UVCB risk assessment framework: Substance identity and characterization considerations

S.E. Deglin, M.R. Embry, J. Arey, M. Fernandez, R. Hoke, J. de Knecht, K. Jenner, Mark Lampi, E. Leinala, Matthew MacLeod, Philipp Mayer, D. Salvito

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Abstract

Assessing the risks associated with substances of Unknown or Variable Composition, Complex Reaction Products, and Biological Materials (UVCBs) presents numerous challenges. International regulatory pro¬grams have highlighted the complexities of UVCB fate and exposure characterization, risk assessment, and registration. As such, this work aimed to develop approaches for assessing the ecological risks of UVCBs to meet regulatory needs. As an initial step, a framework was developed for grouping UVCB substances according to chemical and/or functional classes, exposure and use patterns, production volume, potential toxicity and other criteria. This ongoing effort will provide a better understanding of the nature of these substances and their sector of use, as well as insight into which UVCB classes may present the most significant challenges for testing and assessment. Additionally, a tiered approach to substance identification and characterization was developed to provide guidance on the minimum amount of information needed for a confident, risk-based assessment. The first step of this approach (Tier 0) relies on basic and readily available information. For example, Tier 0 substance identity and characterization information includes substance specifications, QA data, and basic chromatographic and/or elemental analyses. Tier 0 exposure and hazard information were also considered in the development of the Tier 0 substance identification and characterization information to ensure it would work towards an overall risk assessment framework. This work presents an initial effort to determine the minimum level of substance identity information required to perform a robust and fit-for-purpose ecological risk assessment for UVCB substances, along with criteria that could be used in a weight of evidence approach for substance identification and characterization, and exposure assessment. Examples are presented of UVCB mapping and classification as well as application of the tiered approach for substance characterization for risk assessment purposes. The results are anticipated to help streamline the data gather¬ing and testing requirements for the risk assessment. [The views of the authors of this presentation are those of the authors and do not represent the views of their respective organizations]

Original languageEnglish
Title of host publicationSociety of Environmental Toxicology and Chemistry North America 40th Annual Meeting - abstract book
PublisherSociety of Environmental Toxicology and Chemistry
Publication date2019
Pages61-61
Publication statusPublished - 2019
EventSociety of Environmental Toxicology and Chemistry North America 40th Annual Meeting - Toronto, Canada
Duration: 3 Nov 20197 Nov 2019
Conference number: 40

Conference

ConferenceSociety of Environmental Toxicology and Chemistry North America 40th Annual Meeting
Number40
CountryCanada
CityToronto
Period03/11/201907/11/2019
SeriesAnnual Meeting
ISSN1087-8939

Cite this

Deglin, S. E., Embry, M. R., Arey, J., Fernandez, M., Hoke, R., de Knecht, J., Jenner, K., Lampi, M., Leinala, E., MacLeod, M., Mayer, P., & Salvito, D. (2019). UVCB risk assessment framework: Substance identity and characterization considerations. In Society of Environmental Toxicology and Chemistry North America 40th Annual Meeting - abstract book (pp. 61-61). Society of Environmental Toxicology and Chemistry. Annual Meeting