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Undertaking positive control studies as part of developmental neurotoxicity testing: a report from the ILSI Research

Kevin M Crofton1, John A Foss, Ulla Hass

  • 1Neurotoxicology Division, NHEERL, ORD, US EPA, Research Triangle Park, NC, USA. crofton.kevin@epa.gov

Neurotoxicology and Teratology
|August 8, 2007
PubMed

Insights

Positive control studies are essential for reliable developmental neurotoxicity (DNT) risk assessments. This review guides the selection and use of positive control agents to ensure accurate DNT testing and data interpretation.

Area of Science:

  • Toxicology
  • Neuroscience
  • Risk Assessment

Background:

  • Developmental neurotoxicity (DNT) testing requires robust positive control data.
  • Positive controls validate laboratory performance and the sensitivity of DNT assays.
  • These data support the biological significance of findings and confidence in negative results.

Purpose of the Study:

  • To provide a practical guide for selecting and using positive control agents in DNT studies.
  • To discuss the advantages and disadvantages of various positive control agents for DNT endpoints.
  • To offer recommendations for interpreting and reporting positive control data in DNT risk assessments.

Main Methods:

  • Review of existing literature on positive control agents in developmental neurotoxicology.
  • Analysis of advantages and disadvantages of different positive control agents for specific DNT endpoints.
  • Consideration of study design issues pertinent to positive control studies in DNT.

Main Results:

  • Positive control data are critical for evaluating laboratory capabilities in DNT testing.
  • They aid in determining the biological significance of observed effects and increase confidence in negative findings.
  • The review discusses agent selection based on DNT study endpoints and provides guidance on data interpretation.

Conclusions:

  • Positive control studies are an integral part of DNT testing and risk assessment.
  • Implementing standardized positive control studies enhances the reliability and validity of DNT data.
  • Laboratories generating data for risk decisions should incorporate positive control studies into their DNT testing protocols.

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