Scientific Opinion on the safety of allyl isothiocyanate for the proposed uses as a food additive EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)
Scientific Opinion on the safety of allyl isothiocyanate for the proposed uses as a food additive EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)
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DOI：
10.2903/j.efsa.2010.1943
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发表时间：
2010-12-01
期刊：
影响因子：
3.3
通讯作者：
Woutersen, R. A.
中科院分区：
文献类型：
--
作者：
Aguilar, F.;Dusemund, B.;Woutersen, R. A.
食品添加剂和营养来源小组(ANS)就异硫氰酸烯丙酯(AITC)用作食品防腐剂的安全性提供了科学意见。大鼠在AITC代谢方面似乎与人类相似，但清除速度比人类慢得多。AITC已在急性、短期、亚慢性毒性研究和啮齿动物致癌性研究中进行了研究。AITC对大鼠、仓鼠和兔无任何发育毒性。当AITC剂量高于6.0 mg/kg bw/d时，可能对小鼠有胚胎毒性。AITC在小鼠体内不致癌，但在长期的大鼠研究中观察到男性膀胱移行细胞乳头状瘤，但AITC在小鼠和大鼠体内没有遗传毒性。因此，可以假设在这些对膀胱的影响下存在阈值机制。小组认为这项长期老鼠研究是关键研究。专家小组根据9毫克/公斤体重/天的LOAEL并采用不确定因数500计算得出的每日平均每日体重指数为0.018毫克/公斤体重，四舍五入为0.02毫克/公斤体重/天，以涵盖从LOAEL推算到NOAEL以及没有生殖毒性研究所产生的不确定因素。小组注意到，根据暴露情况，儿童和成人的AITC摄入量估计为0.3至2.8倍和0.2至1.6倍。此外，专家小组注意到，根据更精细的模型，从所有来源，包括在食品中天然存在、用作调味品和作为防腐剂使用，平均每天接触AITC的总量，导致儿童的平均每日摄入量超出每日摄入量的2至4倍，第95个百分位数的成人消费者超过摄入量的8倍。
The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on the safety of allyl isothiocyanate ( AITC) when used as a food preservative. Rats appear to resemble humans in AITC metabolism, but have a much slower clearance than humans. AITC has been investigated in acute, short-term, subchronic toxicity studies and in carcinogenicity studies in rodents. AITC did not cause any developmental toxicity in rats, hamsters and rabbits. AITC may be fetotoxic to mice at doses higher than 6.0 mg/kg bw/day. AITC is not carcinogenic in mice but transitional cell papillomas of the urinary bladder of males were observed in a long-term rat study, however, AITC is not genotoxic in vivo in mice and rats. Hence it could be assumed that there is a threshold mechanism underlying these effects on urinary bladder. The Panel considered this long-term rat study as the pivotal study. The Panel derived an ADI of 0.018 mg/kg bw/day which was rounded up to 0.02 mg/kg bw/day based on a LOAEL of 9 mg/kg bw/day and applying an uncertainty factor of 500 in order to cover uncertainties resulting from extrapolation from the LOAEL to the NOAEL and from the absence of reproductive toxicity studies. The Panel noted that AITC intakes resulting only from application as an antispoilage agent could be estimated for children and adults at 0.3 up to 2.8 and 0.2 up to 1.6 times the ADI depending on the exposure scenario. Furthermore, the Panel noted that the mean daily total exposure to AITC from all sources including natural occurrence in food, use as a flavouring and application as an antispoilage agent, based on the more refined model, results in a two to four-fold exceedance of the ADI in children and up to eight-fold exceedance in 95th percentile adult consumers.