Modern methodologies and tools for human hazard assessment of chemicals


European Food Safety Authority
EFSA Journal
EFSA Journal 2014;12(4):3638 [87 pp.].

EFSA wishes to thank EFSA staff: Jean Lou Dorne, Andrea Altieri, Camille Bechaux, Charlotte Bergkvist, Arianna Chiusolo, Gina Cioacata, Andrea Germini, Georges Kass, Anna Maria Rossi, Andrea Terron, Matthew Watts and the staff of the Joint Research Centre of the European Commission: Claude Guillou, Alicia Paini and Andrew Worth for the contribution and support provided to this scientific output and Claude Lambré for reviewing the report, and the Scientific Committee, particularly Jan Alexander, Diane Benford, Qasim Chaudhry and Joseph Schlatter, for reviewing the report and providing comments.

Scientific Report of EFSA
On request from
Question Number
31 March 2014
Published in the EFSA Journal
24 April 2014
Last Updated
11 July 2014. This version replaces the previous one/s.
European Food Safety Authority (EFSA) Parma Italy

This scientific report provides a review of modern methodologies and tools to depict toxicokinetic and toxicodynamic processes and their application for the human hazard assessment of chemicals. The application of these methods is illustrated with examples drawn from the literature and international efforts in the field. First, the concepts of mode of action/adverse outcome pathway are discussed together with their associated terminology and recent international developments dealing with human hazard assessment of chemicals. Then modern methodologies and tools are presented including in vitro systems, physiologically-based models, in silico tools and OMICs technologies at the level of DNA/RNA (transcriptomics), proteins (proteomics) and the whole metabolome (metabolomics). Future perspectives for the potential applications of these modern methodologies and tools in the context of prioritisation of chemicals, integrated test strategies and the future of risk assessment are discussed. The report concludes with recommendations for future work and research formulated from consultations of EFSA staff, expert Panels and other international organisations.

mode of action, adverse outcome pathway, integrated testing strategy, physiologically-based models, in silico, OMICs
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