Lu F C
Regul Toxicol Pharmacol. 1985 Dec;5(4):460-4. doi: 10.1016/0273-2300(85)90009-1.
Toxicological evaluation of chemicals with thresholded effects involves the estimation of their acceptable daily intakes (ADI). The following steps are involved in the evaluation: judging the completeness of the available chemical and biological data, determination of the no-effect level (NEL), selection of an appropriate safety factor, and extrapolation of the NEL to the ADI using the selected safety factor. The relative insignificance of the sample size on the NEL, the advantages of body weight (compared to the body surface) as a basis for interspecies extrapolation, the size of the safety factor as a function of the nature of the toxic effects, and the multiplicity of the toxicological investigations, in addition to the conventional short-term and long-term toxicity studies, are described. In addition, the possible inadvisability of overemphasizing the importance of dose-response relationship at the expense of in-depth, relevant studies is discussed.
对具有阈值效应的化学品进行毒理学评估涉及估计其每日允许摄入量（ADI）。评估包括以下步骤：判断现有化学和生物学数据的完整性、确定无效应水平（NEL）、选择合适的安全系数，以及使用选定的安全系数将NEL外推至ADI。文中描述了样本量对NEL的相对不重要性、作为种间外推基础的体重（与体表面积相比）的优势、安全系数大小与毒性效应性质的函数关系，以及除传统的短期和长期毒性研究外毒理学研究的多样性。此外，还讨论了以深入、相关研究为代价过度强调剂量-反应关系重要性可能带来的不可取性。
