EUROTOX 2018 ControlCenter

Online Program Overview Session: EU-ToxRisk

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EU-ToxRisk: status quo of the Horizon2020 flagship project on non-animal toxicology

Session chair: Bob van de Water; Marcel Leist
 
Shortcut: EU-ToxRisk
Date: Sunday, 2 September, 2018, 13:00
Room: Meeting Studio 211/212
Session type: Others

Contents

EU-ToxRisk-1

EU-ToxRisk: status quo of the Horizon2020 flagship project on non-animal toxicology (#839)

G. Pallocca1

1 University of Konstanz, CAAT-Europe, Konstanz, Germany

EU-ToxRisk is the Horizon2020 flagship research project for new approach method (NAM)-based toxicity testing in Europe. The ultimate aim of the project is to develop human-relevant toxicity testing strategies that can be applied in a regulatory or screening context using only NAMs. NAMs include different approaches such as cell-based models, omic technologies, in silico and toxicokinetic modelling. They can be used to investigate key and intermediate steps leading to apical endpoints of toxicity. The adverse outcome pathway (AOP) concept paves the way towards a use of mechanistic toxicological data for regulatory applications. Nonetheless, the integration of NAM data into a risk assessment strategy is challenging, in particular for complex endpoints such as repeated dose toxicity (RDT) or developmental/reproductive toxicity (DART). In this session, we will provide an overview of the use of NAMs developed by the EU-ToxRisk programme, which cover systemic RDT in different target organs and DART toxicity areas. A focus will be set on read-across approaches and their application for risk assessment, also from an industry perspective. We will discuss about practical applications of AOPs for safety assessment. Examples for the use of physiology-based pharmacokinetic modelling (PBPK) to extrapolate NAM data to in vivo doses will be given. Finally, we will report on recent results coming from the application of high-content technologies (e.g. RNA-seq).

Program of the session

  • The EU-ToxRisk project: an update and future perspectives - Prof. Dr. Bob van de Water, Research Division of Drug Discovery and Safety, Leiden University, Leiden, The Netherlands
  • NAMs in EU-ToxRisk - Prof. Dr. Marcel Leist, In Vitro Toxicology and Biomedicine, Department inaugurated by the Doerenkamp-Zbinden Foundation, University of Konstanz, Konstanz, Germany
  • Industry perspective on NAMs - application in hazard assessment and read across - Dr. Hennicke Kamp, BASF SE, Experimental Toxicology and Ecology, Ludwigshafen, Germany
  • The EU-ToxRisk read-across strategy - Dr. Sylvia Escher, Fraunhofer Institute of Toxicology and Experimental Medicine (ITEM) Chemical Risk Assessment Group Manager Structure Activity Relationships/databases, and expert systems, Hannover, Germany
  • Physiologically based pharmacokinetics as part of an integrated approach to testing and assessment - Dr. Ciaran Fisher, Simcyp (A Certara Company), Sheffield, UK
  • Practical application of AOPs in chemical safety assessment: mitochondrial toxicity and agrochemicals - Prof. Dr. Bob van de Water, Research Division of Drug Discovery and Safety, Leiden University, Leiden, The Netherlands
  • RNA-Seq analysis of EU-ToxRisk cell models - Rajinder Gupta, Department of Toxicogenomics, GROW-School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, The Netherlands
Keywords: New approach methods (NAMs), adverse outcome pathway, repeated dose toxicity, developmental/reproductive toxicity, risk assessment