SALSPRIN Injection

Creation Date: 12 Feb 2007 Revision Date: Sep 2011 Version: 2 Next revision due: Sep 2016

Material Safety Data Sheet SALSPRIN Injection

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COMPANY DETAILS Company: Address: Ceva Animal Health Pty Ltd 11 Moores Road ABN 54 002 692 426 Glenorie NSW 2157 Australia Telephone Number: Facsimile Number: +61 (02) 9652 7000 +61 (02) 9652 7001 Emergency Telephone Number: +61 (02) 9652 7000 (Business Hours) Poisons Information Centre: 131126

SUBSTANCE IDENTIFICATION Product Name: NV Salsprin Injection Other Names: Salsprin Chemical name of active constituent, Sodium Salicylate: Sodium 2-hydroxybenzoate Manufacturer’s Product Code: UN Number: None allocated Dangerous Goods Class and Subsidiary Risk: None allocated Hazchem Code: None allocated SUSDP Poisons Schedule Number: S4 Use: Injectable antiinflammatory, antipyretic and antithrombotic for use in horses and dogs. For animal treatment only.

Section 1 – Identification of Material and Supplier

SALSPRIN Injection

Creation Date: 12 Feb 2007 Revision Date: Sep 2011 Version: 2 Next revision due: Sep 2016

Material Safety Data Sheet SALSPRIN Injection

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Statement of Hazardous Nature: Hazardous according to criteria of NOHSC Australia. Risk Phrases: None. Safety Phrases: None. The substance is a complex mixture, including the following ingredients. Ingredients: Chemical Name CAS Number Proportion Sodium Salicylate 54-21-7 25% (25 mg/mL) Sodium Metabisulfite 7681-57-4 less than 10% Benzyl Alcohol 100-51-6 less than 10% Ingredients determined not to be hazardous

to 100%

Swallowed: If swallowed, immediately contact a doctor or Poisons Information Centre (Phone 131126) and show doctor a copy of this MSDS. Eye: May cause transient eye irritation. If in eyes, hold eyelids open and flush gently with copious quantities of water until substance is removed (up to 15 minutes). Skin: Remove contaminated clothing. Wash skin gently with water and non-abrasive soap. No further measures are normally required. Inhaled: Not expected to be a significant route of exposure during normal use. First Aid Facilities: No specific first aid facilities required.

Section 2 – Hazards Identification

Section 3 – Composition / Information on Ingredients

Section 4 – First Aid Measures

SALSPRIN Injection

Creation Date: 12 Feb 2007 Revision Date: Sep 2011 Version: 2 Next revision due: Sep 2016

Material Safety Data Sheet SALSPRIN Injection

Page 3 of 8

Advice to Doctor: Treat symptomatically. Note the nature of the product (salicylic acid derivative that has analgesic, anti-inflammatory, and antipyretic actions similar to those of aspirin). Fire/Explosion Hazard: There is no risk of explosion from this product. The product is not readily combustible. Flashpoint: Flammability Limits: Not applicable Non-flammable. Extinguishing Media: No specific requirements. Use extinguishing media suited to the environmental materials involved in the fire. Special Fire Fighting Procedures: Wear self-contained breathing apparatus and full protective clothing in accordance with normal fire-fighting procedures. Hazchem Code: None allocated. Emergency Procedures: None prescribed. Methods and Materials for Containment and Clean Up Procedures: Absorb spills with absorbent paper, cloth or other absorbent material (e.g. sand, soil) and dispose of in garbage. Spills may also be washed away with water. Precautions for Safe Handling: No special precautions. Storage: Adhere to storage requirements as listed on label (Store below 25C. Protect from light).

Section 5 – Fire Fighting Measures

Section 6 – Accidental Release Measures

Section 7 – Handling and Storage

SALSPRIN Injection

Creation Date: 12 Feb 2007 Revision Date: Sep 2011 Version: 2 Next revision due: Sep 2016

Material Safety Data Sheet SALSPRIN Injection

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National Exposure Standards: NOHSC has not listed exposure limits for any ingredients in this product. Swallowing and inhalation are not likely under normal conditions of use or storage. Biological Limit Values: No Biological Limit Values have been established for any ingredients in the product. BLVs are reference values for the evaluation of potential health risks in the practice of industrial hygiene. Biological monitoring involves the measurement of substances in biological media (eg blood, urine, etc.) and the measurement of biological effects induced by the substance. Engineering Controls: No engineering controls allocated. Personal Protective Equipment: No specific protective clothing required. Physical Description/Properties: Appearance: Clear colourless to pale straw coloured solution for injection contained in a 100 mL labelled amber glass vial with a rubber stopper and aluminium cap, packaged in a labelled outer carton. Boiling Point Expected to be ~100°C. Melting Point: Expected to be ~ 0°C. Vapour Pressure: No data. Specific Gravity: Not applicable Flashpoint: Not determined Flammability Limits: Not determined Solubility in Water: Miscible in water

Section 8 – Exposure Controls / Personal Protection

Section 9 – Physical and Chemical Properties

SALSPRIN Injection

Creation Date: 12 Feb 2007 Revision Date: Sep 2011 Version: 2 Next revision due: Sep 2016

Material Safety Data Sheet SALSPRIN Injection

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Other Properties: No other information Chemical Stability: Product is not likely to react or decompose under normal storage conditions. Conditions to Avoid: No data. Incompatible Materials: No known incompatibilities. Hazardous Decomposition Products: Upon thermal decomposition, may emit toxic gases including carbon monoxide and carbon dioxide. Hazardous Reactions: No hazardous reactions such as polymerization known. Health Effects: Acute: The following LD50s apply to the active ingredient, Sodium Salicylate. LD50 oral mouse: 540 mg/kg LD50 oral, rat 1200 mg/kg LD50 oral, rabbit 1700 mg/kg The most likely route of exposure is by accidental self injection. Swallowed: More than 10,000 tons of aspirin (a closely related salicylate) are consumed in the United States each year. Salicylate intoxication persists as an important cause of morbidity and mortality1. Signs of acute poisoning may include nausea, vomiting, gastric irritation and thirst, possibly leading to weakness, hypotension (low blood pressure), rapid heart beat, rapid breathing, delirium and respiratory arrest. Eye: May cause transient irritation. Skin: May cause transient irritation. Inhaled: Not a significant route of exposure during normal use of the product.

1 http://emedicine.medscape.com/article/1009987-overview

Section 10 – Stability and Reactivity

Section 11 – Toxicological Information

SALSPRIN Injection

Creation Date: 12 Feb 2007 Revision Date: Sep 2011 Version: 2 Next revision due: Sep 2016

Material Safety Data Sheet SALSPRIN Injection

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Chronic: Medical experience indicates sodium salicylate is of low hazard in usual doses. It is normally rapidly excreted from the body; however in persons with impaired renal function levels in the body may rapidly build up. Prolonged use of non-steroidal analgesics damages the lining of the gastrointestinal tract, causing ulcers and bleeding. There may be diarrhea or constipation, perforations causing serious infection, and blood in the vomit or stools. Kidney damage can result in blood or pus in the urine, changes in urine chemistry, change in the frequency of urination, insufficiency of kidney function, destruction of the kidney lining and kidney inflammation. Occasionally, the liver may be affected, causing inflammation (hepatitis) and jaundice. There may be changes in blood cell distribution, and disturbance in platelet function. Sensitivity to light may occur. Anaphylatic-like syndrome is characterized by rash with redness, spots and blisters, itching, and fainting. The eyes, ears and urinary tract can all be affected. Asthma and anemia may be exacerbated. These drugs can cause circulatory defects in the fetus and newborn. Once the kidney has been damaged, there is an increased likelihood that cancers could develop there. Chronic exposure to salicylates produce problems with metabolism, central system disturbances, or kidney damage. Those with pre-existing damage to the eye, skin or kidney are especially at risk. Hypersensitive reactions can occur, especially in people with asthma. These symptoms include itchy wheals and other skin eruptions, an inflamed nose, shortness of breath and serious narrowing of the airways (which can even cause death). Reproductive Effects: Fertility: Post-implantation mortality, oral-rat TDLo=250 mg/kg. Paternal Effects: Testes/sperm duct/epididymis, intraperitoneal-rat TDLo=600mg/kg.

Teratogenic and mutagenic effects: Exposure to the material for prolonged periods may cause physical defects in the developing embryo (teratogenesis).

Mutagenicity of aspiron in Salmonella: negative

Carcinogenic Effects Not a known carcinogen.

Toxicity to Other Domestic Species: No data. Ecotoxicity: The major pathway that residues could enter the environment is via the urine and faeces of treated animals. Quantities involved are likely to be very small and no adverse effects to the environment are expected. Persistence / Degradability: No data Mobility: No data

Section 12 – Ecological Information

SALSPRIN Injection

Creation Date: 12 Feb 2007 Revision Date: Sep 2011 Version: 2 Next revision due: Sep 2016

Material Safety Data Sheet SALSPRIN Injection

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Disposal of empty or used containers: Dispose of in accordance with Local, State, Federal and EPA (Environmental Protection Authority) waste regulations. UN Number: None allocated Dangerous Goods Class and Subsidiary Risk: None allocated Hazchem Code: None allocated This product is not classified as a Dangerous Good. No special transport conditions. SUSDP Poisons Schedule Number: 4 APVMA Approval Number: 51161 This MSDS contains only information related to safety. For other data, see product literature. Read all labels and package inserts carefully before using this product. Glossary and Acronyms: ADI Acceptable Daily Intake, as listed in the Australian ADI List, August 2003. CAS Number Unique number assigned by the Chemical Abstracts Service, Columbus, Ohio, USA. EMEA European Agency for the Evaluation of Medicinal Products – Committee for

Veterinary Medicinal Products; 7 Westferry Circus, Canary Wharf, London E14 4HB, UK; ph (+44-171) 418 8400; fx (+44-171) 418 8416

Hazchem Code Emergency action code of numbers and letters giving information to emergency services. LD50 Lethal dose for 50 % of a group of specified test animals. MSDS Material Safety Data Sheet (also called Safety Data Sheet in some countries). NOEL No Observable Effect Level, as listed in the Australian ADI List, August 2003. NOHSC National Occupational Health and Safety Commission

Section 13 – Disposal Considerations

Section 14 – Transport Information

Section 15 – Regulatory Information

Section 16 – Other Information

SALSPRIN Injection

Creation Date: 12 Feb 2007 Revision Date: Sep 2011 Version: 2 Next revision due: Sep 2016

Material Safety Data Sheet SALSPRIN Injection

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Risk Phrase Standard phrase describing the hazard of a substance as provided in the NOHSC “Approved Criteria for Classifying Hazardous Substances [NOHSC:1008]” Safety Phrase Standard phrase describing the safe handling, storage or use of personal protective equipment for a material as provided in the NOHSC “Approved Criteria for Classifying Hazardous Substances [NOHSC:1008]” SUSDP Standard for the Uniform Scheduling of Drugs & Poisons TWA Time Weighted Average UN Number United Nations Number

CONTACT POINT Ceva Animal Health Pty Ltd Regulatory Affairs Manager (02) 9652 7000. This information has been collated by technical personnel employing data available from the prime manufacturer of the material. To the best of our knowledge it is true and accurate. It is not intended to be all inclusive and the manner and conditions of use and handling may involve other or additional considerations.

END OF MSDS