Section 1 Identification of Material and Supplier

Transcription

1 Section 1 Identification of Material and Supplier COMPANY DETAILS Company: Ceva Animal Health ABN Address: 11 Moores Road Glenorie NSW 2157 Australia Telephone Number: Facsimile Number: +61 (02) (02) Emergency Telephone Number: +61 (02) (Business Hours) Poisons Information Centre: SUBSTANCE IDENTIFICATION Product Name: NV PEPTOSYL BISMUTH SALICYLATE ORAL SUSPENSION Other Names: PEPTOSYL UN Number: None allocated Dangerous Goods Class and Subsidiary Risk: None allocated Hazchem Code: None allocated SUSDP Poisons Schedule Number: Not Scheduled Use: A suspension for oral administration to aid in the treatment of gastroenteritis and diarrhoea in horses and dogs. For animal treatment only. Section 2 Hazards Identification Statement of Hazardous Nature: Not hazardous according to criteria of NOHSC Australia. Risk Phrases: Not hazardous no risk phrases identified. Safety Phrases: Not hazardous no safety phrases identified. Page 1 of 8

2 Section 3 Composition / Information on Ingredients Ingredients: Chemical Name CAS Number Proportion % w/w * Bismuth Subsalicylate % Sodium Bentonite % Methyl Salicylate % Vitamin B12 (Cyanocobalamin) trace other ingredients determined not to be <10% hazardous Water To volume Section 4 First Aid Measures Swallowed: Accidental or deliberate consumption of the product is unlikely to cause any adverse effects unless large volumes are consumed (eg an entire container). May cause darkening of the faeces. In the absence of other effects, this is not cause for concern. Eye: Skin: Inhaled: May cause transient irritation. If in eyes, hold eyes open and flood with water for at least 15 minutes. If spilled on skin, remove contaminated clothing and wash skin with soap and water. Not a significant route of exposure during normal use. First Aid Facilities: No specific first aid facilities required. Advice to Doctor: In the unlikely event that adverse effects occur following accidental or deliberate ingestion of the product, treat supportively and symptomatically. Section 5 Fire Fighting Measures Fire/Explosion Hazard: There is no risk of explosion from this product. The product is water based and not readily combustible. Flashpoint: Not applicable. Flammability Limits: Not determined. Extinguishing Media: Use water, foam or powder extinguishing media suited to the environmental materials involved in the fire (not carbon dioxide). Special Fire Fighting Procedures: Wear self-contained breathing apparatus and full protective clothing in accordance with normal fire-fighting procedures. Page 2 of 8

3 Hazchem Code: None allocated. Page 3 of 8

4 Section 6 Accidental Release Measures Mop up spills promptly. Emergency Procedures: None prescribed. Methods and Materials for Containment and Clean Up Procedures: Mop up spills or absorb with paper. Contaminated absorbent may be disposed of in garbage. Rinse area well with water. Section 7 Handling and Storage Precautions for Safe Handling: Avoid contact with skin and eyes. See Section 8 Exposure Controls and Personal Protection for details of personal protection measures. Storage: Store below 30 C (Room Temperature). Keep out of reach of children. Section 8 Exposure Controls / Personal Protection National Exposure Standards: NOHSC has not listed exposure limits (airborne concentrations) for product ingredients in an end use product in liquid form. Biological Limit Values: No BLVs have been established for the ingredients in this 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 for normal use. Section 9 Physical and Chemical Properties Appearance: Pink liquid. Odour: No data. ph: No data. Vapour pressure/density: Not determined. Boiling Point: Expected to be close to 100 C. Page 4 of 8

5 Freezing / Melting Point: Expected to be close to 0 C.. Solubility: Product is water based. Specific Gravity: ~1.0 g/ml. Other Properties: No other information. Section 10 Stability and Reactivity Chemical Stability: Product is not likely to react or decompose under normal storage conditions. Product colour may change and quality of product be adversely affected if exposed to conditions of heat or light for extended periods. Conditions to Avoid: Avoid conditions of extreme heat, and exposure to light. Incompatible Materials: Alkali solutions. Hazardous Decomposition Products: Upon thermal decomposition, may emit toxic and irritating gases including hydrocarbons and carbon monoxide. Hazardous Reactions: No hazardous reactions such as polymerization known. Section 11 Toxicological Information Health Effects: Bismuth is a non-essential trace elementthe normal daily intake in humans is estimated to be 5 to 20 µg 1. Bismuth subsalicylate is used in human (and veterinary) medicine for antacid action and for mildly astringent action in gastrointestinal disorders including flatulence, diarrhoea and ulcerative gastritis and colitis.. The bacterium Helicobacter pylori is thought to predispose patients with chronic gastritis to peptic ulcer formation and the antibacterial action of bismuth compounds makes them effective in treating peptic ulcers. In human medicine, the recommended oral dose for different bismuth salts (subsalicylate, subnitrate, subcarbonate expressed as bismuth is mg (approx mg/kg bw/day) 3 to 4 times per day for several days/weeks. Chronic No chronic effects have been reported with use of Peptosyl. Absorption of salicylate follows oral administration of bismuth salicylate; therefore effects of chronic salicylate toxicity could potentially occur following chronic oral administration of Peptosyl. Symptoms of chronic salicylate toxicity in humans consist of gastrointestinal disturbances such as nausea, vomititing, gastric ulceration, and prolonged bleeding time. Symptoms of chronic bismuth toxicity consist of decreased appetite, weakness, nephrotoxicity, osteoarthropathy, rheumatic pain, hepatotoxicity, stomatitis, diarrhoea, fever, metal line on gums, foul breath, gingivitis and dermatitis (Cassarett & Doull s Toxicology, 5 th ed. 1996, EMEA 1999). The possibility of bismuth toxicity is remote as it develops only from excessive dosage (repeated ingestion of bismuth over a long period of time or intramuscular injections). 1 EMEA Summary report for bismuth subnitrate, bismuth subcarbonate, bismuth subgallate, bismuth subsalicylate, CVMP Page 5 of 8

6 Acute: No LD50 data are available for the active ingredient, bismuth subsalicylate. Swallowed: No toxic effects expected. In the unlikely event that any adverse effects occur, contact a doctor. Eye: Avoid contact with eyes. Skin: Absorption via intact skin is unlikely. Inhaled: Absorption via inhalation is unlikely. Reproductive Effects: No data. However, bismuth subsalicylate is used in human medicine and the risk of toxic effects is reportedly very low (EMEA 1999) Teratogenic and mutagenic effects: No data. However, bismuth subsalicylate and other bismuth compounds are used in human medicine in large amounts and the risk of toxic effects is reportedly very low (EMEA 1999) Carcinogenic Effects: Early carcinogenic studies (not to today s standards) with bismuth compounds indicated no carcinogenic effects. Toxicity to Other Domestic Species: No toxicity to other species expected with normal use. Section 12 Ecological Information Ecotoxicity: No environmental toxicity expected at concentrations of ingredients i Persistence / Degradability: The additional bismuth that may be added to the environment following a spill for example, would be trivial compared to the naturally occurring bismuth already present in the environment. Bismuth is about twice as abundant as gold in the Earth's crust. Bismuth is not known to be toxic compared to its periodic table neighbours (lead, antimony, and polonium). Mobility: Ingredients are water soluble and high mobility in the soil and aqueous compartments can be expected. Section 13 Disposal Considerations Spilled liquid may be slippery. Wipe up any spills immediately, using cloth, paper or suitable absorbent material. Spills do not constitute an environmental hazard. Large spills can be safely disposed of by incorporating into soil. Small spills and used containers can be placed in garbage. Section 14 Transport Information UN Number: None allocated Page 6 of 8

7 Dangerous Goods Class and Subsidiary Risk: None allocated Hazchem Code: None allocated ADG Code: This product is not classified as a Dangerous Good. No special transport conditions are necessary unless required by other regulations. Page 7 of 8

8 Section 15 Regulatory Information SUSDP Poisons Schedule Number: None allocated APVMA Approval Number: Section 16 Other Information 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 CAS Number Unique number assigned by the Chemical Abstracts Service, Columbus, Ohio, USA. 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 (also called Safety Data Sheet in some countries). NOEL No Observable Effect Level, as listed in the Australian ADI List, August NOHSC National Occupational Health and Safety Commission 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 Regulatory Affairs Manager (02) 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 Page 8 of 8