combustion
Formation of toxic gases is possible during heating or fire.
Products:
Fire / Explosion Hazards:
Fine particles (such as dust and mists) may fuel fires/explosions.
Advice for Fire-Fighters
Wear approved positive pressure, self-contained breathing apparatus and full protective turn out gear.
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SAFETY DATA SHEET
Material Name: VALBAZEN® (Albendazole) suspension
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Revision date: 11-Oct-2013
Version: 3.0
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6. ACCIDENTAL RELEASE MEASURES
Personal Precautions, Protective Equipment and Emergency Procedures
Personnel involved in clean-up should wear appropriate personal protective equipment (see Section 8). Minimize exposure.
Environmental Precautions
Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to avoid environmental release.
Methods and Material for Containment and Cleaning Up
Measures for Cleaning /
Contain the source of spill if it is safe to do so. Collect spill with absorbent material. Clean spill Collecting:
Additional Consideration for
Non-essential personnel should be evacuated from affected area. Report emergency Large Spills:
situations immediately. Clean up operations should only be undertaken by trained personnel.
7. HANDLING AND STORAGE
Precautions for Safe Handling
Use with adequate ventilation. Avoid breathing vapor or mist. Avoid contact with eyes, skin and clothing. When handling, useappropriate personal protective equipment (see Section 8). Releases to the environment should be avoided. Review andimplement appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure orenvironmental releases. Potential points of process emissions of this material to the atmosphere should be controlled with dustcollectors, HEPA filtration systems or other equivalent controls.
Conditions for Safe Storage, Including any Incompatibilities
Storage Conditions:
Store as directed by product packaging.
Specific end use(s):
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Control Parameters
Refer to available public information for specific member state Occupational Exposure Limits.
Albendazole
Zoetis OEL TWA 8-hr
Benzoic Acid
Latvia OEL - TWA
Glycerol
ACGIH Threshold Limit Value (TWA)
ACGIH OELs - Notice of Intended Changes
Australia TWA
Belgium OEL - 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
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SAFETY DATA SHEET
Material Name: VALBAZEN® (Albendazole) suspension
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Revision date: 11-Oct-2013
Version: 3.0
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8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Spain OEL - TWA
Switzerland OEL -TWAs
Exposure Controls
Engineering Controls:
Engineering controls should be used as the primary means to control exposures. Generalroom ventilation is adequate unless the process generates dust, mist or fumes. Keep airbornecontamination levels below the exposure limits listed above in this section.
Personal Protective
Refer to applicable national standards and regulations in the selection and use of personal Equipment:
Impervious gloves are recommended if skin contact with drug product is possible and for bulkprocessing operations.
Wear safety glasses or goggles if eye contact is possible.
Impervious protective clothing is recommended if skin contact with drug product is possible andfor bulk processing operations.
Respiratory protection:
If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriaterespirator with a protection factor sufficient to control exposures to below the OEL.
9. PHYSICAL AND CHEMICAL PROPERTIES
Physical State:
Odor Threshold:
Molecular Formula:
Molecular Weight:
Solvent Solubility:
Water solubility:
Water Solubility:
Melting/Freezing Point (°C):
Boiling Point (°C):
Partition Coefficient: (Method, pH, Endpoint, Value)
Albendazole
Predicted 7.4 Log D 3.06
Decomposition Temperature (°C):
Evaporation Rate (Gram/s):
Vapor Pressure (kPa):
Vapor Density (g/ml):
Relative Density:
Viscosity:
Flammablity:
Autoignition Temperature (Solid) (°C):
Flammability (Solids):
Flash Point (Liquid) (°C):
Upper Explosive Limits (Liquid) (% by Vol.):
Lower Explosive Limits (Liquid) (% by Vol.):
Polymerization:
10. STABILITY AND REACTIVITY
Reactivity:
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SAFETY DATA SHEET
Material Name: VALBAZEN® (Albendazole) suspension
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Revision date: 11-Oct-2013
Version: 3.0
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10. STABILITY AND REACTIVITY
Chemical Stability:
Stable under normal conditions of use.
Possibility of Hazardous Reactions
Oxidizing Properties:
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 Hazardous Decomposition
Thermal decomposition products may include carbon monoxide, carbon dioxide and other toxic Products:
11. TOXICOLOGICAL INFORMATION
Information on Toxicological Effects
General Information:
Toxicological properties of the formulation have not been investigated. The informationincluded in this section describes the potential hazards of the individual ingredients.
Acute Toxicity: (Species, Route, End Point, Dose)
Sorbitan monolaurate
Rat Oral LD 50 = 33600 mg/kg
Benzoic Acid
Rat Oral LD50 1700 mg/kg
Rat Oral LD50 2350 mg/kg
Carboxymethylcellulose sodium
Mouse Oral LD50 > 27,000 mg/kg
Rat Oral LD50 27,000 mg/kg
Rabbit Dermal LD50 > 2000 mg/kg
Polysorbate 80
Rat Oral LD50 25 g/kg
Potassium sorbate
Mouse Oral LD50 3800 mg/kg
Rat Oral LD50 4340 mg/kg
Albendazole
Mouse Oral LD50 > 3000 mg/kg
Rat Oral LD50 > 1320 mg/kg
Acute Toxicity Comments:
A greater than symbol (>) indicates that the toxicity endpoint being tested was not achievableat the highest dose used in the test.
Irritation / Sensitization: (Study Type, Species, Severity)
Benzoic Acid
Skin Irritation Rabbit Mild
Eye Irritation Rabbit Severe
Albendazole
Eye Irritation Rabbit Non-irritating
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SAFETY DATA SHEET
Material Name: VALBAZEN® (Albendazole) suspension
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Revision date: 11-Oct-2013
Version: 3.0
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11. TOXICOLOGICAL INFORMATION
Skin Irritation Rabbit Non-irritatingSkin Sensitization - Beuhler Guinea Pig Negative Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ)
Sorbitan monolaurate
13 Week(s) Rat Oral =112 g/kg LOAEL Liver, Kidney, Bladder, Ureter
Carboxymethylcellulose sodium
13 Week(s) Rat Oral 227 g/kg LOAEL Liver, Kidney, Ureter, Bladder
Albendazole
4 Week(s) Rat Oral 25 mg/kg/day NOAEL Adrenal gland, Blood forming organs, Male reproductive system, Spleen
3 Month(s) Rat Oral 30 mg/kg/day NOAEL No effects at maximum dose
90 Day(s) Mouse Oral 20 (M); 40 (F) mg/kg/day NOAEL Liver
4 Week(s) Dog Oral 4 mg/kg/day NOAEL Adrenal gland, Blood forming organs, Bone Marrow, Male reproductive system
6 Month(s) Dog Oral 5 mg/kg/day NOAEL Blood forming organs, Kidney, Liver, Female reproductive system, Male
reproductive system
Reproduction & Development Toxicity: (Duration, Species, Route, Dose, End Point, Effect(s))
Albendazole
Prenatal & Postnatal Development Rat Oral 6 mg/kg/day NOAEL Developmental toxicity
Prenatal & Postnatal Development Mouse Oral 30 mg/kg/day NOAEL No effects at maximum dose
Reproductive & Fertility Rat Oral 1 mg/kg/day NOAEL Negative
Prenatal & Postnatal Development Rabbit Oral 5 mg/kg/day NOAEL Developmental toxicity
Genetic Toxicity: (Study Type, Cell Type/Organism, Result)
Albendazole
Bacterial Mutagenicity (Ames) Salmonella Negative
In Vitro Chromosome Aberration Chinese Hamster Ovary (CHO) cells Negative
Cell Transformation Assay Mouse Negative
Carcinogenicity: (Duration, Species, Route, Dose, End Point, Effect(s))
Albendazole
25 Month(s) Mouse Oral 400 mg/kg/day NOAEL Not carcinogenic
28 Month(s) Rat Oral 20 mg/kg/day NOAEL Not carcinogenic
Carcinogen Status:
None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA.
Product Level Toxicity Data
Acute toxicity
Calculated
Acute Toxicity Estimate (ATE)>5000 mg/kg (oral) _______________________________________________________________________________________________________
SAFETY DATA SHEET
Material Name: VALBAZEN® (Albendazole) suspension
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Revision date: 11-Oct-2013
Version: 3.0
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12. ECOLOGICAL INFORMATION
Environmental Overview:
Environmental properties of the formulation have not been investigated. The followinginformation is available for the individual ingredients. Releases to the environment should beavoided. Not readily biodegradable.
Toxicity:
Aquatic Toxicity: (Species, Method, End Point, Duration, Result)
Albendazole
Daphnia magna (Water Flea) TAD 4.08 EC50 48 Hours 0.024 mg/L
Pseudokirchneriella subcapitata (Green Alga) OECD 201 EC50 72 Hours > 0.42 mg/L
Aquatic Toxicity Comments:
A greater than symbol (>) indicates that aquatic toxicity was not observed at the maximumdose tested.
Persistence and Degradability:
Albendazole Not Ready
Bio-accumulative Potential:
Albendazole
Predicted 7.4 Log D 3.06
Mobility in Soil:
13. DISPOSAL CONSIDERATIONS
Waste Treatment Methods:
Dispose of waste in accordance with all applicable laws and regulations. Member Statespecific and Community specific provisions must be considered. Considering the relevantknown environmental and human health hazards of the material, review and implementappropriate technical and procedural waste water and waste disposal measures to preventoccupational exposure and environmental release. It is recommended that waste minimizationbe practiced. The best available technology should be utilized to prevent environmentalreleases. This may include destructive techniques for waste and wastewater.
14. TRANSPORT INFORMATION
The following refers to all modes of transportation unless specified below.
UN number:
UN proper shipping name:
Environmentally hazardous substances, liquid, n.o.s. (contains Albendazole) Transport hazard class(es):
Packing group:
Environmental Hazard(s):
DOT Proper shipping name:
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SAFETY DATA SHEET
Material Name: VALBAZEN® (Albendazole) suspension
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Revision date: 11-Oct-2013
Version: 3.0
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15. REGULATORY INFORMATION
Safety, Health and Environmental Regulations/Legislation Specific for the Substance or Mixture
Canada - WHMIS: Classifications
WHMIS hazard class:
Class D, Division 2, Subdivision A
Class D, Division 2, Subdivision B
Albendazole
CERCLA/SARA 313 Emission reporting
California Proposition 65
Australia (AICS):
Standard for the Uniform Scheduling
for Drugs and Poisons:
EU EINECS/ELINCS List
Sorbitan monolaurate
CERCLA/SARA 313 Emission reporting
California Proposition 65
Inventory - United States TSCA - Sect. 8(b)
Australia (AICS):
EU EINECS/ELINCS List
Simethicone
CERCLA/SARA 313 Emission reporting
California Proposition 65
Australia (AICS):
EU EINECS/ELINCS List
Potassium sorbate
CERCLA/SARA 313 Emission reporting
California Proposition 65
Inventory - United States TSCA - Sect. 8(b)
EU EINECS/ELINCS List
Benzoic Acid
CERCLA/SARA 313 Emission reporting
CERCLA/SARA Hazardous Substances
and their Reportable Quantities:
California Proposition 65
Inventory - United States TSCA - Sect. 8(b)
Australia (AICS):
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SAFETY DATA SHEET
Material Name: VALBAZEN® (Albendazole) suspension
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Revision date: 11-Oct-2013
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15. REGULATORY INFORMATION
EU EINECS/ELINCS List
Carboxymethylcellulose sodium
CERCLA/SARA 313 Emission reporting
California Proposition 65
Inventory - United States TSCA - Sect. 8(b)
Australia (AICS):
EU EINECS/ELINCS List
Magnesium aluminum silicate
CERCLA/SARA 313 Emission reporting
California Proposition 65
Inventory - United States TSCA - Sect. 8(b)
Australia (AICS):
EU EINECS/ELINCS List
Glycerol
CERCLA/SARA 313 Emission reporting
California Proposition 65
Inventory - United States TSCA - Sect. 8(b)
Australia (AICS):
REACH - Annex V - Exemptions from the
Present if not chemically modified, except they meet the criteria for obligations of Register:
classification as dangerous according to Directive 67/548/EEC,except those only classified as flammable [R10], as a skin irritant[R38] or as an eye irritant [R36], except they are persistent,bioaccumulative, and toxic or very persistent and verybioaccumulative in accordance with the criteria set out in AnnexXIII, except they were identified in accordance with Article 59[1] atleast two years previously as substances giving rise to anequivalent level of concern EU EINECS/ELINCS List
Polysorbate 80
CERCLA/SARA 313 Emission reporting
California Proposition 65
Inventory - United States TSCA - Sect. 8(b)
Australia (AICS):
EU EINECS/ELINCS List
16. OTHER INFORMATION
Text of R phrases and GHS Classification abbreviations mentioned in Section 3
Specific target organ toxicity, repeated exposure-Cat.2; H373 - May cause damage to organs through prolonged or repeated exposureReproductive toxicity-Cat.1B; H360D - May damage the unborn childHazardous to the aquatic environment, acute toxicity-Cat.1; H400 - Very toxic to aquatic lifeHazardous to the aquatic environment, chronic toxicity-Cat.1; H410 - Very toxic to aquatic life with long lasting effects _______________________________________________________________________________________________________
SAFETY DATA SHEET
Material Name: VALBAZEN® (Albendazole) suspension
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Xn - HarmfulToxic to Reproduction: Category 2N - Dangerous for the environment R61 - May cause harm to the unborn child.
R48/22 - Harmful: danger of serious damage to health by prolonged exposure if swallowed.
R50/53 - Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
Data Sources:
The data contained in this MSDS may have been gathered from confidential internal sources,raw material suppliers, or from the published literature.
Reasons for Revision:
Updated Section 1 - Identification of the Substance/Preparation and the Company/Undertaking.
Updated Section 2 - Hazard Identification. Updated Section 8 - Exposure Controls / PersonalProtection. Updated Section 14 - Transport Information.
Prepared by:
Toxicology and Hazard Communication Zoetis Global Risk Management Zoetis Inc. believes that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, itis without warranty of any kind, expressed or implied. If data for a hazard are not included in this document there is no knowninformation at this time.
End of Safety Data Sheet
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Source: https://online.zoetis.com/US/EN/MSDS_PI/MSDS/Valbazen.pdf