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Evaluating opportunities for advancing the use of alternative methods in risk assessment through the development of fit-for-purpose in vitro assays. | LitMetric

AI Article Synopsis

  • The regulatory and scientific landscape is shifting towards a structured approach for chemical safety, utilizing high-throughput screening for initial assessments and more detailed tests for selected "hit chemicals."
  • There is currently a lack of effective in vitro alternatives for assessing most types of organ toxicities, which are critical for regulatory decisions.
  • The review highlights the need for advanced, biologically relevant cell-based assays to improve the prediction of safety and identifies specific research areas, particularly in developing a reliable lung toxicity test for volatile compounds.

Article Abstract

An evolving regulatory, scientific, and legislative landscape is driving a fundamental change in how chemical safety decisions are made. As we move to implement changes, regulatory agencies and industry are beginning to adopt tiered approaches, which leverage high-throughput screening technologies for prioritization and read across, followed by interrogation of "hit chemicals" with more rigorous dose-response assessment either in fit-for-purpose human cell-based assays or with traditional in vivo tests. However, to date, suitable in vitro alternatives do not exist for the vast majority of the organ toxicities that form the basis of current regulatory decisions. To successfully support safety decisions, biologically relevant, quantitative, cell-based assays that evaluate dose-response and identify regions of safety for chemical exposure are required. This review evaluates the current state of the science in the development of such assays, identifies key gaps in the current tests, and recommends areas where research efforts may be focused to help move the risk assessment community towards more wide-spread use of in vitro methods. Our analysis suggests that a key shortcoming in the current efforts is the ability to test volatile compounds and to predict pulmonary toxicity. We present a mechanistically-based path forward for the development of a fit-for-purpose lung toxicity assay.

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Source
http://dx.doi.org/10.1016/j.tiv.2018.01.027DOI Listing

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