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The inadequacies of pre-market chemical risk assessment's toxicity studiesthe implications

机译：预先市场化工风险评估的毒性研究的不足之处

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Industry provides essentially all the data for most (pre-market) chemical risk assessments (RA); academics study a chemical once it is marketed. For two randomly-chosen high production chemicals, despite new European Union mandates to evaluate all data, just 13% of the herbicide bentazon and 15% of the flame-retardant hexabromocyclododecane's published toxicity studies were found in their pre-market RA, and a systematic review on bentazon concludes it has greater hazards than indicated in its RA. More important, for both, academia's toxicity studies were designated as lower quality than industries were, despite showing hazards at lower doses. The accuracy of industry's test methods is analyzed and found to be replicable but insensitive, thus inaccurate. The synthetic pharmaceutical industry originated them, and by 1983 the Organization for Economic Cooperation & Development mandated their test guidelines (TG) methods be accepted for any new study for pre-market RA. For existing studies, industry's Klimisch criterion is universally used to evaluate quality, but it only states that TG studies produce the best data. However, no TG can answer the realistic exposure effect hypotheses of academics; therefore, crucially in pre-market RA, tens of thousands of published experimental findings (increasingly at low dose) are ignored to determine the safe dose. Few appreciate this, so scientific debate on the most accurate elements of toxicity tests is urgently indicated. Copyright (c) 2016 John Wiley & Sons, Ltd.
机译：行业基本上为大多数（市场）化学风险评估（RA）提供了所有数据;一旦销售，学者就研究了化学品。对于两种随机选择的高生产化学品，尽管新的欧盟授权来评估所有数据，但只有13％的除草剂Bentazon和15％的阻燃六溴环霉癸烷在其前市场的RA和系统审查宾赞顿得出结论，它具有更大的危险，而不是其RA所示。更重要的是，对于学术界的毒性研究虽然表现出较低剂量的危害，但仍被指定为较低的品质。分析了行业测试方法的准确性，发现可复制但不敏感，因此不准确。合成制药行业起源于1983年，截至1983年，经济合作与发展组织授权其检验准则（TG）方法可接受对市场前ra的任何新研究。对于现有研究，行业的Klimisch标准普遍用于评估质量，但它只指出TG研究产生了最佳数据。但是，没有TG可以回答学术界的现实曝光效应假设;因此，至关重要的在市场前Ra中，忽略了成千上万的公布实验结果（越来越低剂量）以确定安全剂量。很少有欣赏这一点，迫切地表明了对最准确的毒性测试元素的科学辩论。版权所有（c）2016 John Wiley＆Sons，Ltd。

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