Skip to main content
European Commission logo
English English
CORDIS - EU research results
CORDIS
CORDIS Web 30th anniversary CORDIS Web 30th anniversary

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

Project description

Chemical safety assessment with animal-free approaches

Current toxicology practices rely heavily on animal testing, a process facing ethical concerns and limited predictive value for human health. In this context, the EU-funded EU-ToxRisk project will drive a paradigm shift towards an animal-free, mechanism-based integrated approach to chemical safety assessment. With a primary focus on repeated dose systemic toxicity and developmental/reproductive toxicity, EU-ToxRisk integrates a range of human tiered test systems that strike a balance between efficiency, cost-effectiveness and biological complexity. The project harnesses cutting-edge technologies, including high-throughput transcriptomics, RNA interference and high-throughput microscopy, to provide quantitative and mechanistic insights into the adverse outcome pathways and key events that underpin toxicity. The project will establish fit-for-purpose integrated approaches to testing and assessment.

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.

Call for proposal

H2020-PHC-2014-2015

See other projects for this call

Sub call

H2020-PHC-2015-single-stage_RTD

Coordinator

UNIVERSITEIT LEIDEN
Net EU contribution
€ 5 032 069,50
Address
RAPENBURG 70
2311 EZ Leiden
Netherlands

See on map

Region
West-Nederland Zuid-Holland Agglomeratie Leiden en Bollenstreek
Activity type
Higher or Secondary Education Establishments
Links
Total cost
€ 5 032 069,50

Participants (43)