Aida Y, Kamata E, Nakadate M
Eisei Shikenjo Hokoku. 1992(110):48-53.
In the risk assessment of chemicals to humans, it is a very important step to determine no-observed-adverse-effect-levels (NOAEL) or lowest-observed-adverse-effect-levels (LOAEL) from animal experiments. Recently, short-term screening tests, such as 28-day repeated dose toxicity test, are carried out in accordance with the regulative guidelines for the safety evaluation of chemicals. However, many problems still remain in the risk assessment to human based on short-term toxicity studies. For this reason, we studied the relationships between the exposure periods and NOAELs or LOAELs in repeated dose toxicity tests using available test results of 18 halogenated compounds. The ratios between each NOAEL or LOAEL of short-term tests (14, 28 days, 13 weeks and 6 month) and those of long-term tests (longer than one year) were calculated on the basis of same animal species, route and toxic effect. From this study, it was considered that exposures above 13 weeks were needed to satisfy the present safety factor considerations for setting an acceptable daily intake (ADI).
在化学品对人类的风险评估中，通过动物实验确定无观察到不良反应水平（NOAEL）或最低观察到不良反应水平（LOAEL）是非常重要的一步。最近，短期筛选试验，如28天重复剂量毒性试验，是按照化学品安全评价的规范性指南进行的。然而，基于短期毒性研究的人类风险评估中仍存在许多问题。因此，我们利用18种卤代化合物的现有试验结果，研究了重复剂量毒性试验中暴露期与NOAEL或LOAEL之间的关系。基于相同的动物物种、给药途径和毒性效应，计算了短期试验（14天、28天、13周和6个月）与长期试验（超过一年）各自的NOAEL或LOAEL之间的比值。从这项研究可以认为，需要13周以上的暴露时间才能满足目前设定每日可接受摄入量（ADI）的安全系数考量。
