3-Nitrooxypropanol (Feed Additives).

Food safety (Tokyo, Japan) Pub Date : 2024-06-28 eCollection Date: 2024-06-01 DOI:10.14252/foodsafetyfscj.D-24-00008
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Abstract

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.

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3-硝基氧基丙醇(饲料添加剂)。
日本食品安全委员会(FSCJ)使用饲料添加剂指定评估文件对 3-硝基氧基丙醇(3-NOP)(化学文摘社编号: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,用于减少牛第一胃(瘤胃)中产生的甲烷。评估中使用的数据包括在动物体内的转归(小鼠、大鼠、牛)、残留(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。在对大鼠进行的 52 慢性毒性、104 周慢性毒性/致癌性和两代生殖毒性研究中,3-NOP 可能产生的不良影响的最低无观测不良效应水平(NOAEL)为每天 100 毫克/千克体重。有鉴于此,食品添加剂和污染物法典委员会对无观测不良效应水平采用了 100 的安全系数,规定每日可接受摄入量为 1 毫克/千克体重。
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