A Retrospective Performance Assessment of the Developmental Neurotoxicity Study in Support of OECD Test Guideline 426

Susan L. Makris, Kathleen Raffaele, Sandra Allen, Wayne J. Bowers, Ulla Hass, Enrico Alleva, Gemma Calamandrei, Larry Sheets, Patric Amcoff, Nathalie Delrue, Kevin M. Crofton

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Abstract

OBJECTIVE: We conducted a review of the history and performance of developmental neurotoxicity mic (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.
Original languageEnglish
JournalEnvironmental Health Perspectives
Volume117
Issue number1
Pages (from-to)17-25
ISSN0091-6765
DOIs
Publication statusPublished - 2009

Keywords

  • children's health
  • Organisation of Economic Co-operation and Development
  • developmental neurotoxicity
  • guideline
  • risk assessment
  • hazard assessment
  • US Environmental Protection Agency

Cite this

Makris, Susan L. ; Raffaele, Kathleen ; Allen, Sandra ; Bowers, Wayne J. ; Hass, Ulla ; Alleva, Enrico ; Calamandrei, Gemma ; Sheets, Larry ; Amcoff, Patric ; Delrue, Nathalie ; Crofton, Kevin M. / A Retrospective Performance Assessment of the Developmental Neurotoxicity Study in Support of OECD Test Guideline 426. In: Environmental Health Perspectives. 2009 ; Vol. 117, No. 1. pp. 17-25.
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abstract = "OBJECTIVE: We conducted a review of the history and performance of developmental neurotoxicity mic (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.",
keywords = "children's health, Organisation of Economic Co-operation and Development, developmental neurotoxicity, guideline, risk assessment, hazard assessment, US Environmental Protection Agency",
author = "Makris, {Susan L.} and Kathleen Raffaele and Sandra Allen and Bowers, {Wayne J.} and Ulla Hass and Enrico Alleva and Gemma Calamandrei and Larry Sheets and Patric Amcoff and Nathalie Delrue and Crofton, {Kevin M.}",
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Makris, SL, Raffaele, K, Allen, S, Bowers, WJ, Hass, U, Alleva, E, Calamandrei, G, Sheets, L, Amcoff, P, Delrue, N & Crofton, KM 2009, 'A Retrospective Performance Assessment of the Developmental Neurotoxicity Study in Support of OECD Test Guideline 426', Environmental Health Perspectives, vol. 117, no. 1, pp. 17-25. https://doi.org/10.1289/ehp.11447

A Retrospective Performance Assessment of the Developmental Neurotoxicity Study in Support of OECD Test Guideline 426. / Makris, Susan L.; Raffaele, Kathleen; Allen, Sandra; Bowers, Wayne J.; Hass, Ulla; Alleva, Enrico; Calamandrei, Gemma; Sheets, Larry; Amcoff, Patric; Delrue, Nathalie; Crofton, Kevin M.

In: Environmental Health Perspectives, Vol. 117, No. 1, 2009, p. 17-25.

Research output: Contribution to journalJournal articleResearchpeer-review

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T1 - A Retrospective Performance Assessment of the Developmental Neurotoxicity Study in Support of OECD Test Guideline 426

AU - Makris, Susan L.

AU - Raffaele, Kathleen

AU - Allen, Sandra

AU - Bowers, Wayne J.

AU - Hass, Ulla

AU - Alleva, Enrico

AU - Calamandrei, Gemma

AU - Sheets, Larry

AU - Amcoff, Patric

AU - Delrue, Nathalie

AU - Crofton, Kevin M.

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N2 - OBJECTIVE: We conducted a review of the history and performance of developmental neurotoxicity mic (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.

AB - OBJECTIVE: We conducted a review of the history and performance of developmental neurotoxicity mic (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.

KW - children's health

KW - Organisation of Economic Co-operation and Development

KW - developmental neurotoxicity

KW - guideline

KW - risk assessment

KW - hazard assessment

KW - US Environmental Protection Agency

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DO - 10.1289/ehp.11447

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VL - 117

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JO - Environmental Health Perspectives

JF - Environmental Health Perspectives

SN - 0091-6765

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ER -