MATERIAL SAFETY DATA SHEET
Product Name : BRAVECTO Chewable Tablets for Dogs
MATERIAL SAFETY DATA SHEET
Version 1 issued : February , 2015 Page : 6 of 11
Section 10 - Stability and Reactivity
Reactivity : This product is unlikely to react or decompose under normal storage conditions . Conditions to Avoid : Keep product away from direct sunlight . Incompatibilities : Avoid food products . Strong acids and bases . Strong oxidizers . Fire Decomposition : Carbon dioxide , and if combustion is incomplete , carbon monoxide and smoke . Water . Carbon monoxide poisoning produces headache , weakness , nausea , dizziness , confusion , dimness of vision , disturbance of judgment , and unconsciousness followed by coma and death .
Polymerisation : This product will not undergo polymerisation reactions .
The most likely routes of exposure are oral and dermal .
Section 11 - Toxicological Information
Studies in laboratory animals demonstrate that Fluralaner has low acute toxicity by oral and dermal routes ( oral rat LD50 > 2000 mg / kg bw ; dermal rat LD50 > 2000 mg / kg bw ). In the case of an accidental ingestion of the maximum administered single dose , comparison with the oral LD50 values indicate a margin of exposure of ~ 4-fold ( 2000 mg / kg bw ( LD50 ) I 560 mg / kg bw exposure ).
Local Effects : In single dose dermal toxicity testing in rats , local effects observed in some animals included erythema , scaling and scabs .
Target Organs : The liver is the main elimination organ of fluralaner and a sensitive target for effects . These changes are considered to be reversible . ( see Subchronic / chronic toxicity below ).
The information presented below pertains to the following individual ingredients , and not to the mixture ( s ).
ACUTE TOXICITY DATA INHALATION : No mortalities were reported in rats ( 0 / 6 ) following a 4-hour exposure to polyethylene glycol vapours generated at 170 º C ; however , mortality was observed in all rats ( 6 / 6 ) following an 8-hour exposure to polyethylene glycol vapors generated at 170 º C . Glycerin : Inhalation LC50 ( 1hr ): > 570 mg / m 3 [> 0 . 57 mg / L ] ( rat )
Toxic effects are always dose dependent – and exposure to Polyethylene glycol and Glycerin from the Bravecto chewable tablet is negligible .
SKIN : Fluralaner Dermal LD50 : > 2000 mg / kg ( Rat ). Fluralaner was not irritating to rabbit skin . Polyethylene glycols ( 200-9000 g / mol ): Dermal LD50 : > 20 g / kg ( unspecified species ). Polyethylene glycol was not
irritating to the skin of rabbits and guinea pigs . Polyethylene glycol was not irritating in a human patch test . Glycerin : Skin LD50 : > 10,000 mg / kg ( rabbit ) Glycerin was slightly irritating to the skin of rabbits .
Toxic effects are always dose dependent – and exposure to Polyethylene glycol and Glycerin from the Bravecto chewable tablet is negligible .
EYE : Fluralaner was not irritating to rabbit eyes . Polyethylene glycols did not produce appreciable eye irritation in rabbits . Glycerin was slightly irritating to the eyes of rabbits . Toxic effects are always dose dependent – and exposure to Polyethylene glycol and Glycerin from the Bravecto chewable tablet is negligible .
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 )