Monepantel (Veterinary Medicinal Products)

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.