21st Century Approaches for Evaluating Exposures, Biological Activity, and Risks of Complex Substances: Workshop highlights

Ursula G. Sauer*, Robert A. Barter, Richard A. Becker, Emilio Benfenati, Elisabet Berggren, Bruno Hubesch, Heli M. Hollnagel, Kunifumi Inawaka, Athena M. Keene, Philipp Mayer, Kathleen Plotzke, Robert Skoglund, Océane Albert

*Corresponding author for this work

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Abstract

The June 2019 workshop 21st Century Approaches for Evaluating Exposures, Biological Activity, and Risks of Complex Substances, co-organised by the International Council of Chemical Association's Long-Range Research Initiative and the European Commission's Joint Research Centre, is summarised. Focus was the need for improved approaches to evaluate the safety of complex substances. Approximately 10% and 20% of substances registered under the EU chemicals legislation are ‘multi-constituent substances’ and ‘substances of unknown or variable compositions, complex reaction products and biological substances’ (UVCBs), respectively, and UVCBs comprise approximately 25% of the U.S. Toxic Substances Control Act Inventory. Workshop participants were asked to consider how the full promise of new approach methodologies (NAMs) could be brought to bear to evaluate complex substances. Sessions focused on using NAMs for screening, biological profiling, and in complex risk evaluations; improving read-across approaches employing new data streams; and methods to evaluate exposure and dosimetry. The workshop concluded with facilitated discussions to explore actionable steps forward. Given the diversity of complex substances, no single ‘correct’ approach was seen as workable. The path forward should focus on ‘learning by doing’ by developing and openly sharing NAM-based fit-for-purpose case examples for evaluating biological activity, exposures and risks of complex substances.

Original languageEnglish
Article number104583
JournalRegulatory Toxicology and Pharmacology
Volume111
Number of pages4
ISSN0273-2300
DOIs
Publication statusPublished - 2020

Keywords

  • Adverse outcome pathway (AOP)
  • Combined exposure
  • Exposure assessment
  • Integrated approach to testing and assessment (IATA)
  • Mode-of-action (MoA)
  • Multi-constituent substances
  • New approach methodologies (NAMs)
  • UVCBs (substances of unknown or variable compositions, complex reaction products and biological substances)

Cite this

Sauer, U. G., Barter, R. A., Becker, R. A., Benfenati, E., Berggren, E., Hubesch, B., Hollnagel, H. M., Inawaka, K., Keene, A. M., Mayer, P., Plotzke, K., Skoglund, R., & Albert, O. (2020). 21st Century Approaches for Evaluating Exposures, Biological Activity, and Risks of Complex Substances: Workshop highlights. Regulatory Toxicology and Pharmacology, 111, [104583]. https://doi.org/10.1016/j.yrtph.2020.104583