Abstract
FSCJ conducted a risk assessment of monepantel (CAS No.887148-69-8), a parasiticide based on results from various studies. Data on pharmacokinetics (cattle) and residues (cattle) were newly submitted. Negative results were obtained in all genotoxicity and carcinogenicity studies. The no-observed-adverse-effect level (NOAEL) obtained in all studies was 100 ppm (equivalent to 3 mg/kg bw per day for both sexes). In the 52-week chronic toxicity study in dogs, FSCJ specified an ADI for monepantel at 0.03 mg/kg bw per day based on NOAEL of 3 mg/kg bw per day, by applying a safety factor of 100.
Highlights
FSCJ conducted a risk assessment of monepantel (CAS No.887148-69-8), a parasiticide based on results from various studies
In the 52-week chronic toxicity study in dogs, FSCJ specified an acceptable daily intake (ADI) for monepantel at 0.03 mg/kg bw per day based on no-observed-adverse-effect level (NOAEL) of 3 mg/kg bw per day, by applying a safety factor of 100
The data used in the assessment include pharmacokinetics, residues, genotoxicity, acute toxicity, subacute toxicity, chronic toxicity, carcinogenicity, and reproductive and developmental toxicity as well as data on general pharmacology
Summary
Negative results were obtained in all genotoxicity and carcinogenicity studies. The no-observed-adverse-effect level (NOAEL) obtained in all studies was 100 ppm (equivalent to 3 mg/kg bw per day for both sexes).
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