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Identification and Characterization of Adverse Effects in 21st Century Toxicology
Citation:
Keller, D. A., D. R. Juberg, N. Catlin, W. H. Farland, F. G. Hess, D. WOLF, AND N. G. Doerrer. Identification and Characterization of Adverse Effects in 21st Century Toxicology. TOXICOLOGICAL SCIENCES. Society of Toxicology, RESTON, VA, 126(2):291-297, (2012).
Impact/Purpose:
The workshop defined areas of research and analysis that will be needed to successfully use data developed from high-content, screening tools in a risk assessment paradigm that is based on characterization of adverse effects.
Description:
The ILSI Health and Environmental Sciences Institute Project Committee on Distinguishing Adverse from Non-Adverse / Adaptive Effects held a workshop in May 2011 to discuss approaches to identifying adverse effects in the context of the 2007 NRC committee report titled “Toxicity Testing in the 21st Century.” At the workshop, scientists from industry, government, academic, and non-governmental organizations discussed case studies and questions regarding how data from new, high-content assays developed for screening can be used to identify adverse effects. This paper conveys the major points from discussions at the workshop, as well as from HESI committee meetings held the previous two years. In summary, future assessments will: (1) use in vitro and in silico data to predict later-occurring apical endpoints, (2) be based on Relevant Pathways of Toxicological Concern (RPTCs), (3) require a systematic effort to characterize the RPTCs, (4) evaluate toxicological responses on a time and dose-response continuum, and (5) need to describe the context of the responses for determining the correct point of concern or point of departure. For risk assessment and regulatory decision-making purposes, a framework will be useful for systematically analyzing data to distinguish adverse changes from those that are adaptive or not adverse. The workshop defined areas of research and analysis that will be needed to successfully use data developed from high-content, screening tools in a risk assessment paradigm that is based on characterization of adverse effects.