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Product Name: BRAVECTO Chewable Tablets for Dogs …

Product name : BRAVECTO Chewable Tablets for Dogs material safety data SHEET Version 1 issued: February, 2015 Page: 1 of 11 material safety data SHEET Issued by: Intervet Australia Pty Limited (trading as MSD Animal Health) Phone: 1 800 033 461 (Business Hours) Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand) Substance: The active ingredient, FLURALANER synonym Carbamoyl Benzamide Phenyl Isoxazoline (CBPI); belongs to a novel anti-parasitic class of Isoxazoline-substituted benzamide derivatives. It is presented in a suitable tableting blend of ingredients. The finished Product (trade name , BRAVECTO ) are for animal treatment only. Trade name : BRAVECTO Fluralaner Chewable Tablets for Dogs Product Code: 146745 (1400 mg), 146625 (1000 mg), 145606 (500 mg), 127731 (250 mg), 137479 ( mg) Recommended Use: Treatment and prevention of flea (Ctenocephalides felis) infestations; treatment and control of paralysis tick (Ixodes holocyclus) and brown dog tick (Rhipicephalus sanguineus) in dogs.

Product Name: BRAVECTO Chewable Tablets for Dogs MATERIAL SAFETY DATA SHEET Version 1 issued: February, 2015 Page: 1 of 11 MATERIAL SAFETY DATA SHEET

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Transcription of Product Name: BRAVECTO Chewable Tablets for Dogs …

1 Product name : BRAVECTO Chewable Tablets for Dogs material safety data SHEET Version 1 issued: February, 2015 Page: 1 of 11 material safety data SHEET Issued by: Intervet Australia Pty Limited (trading as MSD Animal Health) Phone: 1 800 033 461 (Business Hours) Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand) Substance: The active ingredient, FLURALANER synonym Carbamoyl Benzamide Phenyl Isoxazoline (CBPI); belongs to a novel anti-parasitic class of Isoxazoline-substituted benzamide derivatives. It is presented in a suitable tableting blend of ingredients. The finished Product (trade name , BRAVECTO ) are for animal treatment only. Trade name : BRAVECTO Fluralaner Chewable Tablets for Dogs Product Code: 146745 (1400 mg), 146625 (1000 mg), 145606 (500 mg), 127731 (250 mg), 137479 ( mg) Recommended Use: Treatment and prevention of flea (Ctenocephalides felis) infestations; treatment and control of paralysis tick (Ixodes holocyclus) and brown dog tick (Rhipicephalus sanguineus) in dogs.

2 APVMA No: 68873 ( BRAVECTO 1400 mg Fluralaner Chewable Tablets for Very Large Dogs), 68870 ( BRAVECTO 1000 mg Fluralaner Chewable Tablets for Large Dogs), 68871 ( BRAVECTO 500 mg Fluralaner Chewable Tablets for Medium Sized Dogs), 68872 ( BRAVECTO 250 mg Fluralaner Chewable Tablets for Small Dogs), 68867 ( BRAVECTO mg Chewable Tablets for Very Small Dogs) This version issued: is valid for 5 years from this date. Statement of Hazardous Nature: This Product is classified as: Based on the concentrations of active and other constituents, BRAVECTO Chewable Tablets are not classified as a hazardous substance in accordance with NOHSC Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004).1 Not a Dangerous Good according to the Australian Dangerous Goods (ADG) Code. Risk Phrases: R50 Very toxic to aquatic organisms safety Phrases: S160/211 May irritate the eyes and skin, S210/211 Avoid contact with eyes and skin. S351 Wash hands after use. SUSDP Classification: S5.

3 ADG Classification: None allocated. Not a Dangerous Good under the ADG Code. UN Number: 3077. Physical Description & Colour: Light to dark brown round tablet, may have some marbling and/or specks. Odour: Unknown. 1 Under the current transitional arrangements, classification under the NOHSC Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004) will continue until 31 December 2016, after which Product classification by the GHS will be mandatory. Section 1 - Identification of Chemical Product and Company Section 2 - Hazards Identification Emergency Overview Issued by: Intervet Australia Pty Limited (Trading as MSD Animal Health) 91-105 Harpin Street Tel: 1 800 033 461 (Business hours) Bendigo East, Vic 3550, AUSTRALIA Fax: 1 800 817 414 Company ABN: 79 008 467 034 Product name : BRAVECTO Chewable Tablets for Dogs material safety data SHEET Version 1 issued: February, 2015 Page: 2 of 11 material safety data SHEET Issued by: Intervet Australia Pty Limited (trading as MSD Animal Health) Phone: 1 800 033 461 (Business Hours) Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand) Major Health Hazards: No significant risk factors have been found for this Product .

4 BRAVECTO Fluralaner Chewable Tablets for Dogs (Fluralaner w/w) have low oral and dermal toxicity. In vitro binding specificity studies indicate that fluralaner has little specificity for GABA ligand-gated chloride in mammals, with a high affinity for arthropod receptors. Fluralaner is for veterinary use only and is not present in any products registered for human use. The main route of exposure is accidental or deliberate ingestion. Product is supplied in a child resistant pack. Opportunities for exposure to the Product are further reduced due to BRAVECTO s long action (>3 months against fleas and >4 months against paralysis ticks) - pets are likely to be dosed with BRAVECTO a maximum of 4 times per year. Inhalation: Being an unscored tablet that is administered to dogs whole and not broken, the Product is unlikely to pose an acute inhalation toxicity risk. Short Term Exposure: No data . Long Term Exposure: No data . Skin Contact: Short Term Exposure: Available data indicates that this Product has low dermal toxicity.

5 Slight potential for skin irritation. No skin sensitization potential. Long Term Exposure: No data for health effects associated with long term skin exposure. Eye Contact: Short Term Exposure: This Product may be slightly irritating to eyes, but being an unscored tablet that is typically administered whole, this route of exposure is unlikely during normal use. Long Term Exposure: No data for health effects associated with long term eye exposure. Ingestion: Short Term Exposure: Significant oral exposure is considered to be unlikely during normal use of the Product . No adverse effects are expected from accidental ingestion of BRAVECTO tablet(s). Individual (child resistant) blister packaging limits access to more than one tablet at once. If any symptoms develop or if feeling unwell, seek medical advice immediately. Long Term Exposure: In a 90 day study of fluralaner in rats, the NOAEL was established orally at the highest dose of 400 mg/kg/body weight/day. The liver is the main elimination organ of fluralaner and a sensitive target for effects as reflected by increased liver enzyme activity in blood plasma with decreased lipid and protein concentration, increased organ weight and increased hepatocellular fatty change.

6 In the absence of any indicator of liver injury, these changes are considered to represent reversible metabolic effects. Carcinogen Status: SWA: No significant ingredient is classified as carcinogenic by SWA. NTP: No significant ingredient is classified as carcinogenic by NTP. IARC: No significant ingredient is classified as carcinogenic by IARC. Potential Health Effects Product name : BRAVECTO Chewable Tablets for Dogs material safety data SHEET Version 1 issued: February, 2015 Page: 3 of 11 material safety data SHEET Issued by: Intervet Australia Pty Limited (trading as MSD Animal Health) Phone: 1 800 033 461 (Business Hours) Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand) Ingredients CAS No GHS CLASSIFICATION TWA (mg/m3) STEL (mg/m3) Fluralaner 864731-61-3 Aquatic Acute 1 (H400) not set not set Polyethylene glycol 25322-68-3 10 - 20 not set not set Starch 9005-25-8 10 - 20 10 not set Glycerin (mist) 56-81-5 <10 10 not set Sucrose 57-50-1 <10 10 not set Other non-hazardous ingredients secret to 100 not set not set This is a commercial Product whose exact ratio of components may vary slightly.

7 Minor quantities of other non hazardous ingredients are also possible. The SWA TWA exposure value is the average airborne concentration of a particular substance when calculated over a normal 8 hour working day for a 5 day working week. The STEL (Short Term Exposure Limit) is an exposure value that may be equalled (but should not be exceeded) for no longer than 15 minutes and should not be repeated more than 4 times per day. There should be at least 60 minutes between successive exposures at the STEL. The term "peak "is used when the TWA limit, because of the rapid action of the substance, should never be exceeded, even briefly. General Information: You should call The Poisons Information Centre if you feel that you may have been poisoned, burned or irritated by this Product . The number is 13 11 26 from anywhere in Australia (0800 764 766 in New Zealand) and is available at all times. Have this MSDS with you when you call. Inhalation: First aid is not generally required.

8 If in doubt, contact a Poisons Information Centre or a doctor. Skin Contact: Irritation is unlikely following skin contact. However, if irritation does occur, flush with lukewarm, gently flowing water for 5 minutes or until chemical is removed. Eye Contact: In the unlikely event of eye contact, immediately rinse eyes thoroughly with plenty of water. If wearing contact lenses, remove only after initial rinse, and continue rinsing eyes for at least 15 minutes. If irritation occurs or persists, consult a physician. Ingestion: If Product is swallowed or gets in mouth, do NOT induce vomiting; rinse mouth with water and give some water to drink. If symptoms develop, or if in doubt contact a Poisons Information Centre or a doctor. Fire and Explosion Hazards: There is no risk of an explosion from this Product under normal circumstances if it is involved in a fire. Fire decomposition products from this Product may be toxic if inhaled. Take appropriate protective measures. Extinguishing Media: Preferred extinguishing media are carbon dioxide, dry chemical, water fog.

9 Fire Fighting: If a significant quantity of this Product is involved in a fire, call the fire brigade. Flash point: Combustible solid. Upper Flammability Limit: No data . Lower Flammability Limit: No data . Autoignition temperature: No data . Flammability Class: Combustible solid. Section 3 - Composition/Information on Ingredients Section 4 - First Aid Measures Section 5 - Fire Fighting Measures Product name : BRAVECTO Chewable Tablets for Dogs material safety data SHEET Version 1 issued: February, 2015 Page: 4 of 11 material safety data SHEET Issued by: Intervet Australia Pty Limited (trading as MSD Animal Health) Phone: 1 800 033 461 (Business Hours) Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand) Accidental release: Sweep up and shovel or collect recoverable Product into labelled containers for recycling or salvage, and dispose of promptly. Consider vacuuming if appropriate. Product is toxic to aquatic organisms.

10 Take steps to ensure spilled Product does not enter waterways. If a significant quantity of material enters drains, advise emergency services. This material may be suitable for approved landfill. Ensure legality of disposal by consulting regulations prior to disposal. Thoroughly launder protective clothing before storage or re-use. Advise laundry of nature of contamination when sending contaminated clothing to laundry. Handling: Keep exposure to this Product to a minimum, and minimise the quantities kept in work areas. Check Section 8 of this MSDS for details of personal protective measures, and make sure that those measures are followed. The measures detailed below under "Storage" should be followed during handling in order to minimise risks to persons using the Product in the workplace. Also, avoid contact or contamination of Product with incompatible materials listed in Section 10. Storage: This Product is an S5 Scheduled Poison. Observe all relevant regulations regarding sale, transport and storage of this schedule of poison.


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