Food Saf (Tokyo). 2018 Dec 21;6(4):160-161. doi: 10.14252/foodsafetyfscj.2018006s. eCollection 2018 Dec.
The Food Safety Commission of Japan (FSCJ) conducted a self-tasking assessment of mycotoxins, fumonisin B1 (FB1 CAS No. 116355-83-0), fumonisin B2 (FB2 CAS No. 116355-84-1), and fumonisin B3 (FB3 CAS No. 136379-59-4). Hepatotoxicity and/or nephrotoxicity were commonly observed in experimental animals given orally purified FB1, and the sex-related differences were observed in rats and mice. Species differences were also identified: Increased incidences of liver tumors in female mice and of kidney tumors in male rats were observed in chronic toxicity/carcinogenicity studies. Fumonisins did not show appreciable genotoxicity both the and tests. FSCJ judged fumonisins as non-genotoxic carcinogens from the results of various toxicological studies on fumonisins, and thus specified a tolerable daily intake (TDI) of 2 μg/mg bw/day for fumonisins (FB1, FB2 and FB3, alone or by combination), after applying an uncertainty factor of 100 to the lowest no-observed-adverse-effect level (NOAEL) of 0.21 mg/kg bw/day in subacute toxicity study in rats. The estimated exposure levels of fumonisins among high consumers such as toddlers are still below the TDI. Therefore, FSCJ concluded that adverse effect of fumonisin on human health through food are unlikely under the current situation in Japan.
日本食品安全委员会（FSCJ）对霉菌毒素伏马菌素B1（FB1，化学物质登记号116355 - 83 - 0）、伏马菌素B2（FB2，化学物质登记号116355 - 84 - 1）和伏马菌素B3（FB3，化学物质登记号136379 - 59 - 4）进行了自行安排的评估。在经口给予纯化FB1的实验动物中，通常观察到肝毒性和/或肾毒性，并且在大鼠和小鼠中观察到了性别相关差异。还确定了物种差异：在慢性毒性/致癌性研究中，观察到雌性小鼠肝肿瘤发生率增加，雄性大鼠肾肿瘤发生率增加。伏马菌素在 和 试验中均未显示出明显的遗传毒性。基于对伏马菌素进行的各种毒理学研究结果，FSCJ将伏马菌素判定为非遗传毒性致癌物，因此在对大鼠亚急性毒性研究中最低未观察到有害作用水平（NOAEL）为0.21 mg/kg体重/天应用100的不确定系数后，规定伏马菌素（FB1、FB2和FB3单独或组合）的每日可耐受摄入量（TDI）为2 μg/mg体重/天。幼儿等高消费者群体中伏马菌素的估计暴露水平仍低于TDI。因此，FSCJ得出结论，在日本当前情况下，伏马菌素通过食物对人类健康产生不良影响的可能性不大。
