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首页> 外文期刊>Critical reviews in toxicology >Critical evaluation of key evidence on the human health hazards of exposure to bisphenol A.
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Critical evaluation of key evidence on the human health hazards of exposure to bisphenol A.

机译：对暴露于双酚A对人类健康的危害的主要证据的关键评价。

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Despite the fact that more than 5000 safety-related studies have been published on bisphenol A (BPA), there seems to be no resolution of the apparently deadlocked controversy as to whether exposure of the general population to BPA causes adverse effects due to its estrogenicity. Therefore, the Advisory Committee of the German Society of Toxicology reviewed the background and cutting-edge topics of this BPA controversy. The current tolerable daily intake value (TDI) of 0.05 mg/kg body weight [bw]/day, derived by the European Food Safety Authority (EFSA), is mainly based on body weight changes in two- and three-generation studies in mice and rats. Recently, these studies and the derivation of the TDI have been criticized. After having carefully considered all arguments, the Committee had to conclude that the criticism was scientifically not justified; moreover, recently published additional data further support the reliability of the two- and three-generation studies demonstrating a lack of estrogen-dependent effects at and below doses on which the current TDI is based. A frequently discussed topic is whether doses below 5 mg/kg bw/day may cause adverse health effects in laboratory animals. Meanwhile, it has become clear that positive results from some explorative studies have not been confirmed in subsequent studies with higher numbers of animals or a priori defined hypotheses. Particularly relevant are some recent studies with negative outcomes that addressed effects of BPA on the brain, behavior, and the prostate in rodents for extrapolation to the human situation. The Committee came to the conclusion that rodent data can well be used as a basis for human risk evaluation. Currently published conjectures that rats are insensitive to estrogens compared to humans can be refuted. Data from toxicokinetics studies show that the half-life of BPA in adult human subjects is less than 2 hours and BPA is completely recovered in urine as BPA-conjugates. Tissue deconjugation of BPA-glucuronide and -sulfate may occur. Because of the extremely low quantities, it is only of minor relevance for BPA toxicity. Biomonitoring studies have been used to estimate human BPA exposure and show that the daily intake of BPA is far below the TDI for the general population. Further topics addressed in this article include reasons why some studies on BPA are not reproducible; the relevance of oral versus non-oral exposure routes; the degree to which newborns are at higher systemic BPA exposure; increased BPA exposure by infusions in intensive care units; mechanisms of action other than estrogen receptor activation; and the current regulatory status in Europe, as well as in the USA, Canada, Japan, New Zealand, and Australia. Overall, the Committee concluded that the current TDI for BPA is adequately justified and that the available evidence indicates that BPA exposure represents no noteworthy risk to the health of the human population, including newborns and babies.
机译：尽管已经发表了超过5000项有关双酚A（BPA）的安全性相关研究，但似乎尚无解决有关一般人群是否因双酚A的雌激素性而引起不良影响的僵局的争论。因此，德国毒理学学会咨询委员会审查了该BPA争议的背景和前沿话题。由欧洲食品安全局（EFSA）得出的当前容许的每日摄入量（TDI）为0.05 mg / kg体重[bw] /天，主要基于两代和三代小鼠的体重变化和老鼠。最近，这些研究和TDI的派生受到了批评。在仔细考虑了所有论点之后，委员会不得不得出结论，从科学上讲，这种批评是没有道理的。此外，最近发表的其他数据进一步支持了两代和三代研究的可靠性，表明在当前TDI所基于的剂量及以下剂量下，缺乏雌激素依赖性作用。经常讨论的话题是剂量低于5 mg / kg bw /天是否会对实验动物造成不利的健康影响。同时，很明显的是，在更多动物或先验定义假说的后续研究中，尚未证实某些探索性研究的积极结果。与之相关的一些近期研究尤其具有相关性，这些研究的结果都是负面的，涉及双酚A对啮齿动物大脑，行为和前列腺的影响，以推断出人类的状况。委员会得出的结论是，啮齿动物数据可以很好地用作人类风险评估的基础。可以驳斥当前公开的推测，即与人类相比，大鼠对雌激素不敏感。毒物代谢动力学研究的数据表明，成年人体内BPA的半衰期少于2小时，尿液中的BPA作为BPA结合物可以完全恢复。 BPA-葡糖醛酸和-硫酸盐可能会发生组织解偶联。由于数量极少，因此它与BPA毒性无关。生物监测研究已被用来估计人的双酚A暴露量，并表明双酚A的每日摄入量远低于一般人群的TDI。本文讨论的其他主题包括为何某些关于BPA的研究不可重现的原因;口服与非口服途径的相关性;新生儿的全身BPA暴露程度如何;通过在重症监护病房中输注而增加的BPA暴露;除雌激素受体激活外的其他作用机制;以及欧洲，美国，加拿大，日本，新西兰和澳大利亚的当前监管状态。总体而言，委员会得出结论认为，目前双酚A的TDI有充分的理由，现有证据表明，双酚A暴露对包括新生儿和婴儿在内的人类健康没有显着风险。

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