In Vitro Metabolism and Bioavailability Tests for Endocrine Active Substances: What is Needed Next for Regulatory Purposes?
Owner/Developer: Alternatives to Animal Experimentation (ALTEX)
Legislation and prospective legislative proposals internationally (may) require that chemicals be tested for their ability to disrupt the hormonal systems of mammals. Chemicals found to test positive in vitro are considered to be endocrine active substances (EAS) and may be putative endocrine disruptors (EDs) in vivo. While there is a growing body of international in vitro test guidelines addressing EAS mechanisms and modes of action, to date there are still few or no standardized methods to incorporate metabolic and toxicokinetic aspects into these in vitro tests for EAS. [...] The complexity of in vivo metabolism presents major challenges for the development of predictive models suitable for the extrapolation of data from in silico/in vitro approaches to models that can occur in vivo. Therefore, the long-term recommendations are intended to foster an international harmonization of databases, delineation of metabolic pathways, and development of predictive tools that will provide a fundamental understanding of the processes by which metabolism occurs, increasing the predictive accuracy of in silico/in vitro methods.
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