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, Ntzani Evangelia, Petersen Annette, Sand Salomon, Schwerdtle Tanja, Vleminckx Christiane, Wallace Heather, Falandysz Jerzy, Hart Andrew, Rose Martin, Anastassiadou Maria, Eskes Chantra, Gergelova Petra, Innocenti Matteo, Rovesti Elena, Whitty Ben, Nielsen Elsa
EFSA J. 2024 Mar 12;22(3):e8640. doi: 10.2903/j.efsa.2024.8640. eCollection 2024 Mar.
EFSA was asked for a scientific opinion on the risks for animal and human health related to the presence of polychlorinated naphthalenes (PCNs) in feed and food. The assessment focused on hexaCNs due to very limited data on other PCN congeners. For hexaCNs in feed, 217 analytical results were used to estimate dietary exposures for food-producing and non-food-producing animals; however, a risk characterisation could not be performed because none of the toxicological studies allowed identification of reference points. The oral repeated dose toxicity studies performed in rats with a hexaCN mixture containing all 10 hexaCNs indicated that the critical target was the haematological system. A BMDL of 0.05 mg/kg body weight (bw) per day was identified for a considerable decrease in the platelet count. For hexaCNs in food, 2317 analytical results were used to estimate dietary exposures across dietary surveys and age groups. The highest exposure ranged from 0.91 to 29.8 pg/kg bw per day in general population and from 220 to 559 pg/kg bw per day for breast-fed infants with the highest consumption of breast milk. Applying a margin of exposure (MOE) approach, the estimated MOEs for the high dietary exposures ranged from 1,700,000 to 55,000,000 for the general population and from 90,000 to 230,000 for breast-fed infants with the highest consumption of breast milk. These MOEs are far above the minimum MOE of 2000 that does not raise a health concern. Taking account of the uncertainties affecting the assessment, the Panel concluded with at least 99% certainty that dietary exposure to hexaCNs does not raise a health concern for any of the population groups considered. Due to major limitations in the available data, no assessment was possible for genotoxic effects or for health risks of PCNs other than hexaCNs.
欧洲食品安全局（EFSA）被要求就饲料和食品中多氯萘（PCNs）的存在对动物和人类健康的风险提供科学意见。由于其他PCN同系物的数据非常有限，评估主要集中在六氯萘（hexaCNs）上。对于饲料中的六氯萘，利用217个分析结果来估计产食动物和非产食动物的膳食暴露量；然而，由于没有毒理学研究能够确定参考点，因此无法进行风险特征描述。在大鼠中进行的关于含有全部10种六氯萘的混合物的口服重复剂量毒性研究表明，关键靶器官是血液系统。确定血小板计数显著下降的每日经口基准剂量下限（BMDL）为0.05毫克/千克体重。对于食品中的六氯萘，利用2317个分析结果来估计不同膳食调查和年龄组的膳食暴露量。一般人群的最高暴露量范围为每天0.91至29.8皮克/千克体重，母乳喂养量最高的婴儿的最高暴露量范围为每天220至559皮克/千克体重。采用暴露边际（MOE）方法，一般人群高膳食暴露量的估计MOE范围为1700000至55000000，母乳喂养量最高的婴儿的估计MOE范围为90000至230000。这些MOE远高于不会引起健康担忧的最低MOE值2000。考虑到影响评估的不确定性，专家小组至少有99%的把握得出结论：六氯萘的膳食暴露不会对所考虑的任何人群组造成健康担忧。由于现有数据存在重大局限性，无法对六氯萘以外的PCNs的遗传毒性效应或健康风险进行评估。
