Abstract
Food Safety Commission of Japan (FSCJ) conducted a risk assessment of ferimzone (CAS No. 89269-64-7), a pyrimidine hydrazone fungicide, based on submitted documents. A request for reevaluation was made under the Agricultural Chemical Regulation Act. Additional information was submitted by the Ministry of Agriculture, Forestry and Fisheries, which included data on residues in crops (paddy rice) and in livestock products (cattle and chickens), fate in livestock (goats and chickens), and also related published scientific literatures. Major adverse effects of ferimzone were observed in the liver (including centrilobular hypertrophy of hepatocytes) and blood (anemia). Adverse effects were observed on neither fertility, teratogenicity, nor genotoxicity. The lowest no-observed-adverse-effect level (NOAEL) obtained from these studies was 1.94 mg/kg bw per day in the two-year combined chronic toxicity/carcinogenicity study in rats. FSCJ specified an acceptable daily intake (ADI) of 0.019 mg/kg bw per day by applying a safety factor of 100 to this NOAEL. The lowest value was a NOAEL of 30 mg/kg bw per day in the general pharmacological study in mice and rats, as well as the one-year chronic toxicity study in dogs. FSCJ specified an acute reference dose (ARfD) of 0.3 mg/kg bw by applying a safety factor of 100 to this NOAEL.