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Retrospective performance assessment of the draft test guideline 426 on developmental neurotoxicity.
Citation:
International Programme on Chemical Safety, World Health Org., Geneva, Switzerla, S. MAKRIS, K. RAFFAELE, S. Allen, W. Bowers, U. Hass, E. Alleva, G. Calamandra, L. Sheets, P. Amcoff, N. Delrue, AND K. M. CROFTON. Retrospective performance assessment of the draft test guideline 426 on developmental neurotoxicity. International Journal of Andrology. Blackwell Publishing, Malden, MA, 117(1):17-25, (2009).
Impact/Purpose:
The purpose and intent of this retrospective performance assessment document is to review the history of the developmental neurotoxicity (DNT) test method, and to demonstrate the extensive scientific efforts, including basic neurotoxicology research, inter-laboratory collaborative studies, expert workshops and validation studies, which form the foundation for this testing paradigm
Description:
This document was created by an international panel under the auspices of the International Programme on Chemical Safety of the World Health Programme. The purpose and intent of this retrospective performance assessment document is to review the history of the developmental neurotoxicity (DNT) test method, and to demonstrate the extensive scientific efforts, including basic neurotoxicology research, inter-laboratory collaborative studies, expert workshops and validation studies, which form the foundation for this testing paradigm. The relevance, applicability and use of the DNT study in human health risk assessment is also reviewed. These considerations address the historical performance of the DNT study, in support of developing an OECD DNT Test Guideline (TG 426), that satisfies current OECD validation criteria. This document provides the scientific basis for the international validation of developmental neurotoxicity testing using TG 426.
