An Integrated European ‘Flagship’ Programme Driving Mechanism-based Toxicity Testing and Risk Assessment for the 21st century.
For more information, visit the EU-ToxRisk website.
EU-ToxRisk aims to deliver human-relevant testing strategies to identify and enable reliable, animal-free hazard and risk assessment of chemicals.
The vision is to drive the required paradigm shift in toxicological testing away from animal use and towards a toxicological assessment based on human cell responses and a comprehensive mechanistic understanding of cause-consequence relationships for chemical adverse effects.
EU-ToxRisk is a collaborative project funded by the EU Framework Programme for Research and Innovation, Horizon 2020. With 39 partner organisations and a budget of over €30 million, the project started on 1st January 2016 and will run for 6 years. The multidisciplinary project partners include Universities, Research Institutes, large industry companies, SMEs and regulatory bodies. For a full list, please visit the EU-ToxRisk website.
In order to push the entire field forward towards a universal chemical safety testing strategy, mechanism-based test methods will be designed. These test methods will be both in line with regulatory frameworks, and suitable for industrial implementation.
The focus of the project is on two areas:
- Repeated dose systemic toxicity (lung, kidney, liver and nervous system)
- Developmental and reproductive toxicity (DART)
EU-ToxRisk will work towards developing models that can be used for risk assessments. The project has defined case studies which are separated into categories depending on:
- Whether the compound is part of a group of compounds with similar Mode of Action (MoA) or a shared Key Event (KE)
- Whether the compound is part of a group of compounds with similar structures.
The models will be tested on the case studies to determine whether they are fit for purpose and to develop Integrated Approaches to Testing and Assessment (IATAs).
- Universal Safety Testing Strategy: Industry-standard testing strategies will allow the entire field to be pushed forward in an integrated manner.
- Improved Prediction for the Human Situation: One of the main aims of EU-ToxRisk is to deliver human-relevant testing strategies.
- Time and Cost Savings: The use of these models may result in time and cost savings if they replace long-lasting, expensive animal studies.
- Comprehensive Mechanistic Understanding: EU-ToxRisk research will result in a more thorough understanding of chemical adverse effects in humans.
Lhasa Limited is involved in four main areas of the project:
- Knowledge and Data Infrastructure
- Providing advice regarding infrastructure requirements and sustainability
- Collecting and peer reviewing metabolite data
- QSAR, cheminformatics and bioinformatics approaches
- Conducting literature reviews of existing metabolite models and resources
- Providing metabolism predictions and expertise for case studies
- Participating in the Similarity taskforce
- Developing novel methods for similarity and grouping
- In vitro/in silico biokinetics, ADME and Physiologically Based Pharmacokinetic (PBPK) modelling
- Contributing to the outlining of requirements and relevant PK data harvesting
- Exploitation, commercialization and implementation
- Participating in the Innovation task force
- Contributing experience of the sustainability of previous EU-funded projects (eTOXsys)