The Food Safety Commission of Japan (FSCJ) conducted a risk assessment of picarbutrazox (CAS No.500207-04-5), a methyltetrazole-type fungicide, based on results from various studies. Major adverse effects of picarbutrazox were observed as hepatocellular hypertrophy and hypertrophy of follicular epithelial cells in rats. None of neurotoxicity, reproductive toxicity, teratogenicity and genotoxicity were detected in the experiments described above. Picarbutrazox (parent compound only) and its metabolite B were identified as the relevant substance for the residue definition for dietary risk assessment in agricultural products. The lowest no-observed-adverse-effect level (NOAEL) obtained in all studies was 2.34?mg/kg bw/day in a two-year combined chronic toxicity/carcinogenicity study in rats. FSCJ specified an acceptable daily intake (ADI) of 0.023?mg/kg bw/day, applying a safety factor of 100 to the NOAEL. FSCJ judged it unnecessary to specify an acute reference dose (ARfD), since no adverse effects would be likely to be elicited by a single oral administration.
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机译:日本食品安全委员会(FSCJ)根据各种研究结果,对甲基四唑类杀菌剂picarbutrazox(CAS No.500207-04-5)进行了风险评估。观察到picarbutrazox的主要不良反应是大鼠肝细胞肥大和滤泡上皮细胞肥大。在上述实验中未检测到神经毒性,生殖毒性,致畸性和遗传毒性。 Picarbutrazox(仅母体化合物)及其代谢产物B被确定为农产品中饮食风险评估中残留物定义的相关物质。在一项为期两年的大鼠慢性毒性/致癌性综合研究中,所有研究中获得的最低未观察到不良作用水平(NOAEL)为2.34?mg / kg bw /天。 FSCJ规定可接受的每日摄入量(ADI)为0.023?mg / kg bw /天,NOAEL的安全系数为100。 FSCJ认为没有必要指定急性参考剂量(ARfD),因为单次口服可能不会引起不良反应。
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