Version: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND THE COMPANY/UNDERTAKING Product Identifier Material Name: Bovatec 2.2
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1 Page 1 of IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND THE COMPANY/UNDERTAKING Product Identifier Trade Name: Chemical Family: BOVATEC Mixture Relevant Identified Uses of the Substance or Mixture and Uses Advised Against Intended Use: Veterinary product Details of the Supplier of the Safety Data Sheet Zoetis Inc. 100 Campus Drive, P.O. Box 651 Florham Park, New Jersey (USA) Rocky Mountain Poison Control Center Phone: Product Support/Technical Services Phone: Emergency telephone number: CHEMTREC (24 hours): Contact VMIPSrecords@zoetis.com Zoetis Belgium S.A. Mercuriusstraat Zaventem Belgium Emergency telephone number: International CHEMTREC (24 hours): Appearance: Light red solid Classification of the Substance or Mixture GHS - Classification Reproductive Toxicity: Category 1B Acute aquatic toxicity: Category 3 Chronic aquatic toxicity: Category 3 2. HAZARDS IDENTIFICATION US OSHA Specific - Classification Physical Hazard: Combustible Dust EU Classification: EU Indication of danger: Toxic to Reproduction: Category 2 EU Symbol: Label Elements Signal Word: Hazard Statements: T R52/53 - Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment. Danger H360 - May damage fertility or the unborn child H412 - Harmful to aquatic life with long lasting effects May form combustible dust concentrations in air
2 Page 2 of 10 Precautionary Statements: P201 - Obtain special instructions before use P202 - Do not handle until all safety precautions have been read and understood P210 - Keep away from heat/sparks/open flames/hot surfaces. - No smoking P273 - Avoid release to the environment P280 - Wear protective gloves/protective clothing/eye protection/face protection P308 + P313 - IF exposed or concerned: Get medical attention/advice P405 - Store locked up P501 - Dispose of contents/container in accordance with all local and national regulations Other Hazards Short Term: Australian Hazard Classification (NOHSC): Note: May produce slight eye irritation. May cause slight skin irritation. May be harmful if swallowed. May cause irritation of respiratory tract. Hazardous Substance. Non-Dangerous Goods. This document has been prepared in accordance with standards for workplace safety, which requires the inclusion of all known hazards of the product or its ingredients regardless of the potential risk. The precautionary statements and warning 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 EU Classification GHS Classification Zinc oxide N; R50-53 Aquatic Chronic 1 (H410) Aquatic Acute 1 (H400) T;R25 Xn;R21 Xn;R20 Xi;R36 Repro. Cat. 2;R61 N;R51/53 Acute Tox. Cat. 3 (H301) Acute Tox. Cat. 4 (H312) Acute Tox. Cat. 4 (H332) Eye Irrit. Cat. 2B (H320) Repro. Cat. 1B (H360) Aq. Acute Cat. 2 (H401) Aq. Chronic Cat.2 (H411) %
3 Page 3 of COMPOSITION/INFORMATION ON INGREDIENTS DICOPPER OXIDE Xn; R22 N; R50-53 Acute Tox. 4 (H302) Aquatic Chronic 1 (H410) Aquatic Acute 1 (H400) Additional Information: Ingredient(s) indicated as hazardous have been assessed under standards for workplace safety. For the full text of the R phrases and CLP/GHS abbreviations mentioned in this Section, see Section FIRST AID MEASURES Description of First Aid Measures Eye Contact: Skin Contact: Ingestion: Inhalation: Flush eye(s) immediately with plenty of water. If irritation occurs or persists, get medical attention. 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. 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 None known Aggravated by Exposure: Indication of the Immediate Medical Attention and Special Treatment Needed Notes to Physician: None 5. FIRE-FIGHTING MEASURES Extinguishing Media: Extinguish fires with CO2, extinguishing powder, foam, or water. Special Hazards Arising from the Substance or Mixture Hazardous Combustion Formation of toxic gases is possible during heating or fire. Products: Fire / Explosion Hazards: Dust can form an explosive mixture in air. Fine particles (such as dust and mists) may fuel fires/explosions. Advice for Fire-Fighters During all fire fighting activities, wear appropriate protective equipment, including self-contained breathing apparatus. 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. Avoid dust formation.
4 Page 4 of 10 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 / Eliminate possible ignition sources (e.g., heat, sparks, flame, impact, friction, electricity), and Collecting: follow appropriate grounding procedures. Contain the source of the spill if it is safe to do so. Collect spilled material by a method that controls dust generation. Use non-combustible absorbent material to wipe up spill and place in a sealed container for disposal. 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 Precautions for Safe Handling Eliminate possible ignition sources (e.g., heat, sparks, flame, impact, friction, electricity), and follow appropriate grounding and bonding procedures. Avoid contact with eyes, skin and clothing. Avoid breathing dust. Minimize dust generation and accumulation. Use with adequate ventilation. 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. Conditions for Safe Storage, Including any Incompatibilities Storage Conditions: Keep tightly closed in a dry, cool and well-ventilated place. Keep away from heat, sparks, flame, and other sources of ignition. Specific end use(s): 8. EXPOSURE CONTROLS / PERSONAL PROTECTION Control Parameters Refer to available public information for specific member state Occupational Exposure Limits. Zinc oxide ACGIH Threshold Limit Value (TWA) 2 mg/m 3 ACGIH Threshold Limit Value (STEL) 10 mg/m 3 Australia STEL 10 mg/m 3 Australia TWA 10 mg/m 3 5 mg/m 3 Austria OEL - MAKs 5 mg/m 3 Belgium OEL - TWA 10 mg/m 3 5 mg/m 3 Bulgaria OEL - TWA 5.0 mg/m 3 Czech Republic OEL - TWA 2 mg/m 3 Denmark OEL - TWA 4 mg/m 3 Estonia OEL - TWA 5 mg/m 3 Finland OEL - TWA 2 mg/m 3 France OEL - TWA 5 mg/m 3 10 mg/m 3 Germany (DFG) - MAK 1 mg/m 3 Greece OEL - TWA 5 mg/m 3 Hungary OEL - TWA 5 mg/m 3 Ireland OEL - TWAs 2 mg/m 3 Latvia OEL - TWA 0.5 mg/m 3
5 Page 5 of EXPOSURE CONTROLS / PERSONAL PROTECTION Lithuania OEL - TWA 5 mg/m 3 Vietnam OEL - TWAs 5 mg/m 3 OSHA - Final PELS - TWAs: 5 mg/m 3 15 mg/m 3 Poland OEL - TWA 5 mg/m 3 Portugal OEL - TWA 2 mg/m 3 Romania OEL - TWA 5 mg/m 3 Slovakia OEL - TWA 1 mg/m 3 Slovenia OEL - TWA 5 mg/m 3 Spain OEL - TWA 2 mg/m 3 Sweden OEL - TWAs 5 mg/m 3 Switzerland OEL -TWAs 3 mg/m 3 DICOPPER OXIDE ACGIH Threshold Limit Value (TWA) 1 mg/m 3 Finland OEL - TWA 1 mg/m 3 The purpose of the Occupational Exposure Band (OEB) classification system is to separate substances into different Hazard categories when the available data are sufficient to do so, but inadequate to establish an Occupational Exposure Limit (OEL). The OEB given is based upon an analysis of all currently available data; as such, this value may be subject to revision when new information becomes available. Zoetis OEB OEB 3 (control exposure to the range of 10ug/m 3 to < 100ug/m 3 ) Exposure Controls Engineering Controls: Personal Protective Equipment: Hands: Eyes: Skin: Respiratory protection: 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 air contamination levels below the exposure limits or within the OEB range listed above in this section. 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 drug product is possible and for bulk processing operations. If airborne exposures are within or exceed the Occupational Exposure Band (OEB) range, wear an appropriate respirator with a protection factor sufficient to control exposures to the bottom of the OEB range. 9. PHYSICAL AND CHEMICAL PROPERTIES Physical State: Solid Color: Light red Odor:. Odor Threshold:. Molecular Formula: Mixture Molecular Weight: Mixture Solvent Solubility: Water Solubility: Soluble ph:. Melting/Freezing Point ( C): Boiling Point ( C):.
6 Page 6 of 10 Partition Coefficient: (Method, ph, Endpoint, Value) Measured 7 Log P 2.3 Decomposition Temperature ( C):. 9. PHYSICAL AND CHEMICAL PROPERTIES 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.): 10. STABILITY AND REACTIVITY Reactivity: Chemical Stability: Possibility of Hazardous Reactions Oxidizing Properties: Conditions to Avoid: Incompatible Materials: Hazardous Decomposition Products: Stable under normal conditions of use. None Keep away from heat, spark, flames and all other sources of ignition. As a precautionary measure, keep away from strong oxidizers Thermal decomposition products may include carbon monoxide and carbon dioxide 11. TOXICOLOGICAL INFORMATION Information on Toxicological Effects General Information: The information included in this section describes the potential hazards of the individual ingredients. Acute Toxicity: (Species, Route, End Point, Dose) Zinc oxide Mouse Oral LD mg/kg Rat IP LD50 240mg/kg Mouse Inhalation LD mg/m 3 Rat Oral LD 50 >5000mg/kg DICOPPER OXIDE Rat Oral LD mg/kg Rat Dermal LD50 > 2000mg/kg Mouse Oral LD mg/kg Rat Oral LD mg/kg Rabbit Dermal LD mg/kg Rat Inhalation LC50/4h 2.65 mg/l
7 Page 7 of 10 Acute Toxicity Comments: 11. TOXICOLOGICAL INFORMATION 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) Zinc oxide Eye Irritation Rabbit Mild Skin Irritation Rabbit Mild Eye Irritation Rabbit Irritant Skin Irritation Rabbit Non-irritating Skin Sensitization - GPMT Guinea Pig Negative Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ) 13 Week(s) Rat Oral 1 mg/kg/day NOEL Blood forming organs 13 Week(s) Dog Oral 2 mg/kg/day NOEL Liver Reproduction & Development Toxicity: (Duration, Species, Route, Dose, End Point, Effect(s)) Embryo / Fetal Development Rabbit Oral 0.5 mg/kg/day NOEL Fetotoxicity, Maternal toxicity Embryo / Fetal Development Rat Oral 3 mg/kg/day NOEL Maternal Toxicity Prenatal & Postnatal Development Rat Oral 0.5 mg/kg/day NOAEL Embryotoxicity Genetic Toxicity: (Study Type, Cell Type/Organism, Result) In Vitro Bacterial Mutagenicity (Ames) Salmonella, E. coli Negative In Vitro Mitotic Gene Conversion Saccharomyces cerevisiae Negative In Vitro Mammalian Cell Mutagenicity Hamster Lung Cells Negative Unscheduled DNA Synthesis Rat Hepatocyte Negative Chromosome Aberration Fungi Human Lymphocytes Negative Carcinogenicity: (Duration, Species, Route, Dose, End Point, Effect(s)) 2 Year(s) Rat Oral 10 mg/kg/day NOEL Not carcinogenic 2 Year(s) Mouse Oral 120 mg/kg/day NOAEL Not carcinogenic Carcinogen Status: Product Level Toxicity Data Acute Toxicity Estimate (ATE) Oral calculated: Acute Toxicity Estimate (ATE) Dermal calculated: Acute Toxicity Estimate (ATE) Inhalation calculated: None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA mg/kg mg/kg mg/l
8 Page 8 of ECOLOGICAL INFORMATION Environmental Overview: Environmental properties have not been thoroughly investigated. Harmful to aquatic life with long lasting effects. Toxicity: Aquatic Toxicity: (Species, Method, End Point, Duration, Result) Zinc oxide Tadpole EC50 48 Hours 3.2 mg/l Daphnia magna (Water Flea) OECD EC50 48 Hours 5.4 mg/l Brachydanio rerio (Zebra fish) OECD LC50 96 Hours 2.5 mg/l Activated sludge OECD EC50 3 Hours > 1000 mg/l Scenedesmus subspicatus (Green Alga) OECD EC50 72 Hours 2.0 mg/l Terrestrial Toxicity: (Species, Method, End Point, Duration, Result) Eisenia foetida (Earthworm) OECD NOEC 28 Days 82.4 mg/kg Persistence and Degradability: Bio-accumulative Potential: Measured 7 Log P 2.3 Mobility in Soil: 13. DISPOSAL CONSIDERATIONS Waste Treatment Methods: 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 The following refers to all modes of transportation unless specified below. Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations.
9 Page 9 of 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 Zinc oxide CERCLA/SARA 313 Emission reporting California Proposition 65 Inventory - United States TSCA - Sect. 8(b) Present Australia (AICS): Present EU EINECS/ELINCS List CERCLA/SARA 313 Emission reporting California Proposition 65 Australia (AICS): Present EU EINECS/ELINCS List DICOPPER OXIDE CERCLA/SARA 313 Emission reporting California Proposition 65 Inventory - United States TSCA - Sect. 8(b) Present Australia (AICS): Present EU EINECS/ELINCS List OTHER INFORMATION Text of R phrases and GHS Classification abbreviations mentioned in Section 3 Acute toxicity, oral-cat.3; H301 - Toxic if swallowed Acute toxicity, oral-cat.4; H302 - Harmful if swallowed Acute toxicity, dermal-cat.4; H312 - Harmful in contact with skin Acute toxicity, inhalation-cat.4; H332 - Harmful if inhaled Serious eye damage/eye irritation-cat. 2B; H320 - Causes eye irritation Reproductive toxicity-cat.1b; H360 - May damage fertility or the unborn child Hazardous to the aquatic environment, acute toxicity-cat.1; H400 - Very toxic to aquatic life Hazardous to the aquatic environment, acute toxicity-cat.2; H401 - Toxic to aquatic life Hazardous to the aquatic environment, chronic toxicity-cat.1; H410 - Very toxic to aquatic life with long lasting effects Hazardous to the aquatic environment, chronic toxicity-cat.2; H411 - Toxic to aquatic life with long lasting effects
10 Page 10 of 10 T - Toxic Xi - Irritant N - Dangerous for the environment Xn - Harmful Toxic to Reproduction: Category 2 R20 - Harmful by inhalation. R21 - Harmful in contact with skin. R22 - Harmful if swallowed. R25 - Toxic if swallowed. R36 - Irritating to eyes. R61 - May cause harm to the unborn child. R50/53 - Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. R51/53 - Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. Data Sources: Reasons for Revision: The data contained in this MSDS may have been gathered from confidential internal sources, raw material suppliers, or from the published literature. Updated Section 1 - Identification of the Substance/Preparation and the Company/Undertaking. Updated Section 2 - Hazard Identification. Updated Section 3 - Composition / Information on Ingredients. Updated Section 6 - Accidental Release Measures. Updated Section 7 - Handling and Storage. Updated Section 8 - Exposure Controls / Personal Protection. Updated Section 11 - Toxicology Information. Updated Section 12 - Ecological Information. Updated Section 15 - Regulatory Information. Prepared by: Toxicology and Hazard Communication Zoetis Global Risk Management Zoetis Inc. believes that the information contained in this 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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