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CAAT Joins EU-ToxRisk: An Integrated European “Flagship” Program Driving Mechanism-based Toxicity Testing and Risk Assessment for the 21st Century

In a large H2020-supported collaborative project, academia joins forces with small and medium-sized enterprises (SMEs), large industry, contract research organizations (CROs), and regulatory bodies to achieve a paradigm shift in toxicology towards a more efficient and animal-free chemical safety assessment.

The Centers for Animal Testing at the Johns Hopkins Bloomberg School of Public Health and the University of Konstanz have joined an international consortium of 39 partner organizations that will be funded by the European Commission to work on the integration of new concepts for regulatory chemical safety assessment. These new concepts involve cutting-edge human-relevant in vitro non-animal methods and in silico computational technologies to translate molecular mechanistic understanding of toxicity into safety testing strategies with the ultimate goal of delivering reliable, animal-free hazard and risk assessment of chemicals.

Coordinated by Bob van de Water, Professor of Toxicology at the University Leiden (The Netherlands), EU-ToxRisk has the ambition to become the flagship in Europe for animal-free chemical safety assessment. The project will integrate advancements in cell biology, omics technologies, systems biology, and computational modelling to define the complex chains of events that link chemical exposure to toxic outcome. The consortium will provide proof of concept for a new mechanism-based chemical safety testing strategy with a focus on repeated-dose systemic toxicity as well as developmental and reproductive toxicity. Importantly, novel mechanism-based test methods will be integrated in fit-for-purpose testing batteries that are in line with the regulatory framework and will meet industrial implementation. EU-ToxRisk will develop new ab initio quantitative risk assessment approaches based on understanding of so-called “Adverse Outcome Pathways” (AOPs) incorporating all mechanistic toxicity data available in the public domain. It will also achieve a rapid improvement of so-called “read-across” approaches as the most important data-gap filling and hence animal-saving alternative method at present. Thus, the project strives towards faster safety evaluation of the many chemicals used by industry and the society.

Dr. Susanne Hougaard Bennekou from the Danish Environmental Protection Agency explained: “Safety evaluation is largely based on animal testing. This is the best we have today. However, there are widely recognised limitations, these being that the sensitivity and specificity of animal-based safety testing could lead to wrong predictions of chemical-induced human adversities. Whilst false-negative results compromise human safety, false-positive animal tests and the use of unnecessarily large safety factors may lead to the loss of beneficial and safe chemicals and drugs.” Professor Marcel Leist, head of the Center for Alternatives to Animal Testing in Europe (CAAT-Europe) in Konstanz, Germany, added: “Ethical issues related to the use of experimental animals as well as economic considerations (high costs, time delay by testing) demand a paradigm shift, away from ‘black box’ animal testing towards a toxicological assessment based on responses observed in human cells and a comprehensive mechanistic understanding of cause-consequence relationships of adverse chemical effects.”

EU-ToxRisk builds on testing strategies and knowledge developed in previous national and European projects, including the SEURAT-1 program, a cluster of seven projects in the field of animal-free safety assessment  (www.seurat-1.eu). The EU-ToxRisk consortium includes many of Europe’s leading toxicologists and experts in related fields such as cell and developmental biology, genomics, computational biology, cheminformatics, bioinformatics, biostatistics, and regulatory sciences. This breadth of expertise will allow EU-ToxRisk to develop efficient and innovative safety testing strategies, covering the whole range of stakeholders, to ensure fit-for-purpose solutions, practical routine applicability, and quick uptake of results. EU-ToxRisk will establish strong ties with the European Union Reference Laboratory for alternatives to animal testing (EURL-ECVAM), hosted by the Joint Research Centre (JRC), Institute for Health and Consumer Protection, to establish novel alternative testing strategies that are fit for regulatory purposes. In addition, the project will strongly collaborate with ongoing safety and risk assessment initiatives across the globe, including the Tox21 initiative in the United States.

Dr. Rob Taalman, Science and Research Director at Cosmetics Europe, the Brussels-based Personal Care Association, which co-funded with the European Commission the SEURAT-1 cluster, said: “We are thrilled to be part of this strategic EU project. This joint action restates our long-held commitment to be at the forefront of research into alternatives to animal testing. For more than 20 years, the industry has been pushing the boundaries of cutting-edge science to develop technologies that would feed into novel, sustainable safety testing strategies in line with the European regulatory framework. Since the ban on animal testing, there is the wish and the scientific capabilities to improve safety assessment approaches based on alternatives.”

At the end of the project the novel risk assessment strategies should find wide application in various regulatory contexts, across industry sectors, and for different population groups, such as patients, workers, consumers, and the public at large. 

The EU-ToxRisk project will kick-off in January 2016 in Leiden, The Netherlands, and will run for a period of six years.

Project Partners

Universities

  • University Leiden, The Netherlands
  • Leiden University Medical Centre, The Netherlands
  • Konstanz University, Germany
  • Katholieke Universiteit Leuven, Belgium
  • Ruprecht-Karls-Universität Heidelberg, Germany
  • Maastricht University, The Netherlands
  • University Of Copenhagen, Denmark
  • Universidad Pompeu Fabra, Spain
  • Fundación para la Investigación del Hospital Universitario La Fe de la Comunidad Valenciana, Spain
  • University of Vienna, Austria
  • Medical University of Innsbruck, Austria

Research Institutions

  • Forschungsgesellschaft für Arbeitsphysiologie und Arbeitsschutz (IFADO), Germany
  • Karolinska Institutet/Swedish Toxicology Sciences Research Center, Sweden
  • EMBL/European Bioinformatics Institute, United Kingdom
  • TNO, The Netherlands
  • Institut National de l’Environnement et des Risques, France
  • Istituto di Ricerche Farmacologiche Mario Negri, Italy
  • Center for Alternatives to Animal Testing at the Johns Hopkins Bloomberg School of Public Health, United States of America and at the University of Konstanz, Germany
  • Fraunhofer Society – Fraunhofer ITEM, Germany

Large industry

  • F. Hoffmann – La Roche, Switzerland
  • BASF, Germany
  • Unilever, Safety and Environmental Assurance Centre, United Kingdom
  • L’Oreal, France
  • Cosmetics Europe, Belgium
  • SimCyp, United Kingdom
  • Steinbeis CAAT-Europe at the University of Konstanz, Germany

SMEs

  • InSphero, Switzerland
  • TissUse, Germany
  • BioTalentum, Hungary
  • Douglas Connect, Switzerland
  • Open PHACTS Foundation, United Kingdom
  • Cyprotex, United Kingdom
  • BioDetectionSystems, The Netherlands
  • ARTTIC, France
  • Lhasa, United Kingdom

Regulatory Bodies

  • The Danish Environmental Protection Agency, Denmark
  • Federal Institute for Occupational Safety and Health, Germany
  • Istituto Superiore di Sanità, Italy
  • Medical Research Council, National Centre for the Replacement, Refinement & Reduction of Animals in Research, United Kingdom

For further information on EU-ToxRisk and the project partners see www.eu-toxrisk.eu.

For more information on the H2020 programme, visit     
http://ec.europa.eu/programmes/horizon2020/

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FRAME Training School in Experimental Design and Statistical Analysis
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Advances in Cell and Tissue Culture 2017
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Thomas Hartung will deliver a keynote address

CAAT Academy
Updates on Hepatotoxicity AOP Landscape and on the ADME Field - Season 2
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9th Euro-Global Summit on Toxicology and Applied Pharmacology
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6th Annual Meeting of the American Society for Cellular and Computational Toxicology (ASCCT)
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10th World Congress on Alternatives and Animal Use in the Life Sciences
August 20-24, 2017
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CAAT Academy
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