Category Research project
  • Expositionsschätzung

Implementing the EFSAshort forEuropean Food Safety Authority NAMs roadmap through advancing toxicokinetic knowledge in chemical risk assessment

Project status
In Progress
Project start
Apr 2023
Project end
Apr 2027
Acronym
ADME4NGRA
Department
Sicherheit von Pestiziden

Description and Objective

The EFSAshort forEuropean Food Safety Authority-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 BfRshort forGerman Federal Institute for Risk Assessment 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. BfRshort forGerman Federal Institute for Risk Assessment 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.
Type of project

Third-party funded project

Areas of research

Moderne Methoden in der Toxikologie / Gesundheit von Mensch, Tier und Umwelt (One Health)

Organisational units and partners

Lead unit: Prüf- und Bewertungsstrategien von Pestiziden (66)
Involved BfR partners: Sicherheit von Pestiziden
External partner: Fraunhofer-Institut für Toxikologie und Experimentelle Medizin, Free University Amsterdam, Wageningen University & Research, French Agency for Food, Environmental and Occupational Health & Safety , Italian National Institute of Health, Mario Negri Institute for Pharmacological Research, Rheinische Friedrich-Wilhelms-Universität Bonn

Funding body and grant number

Europäische Behörde für Lebensmittelsicherheit
OC/EFSAshort forEuropean Food Safety Authority/MESE/2022/04

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