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ICCVAM Biennial Report 2018-2019

Biennial Progress Report 2018-2019 Interagency Coordinating Committee on the Validation of Alternative Methods

Using ToxCast Data for Food Chemical Safety Risk Assessment

NAMs are currently being developed and evaluated for use in chemical safety risk assessment, including chemicals used in food. NAMs include in vitro HTS assays such as those used in ToxCast and Tox21. These assays have been run for thousands of compounds, including hundreds of compounds used in food. However, the relationship of these NAM data with traditional in vivo animal data and the utility of NAMs for risk assessment remain under evaluation. This study evaluated the utility of ToxCast/Tox21 HTS data in food safety risk assessment. To do this, bioactive concentrations of a subset of food-use compounds in ToxCast were converted to oral equivalent doses via IVIVE using either in vitro or in silico-based toxicokinetic parameters for a subset of food-use compounds. These oral equivalent doses were then compared to doses demonstrated to cause effects in in vivo animal tests using data compiled by EPA and FDA. Initial comparisons demonstrated great variability in the correlation between ToxCast and in vivo data, so steps are being taken to further refine the toxicokinetic information, chemical groups, and in vivo endpoints to identify additional information and conditions necessary to utilize HTS data for preliminary food safety assessment.