State of the science on assessing developmental neurotoxicity using new approach methods

Area of Science:

• Toxicology
• Neuroscience
• Regulatory Science

Background:

• The developing human brain is highly vulnerable to toxic exposures.
• Traditional in vivo testing for developmental neurotoxicity (DNT) faces ethical and efficiency challenges.
• New Approach Methods (NAMs) offer potential alternatives to traditional DNT testing.

Purpose of the Study:

• To explore the transition from traditional in vivo DNT tests to NAMs.
• To assess the current state of science regarding DNT NAMs.
• To identify challenges and next steps in advancing DNT NAMs.

Main Methods:

• Workshop convened experts from international organizations, government, industry, and academia.
• Discussions focused on various NAMs including in silico, in chemico, in vitro, and whole-organism approaches.
• Presentations and panel discussions provided an overview of DNT NAM capabilities and limitations.

Main Results:

• NAMs show promise for more ethical, economical, and scientifically robust DNT assessment.
• Progress in DNT NAMs was discussed alongside challenges in replicating complex neurodevelopmental biology.
• Integration of DNT NAMs into regulatory frameworks remains an ongoing discussion.

Conclusions:

• Advancing DNT testing requires continued development and validation of NAMs.
• Addressing challenges in biological complexity and regulatory acceptance is crucial.
• Collaboration among stakeholders is essential for the successful implementation of DNT NAMs.