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Related Concept Videos

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Framework for classifying chemicals for repeat dose toxicity using NAMs.

J E Doe1, P Botham2, D Holland3

  • 1School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Byrom Street, Liverpool, L3 3AF, UK.

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|May 24, 2025
PubMed
Summary
This summary is machine-generated.

A new classification system categorizes chemical toxicity using non-animal methods, assessing bioactivity and bioavailability. This framework helps classify chemicals into low, medium, or high concern levels for safer use.

Keywords:
Chemical safety assessmentClassification and labellingNew approach methodology (NAM)Next-generation safety assessmentRegulatory toxicologyRisk management

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Area of Science:

  • Toxicology and Chemical Safety
  • In Silico and In Vitro Toxicology
  • Regulatory Science

Background:

  • The EPAA's 'NAM Designathon 2023' aimed to develop a chemical classification system using non-animal methodologies.
  • Existing systems often rely on animal testing, necessitating alternative approaches for human toxicity assessment.
  • A tiered approach integrating multiple lines of evidence is crucial for robust chemical safety evaluations.

Purpose of the Study:

  • To develop and demonstrate a New Approach Methodologies (NAMs) based classification system for human systemic toxicity, focusing on repeat dose toxicity.
  • To categorize chemicals into three levels of concern: low, medium, and high, based on bioactivity and bioavailability.
  • To integrate in silico predictions, in vitro bioavailability and physiologically based kinetic (PBK) modeling, and in vitro bioactivity assays into a cohesive framework.

Main Methods:

  • Utilized in silico (Q)SAR models to predict toxicity endpoints and identify potential hazards.
  • Employed three toxicokinetic (TK) models to simulate 14-day plasma Cmax for bioavailability assessment.
  • Categorized bioactivity using a matrix based on potency (AC50 values) and severity of in vitro assay outcomes from ToxCast.

Main Results:

  • Successfully applied the developed framework to categorize 12 chemicals into three levels of concern (low, medium, high).
  • Demonstrated the feasibility of using a matrix approach integrating bioactivity and bioavailability for chemical classification.
  • The results align with the EPAA Designathon's goal of establishing a NAMs-based toxicity classification system.

Conclusions:

  • The proposed NAMs-based classification system effectively categorizes chemicals into different levels of concern for human systemic toxicity.
  • Further refinement is needed regarding the range of assays, framework categorization definitions, and integration into tiered assessment strategies.
  • The study highlights the potential of NAMs to support regulatory decision-making and reduce reliance on animal testing.