Clegg E D, Sakai C S, Voytek P E
Biol Reprod. 1986 Feb;34(1):5-16. doi: 10.1095/biolreprod34.1.5.
In the regulatory process, the hazards posed by potentially toxic agents to the female and male reproductive systems and to developing young are evaluated by risk assessment procedures. In this paper, toxicity testing and the regulatory process are discussed, with emphasis on risk assessment. The suggested testing protocols of the Pesticide Assessment Guidelines (U.S. EPA) are presented as an example of testing that might be done to produce toxicity data for an agent. Protocols and end points that are utilized in testing for reproductive effects are described. Included are acute, subchronic, chronic, and short-term tests. The four components of reproductive risk assessment (hazard identification, dose-response assessment, exposure assessment, and risk characterization) are examined. Effects of dibromochloropropane on rabbit testicular parameters are used to demonstrate approaches that could be taken in doing a reproductive risk assessment. Research needs for screening methods, adequate dose-response testing, toxicokinetics, end point development, and extrapolation methods are identified. Finally, this paper discusses selected areas in which changes in reproductive risk assessment are anticipated, as well as the mechanism for influencing the nature and extent of those changes.
在监管过程中，潜在有毒物质对雌性和雄性生殖系统以及发育中的幼体所造成的危害，通过风险评估程序进行评估。本文讨论了毒性测试和监管过程，重点是风险评估。以《农药评估指南》（美国环境保护局）中建议的测试方案为例，介绍了为生成某种物质的毒性数据可能进行的测试。描述了用于生殖效应测试的方案和终点。其中包括急性、亚慢性、慢性和短期测试。对生殖风险评估的四个组成部分（危害识别、剂量反应评估、暴露评估和风险表征）进行了研究。以二溴氯丙烷对兔睾丸参数的影响为例，说明了进行生殖风险评估时可采用的方法。确定了在筛选方法、充分的剂量反应测试、毒代动力学、终点开发和外推方法等方面的研究需求。最后，本文讨论了预计生殖风险评估会发生变化的特定领域，以及影响这些变化的性质和程度的机制。
