View in EDS PDF Full Text

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

Saved in:
Bibliographic Details
Title: A Retrospective Performance Assessment of the Developmental Neurotoxicity Study in Support of OECD Test Guideline 426.
Authors: Makris, Susan L.1 makris.susan@epa.gov, Raffaele, Kathleen2, Allen, Sandra3, Bowers, Wayne J.4, Hass, Ulla5, Alleva, Enrico6, Calamandrei, Gemma6, Sheets, Larry7, Amcoff, Patric8, Delrue, Nathalie8, Crofton, Kevin M.9
Source: Environmental Health Perspectives. Jan2009, Vol. 117 Issue 1, p17-25. 9p. 4 Charts.
Subject Terms: Retrospective studies, Neurotoxicology, Children's health, Risk assessment, Adult education workshops
Geographic Terms: United States
Company/Entity: United States. Environmental Protection Agency
Abstract: 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. [ABSTRACT FROM AUTHOR]
Copyright of Environmental Health Perspectives is the property of National Institute of Environmental Health Sciences and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: GreenFILE
FullText Links:
  – Type: pdflink
Text:
  Availability: 0
Header DbId: 8gh
DbLabel: GreenFILE
An: 36162308
AccessLevel: 6
PubType: Academic Journal
PubTypeId: academicJournal
PreciseRelevancyScore: 0
IllustrationInfo
Items – Name: Title
  Label: Title
  Group: Ti
  Data: A Retrospective Performance Assessment of the Developmental Neurotoxicity Study in Support of OECD Test Guideline 426.
– Name: Author
  Label: Authors
  Group: Au
  Data: <searchLink fieldCode="AR" term="%22Makris%2C+Susan+L%2E%22">Makris, Susan L.</searchLink><relatesTo>1</relatesTo><i> makris.susan@epa.gov</i><br /><searchLink fieldCode="AR" term="%22Raffaele%2C+Kathleen%22">Raffaele, Kathleen</searchLink><relatesTo>2</relatesTo><br /><searchLink fieldCode="AR" term="%22Allen%2C+Sandra%22">Allen, Sandra</searchLink><relatesTo>3</relatesTo><br /><searchLink fieldCode="AR" term="%22Bowers%2C+Wayne+J%2E%22">Bowers, Wayne J.</searchLink><relatesTo>4</relatesTo><br /><searchLink fieldCode="AR" term="%22Hass%2C+Ulla%22">Hass, Ulla</searchLink><relatesTo>5</relatesTo><br /><searchLink fieldCode="AR" term="%22Alleva%2C+Enrico%22">Alleva, Enrico</searchLink><relatesTo>6</relatesTo><br /><searchLink fieldCode="AR" term="%22Calamandrei%2C+Gemma%22">Calamandrei, Gemma</searchLink><relatesTo>6</relatesTo><br /><searchLink fieldCode="AR" term="%22Sheets%2C+Larry%22">Sheets, Larry</searchLink><relatesTo>7</relatesTo><br /><searchLink fieldCode="AR" term="%22Amcoff%2C+Patric%22">Amcoff, Patric</searchLink><relatesTo>8</relatesTo><br /><searchLink fieldCode="AR" term="%22Delrue%2C+Nathalie%22">Delrue, Nathalie</searchLink><relatesTo>8</relatesTo><br /><searchLink fieldCode="AR" term="%22Crofton%2C+Kevin+M%2E%22">Crofton, Kevin M.</searchLink><relatesTo>9</relatesTo>
– Name: TitleSource
  Label: Source
  Group: Src
  Data: <searchLink fieldCode="JN" term="%22Environmental+Health+Perspectives%22">Environmental Health Perspectives</searchLink>. Jan2009, Vol. 117 Issue 1, p17-25. 9p. 4 Charts.
– Name: Subject
  Label: Subject Terms
  Group: Su
  Data: <searchLink fieldCode="DE" term="%22Retrospective+studies%22">Retrospective studies</searchLink><br /><searchLink fieldCode="DE" term="%22Neurotoxicology%22">Neurotoxicology</searchLink><br /><searchLink fieldCode="DE" term="%22Children's+health%22">Children's health</searchLink><br /><searchLink fieldCode="DE" term="%22Risk+assessment%22">Risk assessment</searchLink><br /><searchLink fieldCode="DE" term="%22Adult+education+workshops%22">Adult education workshops</searchLink>
– Name: SubjectGeographic
  Label: Geographic Terms
  Group: Su
  Data: <searchLink fieldCode="DE" term="%22United+States%22">United States</searchLink>
– Name: SubjectCompany
  Label: Company/Entity
  Group: Su
  Data: <searchLink fieldCode="DE" term="%22United+States%2E+Environmental+Protection+Agency%22">United States. Environmental Protection Agency</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: 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. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: <i>Copyright of Environmental Health Perspectives is the property of National Institute of Environmental Health Sciences and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=8gh&AN=36162308
RecordInfo BibRecord:
  BibEntity:
    Identifiers:
      – Type: doi
        Value: 10.1289/ehp.11447
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        PageCount: 9
        StartPage: 17
    Subjects:
      – SubjectFull: Retrospective studies
        Type: general
      – SubjectFull: Neurotoxicology
        Type: general
      – SubjectFull: Children's health
        Type: general
      – SubjectFull: Risk assessment
        Type: general
      – SubjectFull: Adult education workshops
        Type: general
      – SubjectFull: United States
        Type: general
      – SubjectFull: United States. Environmental Protection Agency
        Type: general
    Titles:
      – TitleFull: A Retrospective Performance Assessment of the Developmental Neurotoxicity Study in Support of OECD Test Guideline 426.
        Type: main
  BibRelationships:
    HasContributorRelationships:
      – PersonEntity:
          Name:
            NameFull: Makris, Susan L.
      – PersonEntity:
          Name:
            NameFull: Raffaele, Kathleen
      – PersonEntity:
          Name:
            NameFull: Allen, Sandra
      – PersonEntity:
          Name:
            NameFull: Bowers, Wayne J.
      – PersonEntity:
          Name:
            NameFull: Hass, Ulla
      – PersonEntity:
          Name:
            NameFull: Alleva, Enrico
      – PersonEntity:
          Name:
            NameFull: Calamandrei, Gemma
      – PersonEntity:
          Name:
            NameFull: Sheets, Larry
      – PersonEntity:
          Name:
            NameFull: Amcoff, Patric
      – PersonEntity:
          Name:
            NameFull: Delrue, Nathalie
      – PersonEntity:
          Name:
            NameFull: Crofton, Kevin M.
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 01
              M: 01
              Text: Jan2009
              Type: published
              Y: 2009
          Identifiers:
            – Type: issn-print
              Value: 00916765
          Numbering:
            – Type: volume
              Value: 117
            – Type: issue
              Value: 1
          Titles:
            – TitleFull: Environmental Health Perspectives
              Type: main
ResultId 1