Food Saf (Tokyo). 2023 Mar 24;11(1):21-24. doi: 10.14252/foodsafetyfscj.D-23-00002. eCollection 2023 Mar.
Food Safety Commission of Japan (FSCJ) conducted a risk assessment of pyridachlometyl (CAS No.1358061-55-8), a pyridazine fungicide, based on results from various studies. The data used in the assessment include the fate in plants (wheat, sugar beet and others), residues in crops, fate in livestock (goats and chickens), residues in livestock, fate in animals (rats), and tests of subacute toxicity (rats, mice and dogs), chronic toxicity (dogs), combined chronic toxicity/carcinogenicity (rats), carcinogenicity (mice), two-generation reproductive toxicity (rats), developmental toxicity (rats and rabbits), genotoxicity and others. The major adverse effects of pyridachlometyl in experimental animals were observed in body weight (suppressed body weight gain), thyroid (increased weight, hypertrophy of follicular epithelial cell: rats and mice) and liver (increased weight, hepatocellar hypertrophy). No adverse effects were observed in the tests of fertility, teratogenicity or genotoxicity. The lowest no-observed-adverse-effect level (NOAEL) obtained from all the studies was 8 mg/kg bw per day in a two-year combined chronic toxicity/carcinogenicity study in rats. FSCJ specified an acceptable daily intake (ADI) of 0.08 mg/kg bw per day by applying a safety factor of 100 to the NOAEL. It is unnecessary to specify an acute reference dose (ARfD) because of adverse effects not expected to occur via a single administration of pyridacholometyl.
日本食品安全委员会(FSCJ)基于各项研究结果,对哒螨灵(化学物质登记号:1358061-55-8)这一哒嗪类杀菌剂进行了风险评估。评估中使用的数据包括在植物(小麦、甜菜等)中的代谢情况、作物中的残留量、在牲畜(山羊和鸡)中的代谢情况、牲畜中的残留量、在动物(大鼠)中的代谢情况,以及亚急性毒性试验(大鼠、小鼠和狗)、慢性毒性试验(狗)、慢性毒性/致癌性联合试验(大鼠)、致癌性试验(小鼠)、两代生殖毒性试验(大鼠)、发育毒性试验(大鼠和兔子)、遗传毒性试验等。在实验动物中,哒螨灵的主要不良反应体现在体重(体重增加受抑制)、甲状腺(重量增加、滤泡上皮细胞肥大:大鼠和小鼠)和肝脏(重量增加、肝细胞肥大)方面。在生育力、致畸性或遗传毒性试验中未观察到不良反应。在大鼠的一项为期两年的慢性毒性/致癌性联合试验中,所有研究得出的最低未观察到不良反应水平(NOAEL)为每天8毫克/千克体重。FSCJ通过对NOAEL应用100的安全系数,确定每日允许摄入量(ADI)为每天0.08毫克/千克体重。由于预计单次施用哒螨灵不会产生不良反应,因此无需确定急性参考剂量(ARfD)。