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An Integrated European ‘Flagship’ Program Driving Mechanism-based Toxicity Testing and Risk Assessment for the 21st Century

Objective

The vision of EU-ToxRisk is to drive a paradigm shift in toxicology towards an animal-free, mechanism-based integrated approach to chemical safety assessment. The project will unite all relevant disciplines and stakeholders to establish: i) pragmatic, solid read-across procedures incorporating mechanistic and toxicokinetic knowledge; and ii) ab initio hazard and risk assessment strategies of chemicals with little background information. The project will focus on repeated dose systemic toxicity (liver, kidney, lung and nervous system) as well as developmental/reproduction toxicity. Different human tiered test systems are integrated to balance speed, cost and biological complexity. EU-ToxRisk extensively integrates the adverse outcome pathway (AOP)-based toxicity testing concept. Therefore, advanced technologies, including high throughput transcriptomics, RNA interference, and high throughput microscopy, will provide quantitative and mechanistic underpinning of AOPs and key events (KE). The project combines in silico tools and in vitro assays by computational modelling approaches to provide quantitative data on the activation of KE of AOP. This information, together with detailed toxicokinetics data, and in vitro-in vivo extrapolation algorithms forms the basis for improved hazard and risk assessment. The EU-ToxRisk work plan is structured along a broad spectrum of case studies, driven by the cosmetics, (agro)-chemical, pharma industry together with regulators. The approach involves iterative training, testing, optimization and validation phases to establish fit-for-purpose integrated approaches to testing and assessment with key EU-ToxRisk methodologies. The test systems will be combined to a flexible service package for exploitation and continued impact across industry sectors and regulatory application. The proof-of-concept for the new mechanism-based testing strategy will make EU-ToxRisk the flagship in Europe for animal-free chemical safety assessment.
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Coordinator

UNIVERSITEIT LEIDEN

Address

Rapenburg 70
2311 Ez Leiden

Netherlands

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 4 672 069,50

Participants (40)

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UNIVERSITAT KONSTANZ

Germany

EU Contribution

€ 1 408 187,50

UNIVERSITEIT MAASTRICHT

Netherlands

EU Contribution

€ 1 282 235

BASF SE

Germany

EU Contribution

€ 695 410

UNILEVER U.K. CENTRAL RESOURCES LIMITED

United Kingdom

EU Contribution

€ 21 000

KAROLINSKA INSTITUTET

Sweden

EU Contribution

€ 1 295 810

INSTITUT NATIONAL DE L ENVIRONNEMENT ET DES RISQUES INERIS

France

EU Contribution

€ 725 015

COSMETICS EUROPE - THE PERSONAL CARE ASSOCIATION

Belgium

BIOTALENTUM TUDASFEJLESZTO KFT

Hungary

EU Contribution

€ 744 476

BioDetection Systems B.V.

Netherlands

EU Contribution

€ 960 218,75

KATHOLIEKE UNIVERSITEIT LEUVEN

Belgium

EU Contribution

€ 790 690

NEDERLANDSE ORGANISATIE VOOR TOEGEPAST NATUURWETENSCHAPPELIJK ONDERZOEK TNO

Netherlands

EU Contribution

€ 626 345

FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V.

Germany

EU Contribution

€ 1 057 335

FORSCHUNGSGESELLSCHAFT FUR ARBEITSPHYSIOLOGIE UND ARBEITSSCHUTZ E.V.

Germany

EU Contribution

€ 930 375

ARTTIC

France

EU Contribution

€ 1 395 580

EDELWEISS CONNECT GMBH

Switzerland

ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI

Italy

EU Contribution

€ 930 065

CERTARA UK LIMITED

United Kingdom

EU Contribution

€ 670 765

MEDIZINISCHE UNIVERSITAT INNSBRUCK

Austria

EU Contribution

€ 256 237

ACADEMISCH ZIEKENHUIS LEIDEN

Netherlands

EU Contribution

€ 773 260

UNIVERSIDAD POMPEU FABRA

Spain

EU Contribution

€ 723 190

EUROPEAN MOLECULAR BIOLOGY LABORATORY

Germany

EU Contribution

€ 850 005

UNIVERSITAT WIEN

Austria

EU Contribution

€ 594 061,05

FUNDACION PARA LA INVESTIGACION DEL HOSPITAL UNIVERSITARIO LA FE DE LA COMUNIDAD VALENCIANA

Spain

EU Contribution

€ 641 940

KOBENHAVNS UNIVERSITET

Denmark

EU Contribution

€ 767 500

F. HOFFMANN-LA ROCHE AG

Switzerland

CYPROTEX DISCOVERY LIMITED

United Kingdom

EU Contribution

€ 1 176 455

TISSUSE GMBH

Germany

EU Contribution

€ 695 065

John Hopkins University

United States

EU Contribution

€ 515 762,50

INSPHERO AG

Switzerland

RUPRECHT-KARLS-UNIVERSITAET HEIDELBERG

Germany

EU Contribution

€ 457 718,75

STEINBEIS GMBH & CO. KG FUER TECHNOLOGIETRANSFER

Germany

EU Contribution

€ 804 130

The Danish Environmental Protection Agency

Denmark

EU Contribution

€ 77 750

L'OREAL SA

France

EU Contribution

€ 14 440

BUNDESANSTALT FUER ARBEITSSCHUTZ UND ARBEITSMEDIZIN

Germany

EU Contribution

€ 53 250

ISTITUTO SUPERIORE DI SANITA

Italy

EU Contribution

€ 64 000

UNITED KINGDOM RESEARCH AND INNOVATION

United Kingdom

EU Contribution

€ 71 570

MEDICAL RESEARCH COUNCIL

United Kingdom

OPEN PHACTS FOUNDATION LBG

United Kingdom

EU Contribution

€ 11 000

LHASA LIMITED

United Kingdom

EU Contribution

€ 325 000

STICHTING VU

Netherlands

EU Contribution

€ 720 387,95

Project information

Grant agreement ID: 681002

Status

Ongoing project

  • Start date

    1 January 2016

  • End date

    31 December 2021

Funded under:

H2020-EU.3.1.6.

  • Overall budget:

    € 30 122 153,25

  • EU contribution

    € 27 798 299

Coordinated by:

UNIVERSITEIT LEIDEN

Netherlands