Monepantel(兽药产品)

Food safety (Tokyo, Japan) Pub Date : 2020-03-27 eCollection Date: 2020-03-01 DOI:10.14252/foodsafetyfscj.D-20-00001
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引用次数: 1

摘要

FSCJ根据多项研究结果,对杀虫药monepantel (CAS No.887148-69-8)进行了风险评估。新提交了药代动力学(牛)和残留(牛)数据。所有的遗传毒性和致癌性研究结果均为阴性。在所有研究中获得的未观察到的不良反应水平(NOAEL)为100 ppm(相当于男女每天3 mg/kg体重)。在为期52周的犬类慢性毒性研究中,FSCJ在NOAEL为3 mg/kg bw / day的基础上,应用安全系数为100,规定了monepantel的每日推荐摄入量为0.03 mg/kg bw。
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Monepantel (Veterinary Medicinal Products).

FSCJ conducted a risk assessment of monepantel (CAS No.887148-69-8), a parasiticide based on results from various studies. Data on pharmacokinetics (cattle) and residues (cattle) were newly submitted. Negative results were obtained in all genotoxicity and carcinogenicity studies. The no-observed-adverse-effect level (NOAEL) obtained in all studies was 100 ppm (equivalent to 3 mg/kg bw per day for both sexes). In the 52-week chronic toxicity study in dogs, FSCJ specified an ADI for monepantel at 0.03 mg/kg bw per day based on NOAEL of 3 mg/kg bw per day, by applying a safety factor of 100.

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