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ADME4NGRA: Implementing the EFSA NAMs roadmap through advancing toxicokinetic knowledge in chemical risk assessment


Funding programme / funding institution: Europäische Behörde für Lebensmittelsicherheit (EFSA) - Italien

Grant number: OC/EFSA/MESE/2022/04

Project homepage: -

Project description:

The EFSA-funded project will investigate whether data obtained by using novel in vitro methods are suitable to feed computer-based predictive models for the estimation of toxicological effects in vivo (a so-called quantitative in vitro to in vivo extrapolation (QIVIVE)). For this purpose, the in vitro models are evaluated with respect to their absorption, distribution, metabolism and excretion potential (ADME) of food ingredients and contaminants. In this context, the project addresses three research objectives: 1. comparison of ADME processes between humans and rats using 'advanced' in vitro systems 2. development and application of advanced in silico models and databases for the depiction of ADME processes 3. integration of QIVIVE and PBK (Physiologically Based Kinetic) models into risk assessment for humans - from model development to case studies One focus of the work at BfR will be the investigation of ADME processes in the liver using human and murine in vitro liver systems. This will include kinetic parameters, isoform-specific metabolism, phase I & II metabolism and transport of chemicals as general liver-specific excretion. In the past, risk assessment has neglected the metabolic capacity of the microbiome. Therefore, microbial metabolites of relevant chemicals from gut microbiome cultures will now be identified by mass spectrometry (MS) and their genotoxicity assessed. Finally, the generated in vitro data will be implemented into the PBK models. BfR will collaborate on the calibration and evaluation of PBK-based QIVIVE models to characterize the toxicological hazard of chemicals for use in future risk assessment strategies.

Coordination: Fraunhofer-Institut für Toxikologie und Experimentelle Medizin

Project partners:

  • Fraunhofer-Institut für Toxikologie und Experimentelle Medizin (ITEM), DE
  • Free University Amsterdam (VUA), NL
  • Wageningen University & Research (WUR), NL
  • French Agency for Food, Environmental and Occupational Health & Safety (ANSES), FR
  • Italian National Institute of Health (ISS), IT
  • Mario Negri Institute for Pharmacological Research, IT
  • Rheinische Friedrich-Wilhelms-Universität Bonn, DE




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