Exposure considerations in human safety assessment: Report from an EPAA Partners' Forum

Regul Toxicol Pharmacol. 2023 Oct:144:105483. doi: 10.1016/j.yrtph.2023.105483. Epub 2023 Aug 26.

Abstract

Understanding and estimating the exposure to a substance is one of the fundamental requirements for safe manufacture and use. Many approaches are taken to determine exposure to substances, mainly driven by potential use and regulatory need. There are many opportunities to improve and optimise the use of exposure information for chemical safety. The European Partnership for Alternative Approaches to Animal Testing (EPAA) therefore convened a Partners' Forum (PF) to explore exposure considerations in human safety assessment of industrial products to agree key conclusions for the regulatory acceptance of exposure assessment approaches and priority areas for further research investment. The PF recognised the widescale use of exposure information across industrial sectors with the possibilities of creating synergies between different sectors. Further, the PF acknowledged that the EPAA could make a significant contribution to promote the use of exposure data in human safety assessment, with an aim to address specific regulatory needs. To achieve this, research needs, as well as synergies and areas for potential collaboration across sectors, were identified.

Keywords: Chemicals legislation; Exposure-based frameworks; In silico; In vitro; New approach methodologies; Safety assessment.

MeSH terms

  • Animal Testing Alternatives*
  • Animals
  • Commerce
  • Humans
  • Industry*
  • Risk Assessment