Abstract
The Food Safety Commission of Japan (FSCJ) conducted a risk assessment of cyclaniliprole (CAS No. 1031756-98-5), an anthranilamide insecticide, based on results from various studies. Major treatment-related effects of cyclaniliprole were observed on liver (increased liver weight and increased alkaline phosphatase) in dogs and on thyroid (hypertrophy of follicular epithelial cells) in rats. None of neurotoxicity, carcinogenicity, reproductive toxicity, teratogenicity, immunotoxicity and genotoxicity were observed. Based on the results from various studies, only parent cyclaniliprole was identified as the relevant substance to the residue definition for dietary risk assessment in agricultural products. The lowest no-observed-adverse-effect level (NOAEL) obtained in all the toxicity studies was 1.29 mg/kg bw/day in a one-year chronic toxicity study in dogs. FSCJ has established an acceptable daily intake (ADI) of 0.012 mg/kg bw/day, by applying a safety factor of 100 to the NOAEL. FSCJ judged it unnecessary to specify an acute reference dose (ARfD) since no adverse effects, possibly elicited by a single oral administration, was observed.
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