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New approaches using adverse outcome pathways (AOPs) can improve developmental neurotoxicity (DNT) risk assessment by aligning testing with regulatory needs. This strategy aids in developing predictive integrated testing strategies for DNT compounds.

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Area of Science:

  • Toxicology
  • Neuroscience
  • Regulatory Science

Background:

  • Developmental neurotoxicity (DNT) risk assessment faces challenges due to limited toxicological data for many compounds.
  • New testing approaches are crucial for generating sufficient data to support regulatory decisions.
  • The International STakeholder NETwork (ISTNET) aims to align assay development with regulatory needs in DNT testing.

Purpose of the Study:

  • To explore the application of the adverse outcome pathway (AOP) concept for practical DNT testing.
  • To identify AOPs as tools for developing test systems that meet regulatory requirements.
  • To guide the development of predictive integrated testing strategies (ITSs) for DNT.

Main Methods:

  • The first ISTNET meeting focused on the AOP concept for DNT testing.
  • Recommendations for a roadmap towards AOP-based DNT testing were developed.
  • A stepwise approach using incomplete AOPs for compound grouping and focusing on key neurodevelopmental events was proposed.

Main Results:

  • AOPs are considered promising for promoting test system development aligned with regulatory needs.
  • The AOP concept is a key principle for assembling predictive ITSs for DNT.
  • A roadmap for AOP-based DNT testing involves using case studies and AOP intersections for assay development.

Conclusions:

  • AOPs offer a framework for advancing DNT testing strategies.
  • Future work includes quantitative network modeling and economic development of screening assays.
  • The transition from qualitative to quantitative approaches in AOP-based DNT testing is essential.