TY - JOUR
T1 - 21st Century Approaches for Evaluating Exposures, Biological Activity, and Risks of Complex Substances
T2 - Workshop highlights
AU - Sauer, Ursula G.
AU - Barter, Robert A.
AU - Becker, Richard A.
AU - Benfenati, Emilio
AU - Berggren, Elisabet
AU - Hubesch, Bruno
AU - Hollnagel, Heli M.
AU - Inawaka, Kunifumi
AU - Keene, Athena M.
AU - Mayer, Philipp
AU - Plotzke, Kathleen
AU - Skoglund, Robert
AU - Albert, Océane
PY - 2020
Y1 - 2020
N2 - 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.
AB - 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.
KW - Adverse outcome pathway (AOP)
KW - Combined exposure
KW - Exposure assessment
KW - Integrated approach to testing and assessment (IATA)
KW - Mode-of-action (MoA)
KW - Multi-constituent substances
KW - New approach methodologies (NAMs)
KW - UVCBs (substances of unknown or variable compositions, complex reaction products and biological substances)
U2 - 10.1016/j.yrtph.2020.104583
DO - 10.1016/j.yrtph.2020.104583
M3 - Journal article
C2 - 31935484
AN - SCOPUS:85078132462
SN - 0273-2300
VL - 111
JO - Regulatory Toxicology and Pharmacology
JF - Regulatory Toxicology and Pharmacology
M1 - 104583
ER -