Improving the Environmental Risk Assessment of Substances of Unknown or Variable Composition, Complex Reaction Products, or Biological Materials

Daniel Salvito, Marc Fernandez, Karen Jenner, Delina Y. Lyon, Joop de Knecht, Philipp Mayer, Matthew MacLeod, Karen Eisenreich, Pim Leonards, Romanas Cesnaitis, Miriam León-Paumen, Michelle Embry, Sandrine E. Déglin*

*Corresponding author for this work

Research output: Contribution to journalReviewResearchpeer-review

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Abstract

Substances of unknown or variable composition, complex reaction products, or biological materials (UVCBs) pose unique risk assessment challenges to regulators and to product registrants. These substances can contain many constituents, sometimes partially unknown and/or variable, depending on fluctuations in their source material and/or manufacturing process. International regulatory agencies have highlighted the difficulties in characterizing UVCBs and assessing their toxicity and environmental fate. Several industrial sectors have attempted to address these issues by developing frameworks and characterization methods. Based on the output of a 2016 workshop, this critical review examines current practices for UVCB risk assessment and reveals a need for a multipronged and transparent approach integrating whole-substance and constituent-based information. In silico tools or empirical measurements can provide information on discrete and/or blocks of UVCB constituents with similar hazard properties. Read-across and/or whole-substance toxicity and fate testing using adapted emerging methods can provide whole-substance information. Continued collaboration of stakeholders representing government, industry, and academia will facilitate the development of practical testing strategies and guidelines for addressing regulatory requirements for UVCBs. Environ Toxicol Chem 2020;00:1–12.

Original languageEnglish
JournalEnvironmental Toxicology and Chemistry
Volume39
Issue number11
Pages (from-to)2097-2108
ISSN0730-7268
DOIs
Publication statusPublished - 2020

Keywords

  • Complex substances
  • Ecological risk assessment
  • Mixtures
  • Risk assessment
  • UVCB

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