Today's mechanistic toxicology is effectively relying to large extend on methodologies which substitute or complement traditional animal tests. The biotechnology and informatics revolution of the last decades has made such technologies broadly available and useful. In the US, especially the NAS vision report for a toxicology in the 21st century and its most recent adaptation by EPA for their toxicity testing strategy have initiated a debate how to create a novel approach based on human cell cultures, lower species, high-throughput testing and modeling. A systematic mapping of the entirety of pathways of toxicity, the Human Toxome, has been started. The lecture summarizes the lessons learned from the development, validation and acceptance of alternative methods for the creation of a new approach for regulatory toxicology. Beside the technical development of new approaches, a case is made that we need both conceptual steering, an objective assessment of current practices by evidence-based toxicology (modeled on Evidence-based Medicine) and implementation into legislation.

Mapping the human toxome for new regulatory tools

244th National Meeting (2012)

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