Food Saf (Tokyo). 2024 Jun 28;12(2):52-53. doi: 10.14252/foodsafetyfscj.D-24-00008. eCollection 2024 Jun.
Food Safety Commission of Japan (FSCJ) conducted a risk assessment of 3-nitrooxypropanol (3-NOP) (CAS No. 100502-66-7), using the evaluation documents for feed additive designation. This feed additive is a nitrate ester of 1,3-propanediol developed to reduce methane generated in the first stomach of cattle (rumen). The data used in the assessment include the fate in animals (mice, rats, cattle), residues (cattle), genotoxicity, acute toxicity (rats), subacute toxicity (mice, rats and dogs), chronic toxicity/carcinogenicity (rats), reproductive/developmental toxicity (rats and rabbits), and others. The lowest no-observed-adverse-effect level (NOAEL) for possible adverse effects of 3-NOP was 100 mg/kg bw per day in 52-chronic toxicity, 104-week chronic toxicity/carcinogenicity, and two-generation reproductive toxicity studies in rats. Given this, FSCJ specified an acceptable daily intake (ADI) of 1 mg/kg bw per day by applying a safety factor of 100 to the NOAEL.
日本食品安全委员会（FSCJ）利用饲料添加剂指定评估文件，对3-硝基氧基丙醇（3-NOP）（化学物质登录号：100502-66-7）进行了风险评估。这种饲料添加剂是1,3-丙二醇的硝酸酯，旨在减少牛的第一胃（瘤胃）中产生的甲烷。评估中使用的数据包括在动物（小鼠、大鼠、牛）体内的代谢情况、残留情况（牛）、遗传毒性、急性毒性（大鼠）、亚急性毒性（小鼠、大鼠和狗）、慢性毒性/致癌性（大鼠）、生殖/发育毒性（大鼠和兔子）等。在大鼠的52周慢性毒性试验、104周慢性毒性/致癌性试验以及两代生殖毒性试验中，3-NOP可能产生的不良反应的最低未观察到有害作用水平（NOAEL）为每天100毫克/千克体重。据此，FSCJ通过将安全系数设为100应用于NOAEL，确定每日允许摄入量（ADI）为每天1毫克/千克体重。
