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RISK assessment of chemicals integrating HUman centric Next generation Testing strategies promoting the 3Rs (RISK-HUNT3R)


Funding programme / funding institution: Europäische Union

Grant number: 964537

Project homepage:

Project description:

The overall objective of RISK-HUNT3R is to provide a chemical safety testing framework for NGRA that meets regulatory needs, is fit-for-purpose, and is based on non-animal human-relevant test systems. RISK-HUNT3R will establish and systematically evaluate, optimize and align the NAM-based testing strategies five different NGRA assessment modules, in particular (i) exposure / bioavailability, (ii) toxicokinetics, (iii) toxicodynamics, (iv )adversity and (v) the integration of data to allow risk as well as uncertainty assessment. Thus, data will be provided that can be used for regulatory decision-making and to support an industrial setting for the design of non-hazardous substances. To provide a strong proof-of-concept for the applicability of NGRA approaches for chemical safety assessment, RISK-HUNT3R will focus on three critical areas of human health effects where an integrated testing strategy using animal-free approaches has not yet been systematically evaluated: i) Specific target organ toxicity (STOT) after single and repeated (chronic) exposure; ii) Developmental toxicity with a focus on developmental neurotoxicity (DNT); iii) Non-genotoxic carcinogenesis (NGC). We have defined five main workstreams related to the evaluation and optimization of the different NGRA assessment modules and the ultimate implementation of the NGRA strategy in an industry and regulatory setting. These workstreams address the following interrelated scientific objectives:

  1. Establishing a framework to link human exposure to concentrations of chemicals at their target sites
  2. Establishing a framework to identify candidate human relevant molecular initiation events (MIEs) and chemical-biological key events as the basis for NGRA.
  3. Implementing a strategy based on advanced human-relevant test systems to predict human adverse events.
  4. Creating integrated quantitative AOP (qAOP) and quantitative systems toxicology (QST) modelling approaches for chemical safety assessment in NGRA
  5. Disseminating an NGRA framework that is ready for implementation in industry and regulatory sectors.

Project partners

  • National Institute For Public Health and The Environment
  • Fraunhofer Institut für Toxikologie und Experimentelle Medizin
  • Uppsala Universitet
  • Certara
  • Universität Konstanz
  • Fundació Institut Mar d'Investigacions Mèdiques
  • Institut national de la santé et de la recherche médicale, FR
  • Liverpool John Moores University
  • Edelweiss Connect GmbH
  • European Molecular Biology Laboratory
  • DTU Fødevareinstituttet (National Food Institute) (Danmarks Tekniske Universitet, DK)
  • BioDetectionSystems
  • Steinbeis-Transferzentrum CAAT-Europe an der Universität Konstanz (Steinbeis GmbH & Co. KG für Technologietransfer)
  • Universiteit Leiden


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