Francis E Z
U.S. Environmental Protection Agency, Office of Research and Development, Washington, D.C. 20460.
Neurotoxicology. 1992 Spring;13(1):77-84.
A number of efforts, in the last 15 years, have been directed at developing protocols to assess the potential developmental neurotoxicity (DN) of test agents. Japan and the United Kingdom have general protocols that describe the behavioral parameters that should be evaluated as part of other types of testing protocols, such as standard developmental and/or reproductive toxicity studies. In 1986, EPA published a proposed separate guideline for the testing of glycol ethers. Since then, this protocol has undergone extensive review and comment by an agency-wide workgroup, participants of a workshop sponsored by EPA and NIDA, EPA's Scientific Advisory Panel, and the public. Comments were taken into consideration and the final DN testing protocol has been published recently by EPA's Office of Pesticide Programs. This protocol provides specific guidance on issues of study design, aspects of CNS function to be evaluated and criteria for selection of testing procedures. It is designed to be a "generic" protocol could be applied to testing of pesticides and other chemicals and that could be modified on a case-by-case basis depending on the data available on a specific agent of concern. With the development of testing protocols for assessing DN, there comes a need for the development of guidance as to how the data should be interpreted and applied toward conducting a risk assessment for extrapolation to humans. Some guidance was developed at the EPA-NIDA Workshop. EPA has published specific risk assessment guidelines in the area of developmental toxicity that include a section on interpretation of data on functional deficits, including DN.(ABSTRACT TRUNCATED AT 250 WORDS)
在过去15年里，人们做出了许多努力来制定评估受试物潜在发育神经毒性（DN）的方案。日本和英国有一般性方案，描述了作为其他类型测试方案（如标准发育和/或生殖毒性研究）一部分应评估的行为参数。1986年，美国环境保护局（EPA）发布了一份关于乙二醇醚测试的单独拟议指南。从那时起，该方案经过了一个全机构工作组、EPA和美国国家药物滥用研究所（NIDA）主办的研讨会参与者、EPA科学咨询小组以及公众的广泛审查和评论。所提意见均被考虑在内，最终的DN测试方案最近由EPA农药项目办公室发布。该方案就研究设计问题、要评估的中枢神经系统功能方面以及测试程序选择标准提供了具体指导。它旨在成为一个“通用”方案，可应用于农药和其他化学品的测试，并可根据有关特定受试物的现有数据逐案进行修改。随着评估DN测试方案的发展，需要就如何解释数据以及如何将其用于进行外推至人类的风险评估制定指导意见。EPA-NIDA研讨会上制定了一些指导意见。EPA已发布了发育毒性领域的具体风险评估指南，其中包括关于功能缺陷数据解释（包括DN）的一节。
