In Vitro Metabolism and Bioavailability Tests for Endocrine Active Substances: What is Needed Next for Regulatory Purposes?

Knowledge Source Identification
Knowledge source name In Vitro Metabolism and Bioavailability Tests for Endocrine Active Substances: What is Needed Next for Regulatory Purposes?
Owner/Developer Alternatives to Animal Experimentation
Abbreviated owner ALTEX
Country Switzerland
Languages English
URL http://altweb.jhsph.edu/altex/30_3/Jacobs.pdf
Description 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.
Knowledge Source Category
Category Publication
Sub categories Review / Research article
Knowledge Dissemination and Sharing
Dissemination channel Website, Printed
Targeted audience (specified/objective analysis) Scientists, Policy-makers, Regulators, Industry, Researchers, Students
Users access Open access
Knowledge Characterization
3Rs relevance Replacement, Reduction
Purpose Documentation and information, Regulatory testing
Legislative framework Food and feed legislation
Technology/Tools Alternative test methods (in vitro)