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  • 标题:A Retrospective Performance Assessment of the Developmental Neurotoxicity Study in Support of OECD Test Guideline 426
  • 作者:Susan L. Makris ; Kathleen Raffaele ; Sandra Allen
  • 期刊名称:Environmental Health Perspectives
  • 印刷版ISSN:0091-6765
  • 电子版ISSN:1552-9924
  • 出版年度:2009
  • 卷号:117
  • 期号:1
  • 页码:17-25
  • DOI:10.1289/ehp.11447
  • 语种:English
  • 出版社:OCR Subscription Services Inc
  • 摘要:Objective We conducted a review of the history and performance of developmental neurotoxicity (DNT) testing in support of the finalization and implementation of Organisation of Economic Co-operation and Development (OECD) DNT test guideline 426 (TG 426). Information sources and analysis In this review we summarize extensive scientific efforts that form the foundation for this testing paradigm, including basic neurotoxicology research, interlaboratory collaborative studies, expert workshops, and validation studies, and we address the relevance, applicability, and use of the DNT study in risk assessment. Conclusions The OECD DNT guideline represents the best available science for assessing the potential for DNT in human health risk assessment, and data generated with this protocol are relevant and reliable for the assessment of these end points. The test methods used have been subjected to an extensive history of international validation, peer review, and evaluation, which is contained in the public record. The reproducibility, reliability, and sensitivity of these methods have been demonstrated, using a wide variety of test substances, in accordance with OECD guidance on the validation and international acceptance of new or updated test methods for hazard characterization. Multiple independent, expert scientific peer reviews affirm these conclusions.
  • 关键词:children’s health; developmental neurotoxicity; guideline; hazard assessment; Organisation of Economic Co-operation and Development; risk assessment; U.S. Environmental Protection Agency
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