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Optimisation and pre-validation of an in vitro test strategy for predicting human acute toxicity

Optimisation and pre-validation of an in vitro test strategy for predicting human acute toxicity

Objective

Validated alternative test methods are urgently required for safety toxicology of drugs, chemicals and cosmetics. Both REACH and 7th amendment of Cosmetics Directive call for the broad replacement of animal experiments on a short-term. While some animal tests for topical toxicity have been successfully replaced one by one by alternative methods, systemic toxicities require new test strategies in order to achive an adequate safety level. The aim of A-Cute-Tox is to develop a simple and robust in vitro t esting strategy for prediction of human acute systemic toxicity, which could replace the animal acute toxicity tests used today. The involvement of ECVAM in the project management and that of regulators (such as ECB) guarantees of the follow-up. The Scie ntific objectives of the project are: 1. Compilation, critical evaluation and generation of high quality in vitro and in vivo data for comparative analysis. 2. Identifying factors (ADE, metabolism and organ specificity) that influence the correlation betwe en in vitro toxicity (concentration) and in vivo toxicity (dosage), and to define an algorithm that accounts for this. 3. Explore innovative tools and cellular systems to identify new end-points and strategies to better anticipate animal and human toxicit y. 4. To design a simple, robost and reliable in vitro test strategy amenable for robotic testing, associated with the prediction model for acute toxicity. The project will develop the concepts required to compose testing strategies via the continuous imp lementation of novel in vitro and in silico alternatives. The approach requires the dimensions of a transnational Integrated Project, involving prominent toxicity research groups in the EU, close monitoring by and input from the regulatory community and p rofessional managerial steering. In return, it offers the realistic opportunity to achive a substantial reduction of animal experiments in acute systemic toxicity assessments.

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Coordinator

UNIVERSITY OF OULU

Address

Pentti Kaiteran Katu 1
8000 Oulu

Finland

Administrative Contact

Leila RISTELI (Dr)

Participants (35)

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EXPERTRÅDET ECB MILJÖKOMPETENS AB

Sweden

FUNDACIÓN HOSPITAL UNIVERSITARIO LA FE

Spain

JOINT RESEARCH CENTRE (EUROPEAN COMMISSION DG JRC)

Belgium

NEUROPHARMA S.A.

Spain

UTRECHT UNIVERSITY

Netherlands

BIOVITRUM AB

Sweden

THE UNIVERSITY OF NOTTINGHAM

United Kingdom

UNIVERSITAT DE VALENCIA. ESTUDI GENERAL (THE UNIVERSITY OF VALENCIA)

Spain

COMMISSARIAT À L'ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES

France

CENTRO DE INVESTIGACIONES ENERGETICAS, MEDIOAMBIENTALES Y TECNOLOGICAS

Spain

UNIVERSITÉ CATHOLIQUE DE LOUVAIN

Belgium

CONSEJO SUPERIOR DE INVESTIGACIONES CIENTIFICAS

Spain

SCIENTIFIC INSTITUTE OF PUBLIC HEALTH

Belgium

ADVANCELL ADVANCED IN VITRO CELL TECHNOLOGIES, S.A.

Spain

STOCKHOLMS UNIVERSITET

Sweden

BAYER HEALTH CARE

Germany

THE UNIVERSITY COURT OF THE UNIVERSITY OF ABERDEEN

United Kingdom

MEDICAL UNIVERSITY OF WARSAW

Poland

UNIVERSITÉ DE LAUSANNE

Switzerland

VRIJE UNIVERSITEIT BRUSSEL

Belgium

FUNDACIÓN GAIKER

Spain

KUNGLIGA TEKNISKA HÖGSKOLAN

Sweden

NATIONAL UNIVERSITY OF IRELAND, DUBLIN

Ireland

UMEÅ UNIVERSITY

Sweden

ISTITUTO SUPERIORE DI SANITA '

Italy

UNIVERSITÄT ZÜRICH

Switzerland

FRAUNHOFER GESELLSCHAFT ZUR FÖRDERUNG DER ANGEWANDTEN FORSCHUNG E.V

Germany

PALACKY UNIVERSITY, OLOMOUC

Czechia

IN VITRO TESTING INDUSTRIAL PLATFORM

Netherlands

UNIVERSITY OF KONSTANZ, CENTRE FOR HEALTH AND CONSUMER PROTECTION

Germany

UPPSALA UNIVERSITY

Sweden

UNIVERSITE D'ARTOIS

France

SWEDISH FUND FOR RESEARCH WITHOUT ANIMAL EXPERIMENTS

Sweden

UNIVERSITAT DE BARCELONA

Spain

FUTURE PARTICIPANT 1

Afghanistan

Project information

Grant agreement ID: 512051

  • Start date

    1 January 2005

  • End date

    30 June 2010

Funded under:

FP6-LIFESCIHEALTH

  • Overall budget:

    € 12 112 179

  • EU contribution

    € 7 664 665

Coordinated by:

UNIVERSITY OF OULU

Finland