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Exposure considerations in human safety assessment: Report from an EPAA Partners' Forum
Mark T D Cronin1, Nicholas Ball2, Sonja Beken3
1School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Byrom Street, Liverpool, L3 3AF, United Kingdom.
Regulatory Toxicology and Pharmacology : RTP
|August 28, 2023
Summary
Estimating substance exposure is crucial for safe chemical use. The European Partnership for Alternative Approaches to Animal Testing (EPAA) identified opportunities to improve exposure assessment for human safety and regulatory needs.
Area of Science:
- Chemical safety assessment
- Toxicology
- Risk assessment
Background:
- Accurate substance exposure estimation is fundamental for safe industrial product manufacturing and use.
- Current exposure assessment methods are driven by potential use and regulatory requirements, with room for optimization.
- The European Partnership for Alternative Approaches to Animal Testing (EPAA) convened a forum to address these challenges.
Purpose of the Study:
- To explore exposure considerations in human safety assessment of industrial products.
- To agree on key conclusions for the regulatory acceptance of exposure assessment approaches.
- To identify priority areas for further research investment in exposure science.
Main Methods:
- Convening a Partners' Forum (PF) involving various industrial sectors.
- Facilitating discussions on current exposure assessment practices and challenges.
- Identifying synergies and areas for collaboration across different industrial sectors.
Main Results:
- Recognition of the widespread use of exposure information across industrial sectors.
- Acknowledgement of the potential for creating synergies between different sectors in exposure assessment.
- Identification of specific research needs and collaboration opportunities.
Conclusions:
- The EPAA can significantly promote the use of exposure data in human safety assessment.
- Addressing specific regulatory needs requires optimized exposure assessment approaches.
- Collaboration and further research investment are crucial for advancing exposure science and ensuring chemical safety.
Keywords:
Chemicals legislationExposure-based frameworksIn silicoIn vitroNew approach methodologiesSafety assessmentMore Related Videos
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