Schrenk Dieter, Bignami Margherita, Bodin Laurent, Chipman James Kevin, Del Mazo Jesús, Grasl-Kraupp Bettina, Hogstrand Christer, Hoogenboom Laurentius Ron, Leblanc Jean-Charles, Nebbia Carlo Stefano, Nielsen Elsa, Ntzani Evangelia, Petersen Annette, Sand Salomon, Vleminckx Christiane, Wallace Heather, Barregård Lars, Benford Diane, Dogliotti Eugenia, Francesconi Kevin, Gómez Ruiz Jose Ángel, Steinkellner Hans, Tauriainen Tuuli, Schwerdtle Tanja
EFSA J. 2024 Jul 2;22(7):e8844. doi: 10.2903/j.efsa.2024.8844. eCollection 2024 Jul.
The European Commission asked EFSA for a risk assessment on small organoarsenic species in food. For monomethylarsonic acid MMA(V), decreased body weight resulting from diarrhoea in rats was identified as the critical endpoint and a BMDL of 18.2 mg MMA(V)/kg body weight (bw) per day (equivalent to 9.7 mg As/kg bw per day) was calculated as a reference point (RP). For dimethylarsinic acid DMA(V), increased incidence in urinary bladder tumours in rats was identified as the critical endpoint. A BMDL of 1.1 mg DMA(V)/kg bw per day (equivalent to 0.6 mg As/kg bw per day) was calculated as an RP. For other small organoarsenic species, the toxicological data are insufficient to identify critical effects and RPs, and they could not be included in the risk assessment. For both MMA(V) and DMA(V), the toxicological database is incomplete and a margin of exposure (MOE) approach was applied for risk characterisation. The highest chronic dietary exposure to DMA(V) was estimated in 'Toddlers', with rice and fish meat as the main contributors across population groups. For MMA(V), the highest chronic dietary exposures were estimated for high consumers of fish meat and processed/preserved fish in 'Infants' and 'Elderly' age class, respectively. For MMA(V), an MOE of ≥ 500 was identified not to raise a health concern. For MMA(V), all MOEs were well above 500 for average and high consumers and thus do not raise a health concern. For DMA(V), an MOE of 10,000 was identified as of low health concern as it is genotoxic and carcinogenic, although the mechanisms of genotoxicity and its role in carcinogenicity of DMA(V) are not fully elucidated. For DMA(V), MOEs were below 10,000 in many cases across dietary surveys and age groups, in particular for some 95th percentile exposures. The Panel considers that this would raise a health concern.
欧盟委员会要求欧洲食品安全局对食品中的小有机砷物种进行风险评估。对于一甲基胂酸MMA(V),腹泻导致大鼠体重减轻被确定为关键终点,计算得出的基准剂量下限为每天18.2毫克MMA(V)/千克体重(相当于每天9.7毫克砷/千克体重),作为参考点(RP)。对于二甲基胂酸DMA(V),大鼠膀胱肿瘤发病率增加被确定为关键终点。计算得出的基准剂量下限为每天1.1毫克DMA(V)/千克体重(相当于每天0.6毫克砷/千克体重),作为参考点。对于其他小有机砷物种,毒理学数据不足以确定关键影响和参考点,因此无法纳入风险评估。对于MMA(V)和DMA(V),毒理学数据库均不完整,因此采用暴露边际(MOE)方法进行风险特征描述。估计“幼儿”群体对DMA(V)的慢性膳食暴露最高,大米和鱼肉是各人群组中的主要贡献食物。对于MMA(V),估计“婴儿”和“老年人”年龄组中鱼肉和加工/腌制鱼类的高消费者对MMA(V)的慢性膳食暴露最高。对于MMA(V),确定MOE≥500不会引发健康问题。对于MMA(V),所有平均消费者和高消费者的MOE均远高于500,因此不会引发健康问题。对于DMA(V),由于其具有基因毒性和致癌性,确定MOE为10,000时健康风险较低,尽管DMA(V)的基因毒性机制及其在致癌性中的作用尚未完全阐明。在许多膳食调查和年龄组中,特别是对于一些第95百分位数的暴露情况,DMA(V)的MOE低于10,000。专家小组认为这会引发健康问题。