Brussels, 23 June 2004

In the presence of H.R.H. Prince Laurent of Belgium, President of the Prince Laurent Foundation for Animal Welfare, European Research Commissioner Philippe Busquin will today present in Brussels ongoing European research to replace, reduce and refine animal tests.

The research is funded through the European Union¡¯s Sixth Research Framework Programme (FP6, 2002-2006). In particular, two new EU research projects, ReProTect and A-Cute-Tox, will be on display. Advances in bio-medical research for new treatments and drugs, the European Union¡¯s new chemicals policy and the testing requirements of the amended cosmetics directive will be discussed at the briefing.

"The newly developed alternative test methods supported by the EU will substantially contribute to the three Rs of reduction, refinement and replacement of animal experimentation and testing, also guaranteeing the highest safety standards for consumers and patients, respect for the environment and animal welfare," says Commissioner Busquin. "Fostering the Three Rs can only be achieved if there is a joint effort between scientists, national administrations, industry, NGOs and European policy-makers."

The on-site media briefing at the Scientific Institute of Public Health (IPH, Rue Wytsmanstraat 14, B-1050 Brussels, 14:30-18:00), project partner in EU funded research projects, will give journalists the opportunity to visit laboratories and learn about two new EU research projects to develop alternative testing methods.

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What are the "three Rs"?

• "Reduction" aims to obtain reliable information by using fewer animals, or more information from the same number of animals.
• "Refinement" alternatives focus on methods that alleviate or minimise pain, suffering and distress.
• "Replacement" alternatives aim to gather equivalent scientific results without conducting experiments on animals.

Advantages of modern alternative testing methods developed within the new research projects presented today are that 1) the same experiments can be used for drugs, chemicals and cosmetics without using animals and 2) the tests compare toxicity directly between cell or tissue experiments ("in vitro") and the effects on humans ("in vivo"), thus not requiring any animal experiments.

Further information:
For the thematic priority on life sciences, genomics and biotechnology for health in the EU Sixth Research Framework Programme (FP6) see also:
The web site of the Scientific Institute of Public Health can be found at:
In Vitro Testing Industrial Platform

Prince Laurent Foundation for the welfare of domestic and wild animals:
European Centre for the Validation of Alternative Methods , Joint Research Centre, European Commission, Ispra (Italy)

Selected European alternative testing research projects:

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Development of a novel approach in hazard and risk assessment or reproductive toxicity by a combination and application of in vitro, tissue and sensor technologies (ReProTect)

Budget: €13.9 million, EU contribution: €9.1 million, Duration: 5 years

Coordinator: University of Tuebingen, Germany (Contact: Dr. M. Schwarz, michael.schwarz@uni- tuebingen.de )

The Integrated Project ReProTect will develop testing strategies through novel in vitro and in silico (sensor) alternatives to animal testing. It will strive to develop a substantial number of alternative test methods making use of advanced technologies.

Studies in reproductive toxicity within ReProTect will enable scientists to substantially reduce the number of animals that are currently required in "in vivo" tests; use a number of pioneering alternatives that have already been developed; and carry out the same experiments for drugs, chemicals and cosmetics without using animals.

The European Centre for the Validation of Alternative Methods (ECVAM) is leading the project to validate a conceptual framework in the area of reproductive toxicity. Key stakeholders, including the European Consensus Platform on Alternatives (ECOPA), European regulators, OECD, and industry, are involved in the project.

Countries involved: Austria, Belgium, Bulgaria, Denmark, France, Germany, Italy, the Netherlands, Sweden, Switzerland, and the United Kingdom.

Optimisation and pre-validation of an in vitro test strategy for predicting human acute toxicity (A-Cute-Tox)

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Budget: €15.65 million, EU contribution: approx. €9 million

Coordinator: University of Oulu, Finland (Contact: Dr. Leila Risteli, leila.risteli@oulu.fi )

Validated alternative test methods are urgently required for safe toxicology of drugs, chemicals and cosmetics. The EU's new chemicals policy (REACH) and the 7th amendment of the cosmetics directive call for the broad replacement of animal experiments for a short-term period. The aim of the EU Integrated Project, A-Cute-Tox, is to develop a simple and robust in vitro testing strategy to predict human acute systemic toxicity, which could replace the animal acute toxicity tests currently used for regulatory purposes. The scientific objectives of the project are to:

• Compile, critically evaluate and generate high quality in vitro and in vivo data for comparative analysis.
• Identify factors that influence the correlation between in vitro toxicity (concentration) and in vivo toxicity (dosage), and define an algorithm that accounts for this.
• Explore innovative tools and cellular systems to identify new end-points and strategies to better anticipate animal and human toxicity.
• Design a simple, robust and reliable in vitro test strategy to be used for robotic testing, associated with the prediction model for acute toxicity.

Countries involved: Belgium, the Czech Republic, Denmark, Finland, France, Germany, Italy, the Netherlands, Poland, Spain, Sweden, Switzerland, and the United Kingdom.

Glossary

acute toxicity - an adverse effect occurring within 24 hours after a single or multiple dose of a substance is given.

alternatives - testing methods which refine existing ones by minimizing animal distress, reducing the number of animals needed for an experiment, or replacing whole-animal tests with in vitro or other tests.

assay - a qualitative or quantitative test, an experiment

chronic toxicity - effects of repeated or long-term exposure to a substance.

cell culture - growth of living cells in an artificial, controlled environment.

cytotoxicity - the ability of a chemical to damage or kill cells.

genomics - the investigation of the way the genetic make-up, or the genome, translates into biological functions.

in silico - computer-based simulations or mathematical models relating to animal biochemistry, behaviour and environment.

in vitro testing - studies done with cells or tissues cultured in Petri dishes or test tubes. "In vitro" means "in glass" in Latin.

in vivo testing - studies done in the living animal. "In vivo" means "in that which is alive" in Latin.

QSARs - Quantitative Structure/Activity Relationships

REACH - Registration, Evaluation and Authorisation of new and existing Chemicals (draft EU directive).

reproductive toxicity - refers to the adverse effects of a substance on any aspect of the reproductive cycle, including the impairment of the reproductive function, the induction of adverse effects in the embryo, such as growth retardation, malformations, and death.

risk assessment - the process of calculating the toxic effects of exposure to a chemical substance and determining the potential uses of the substance.

test battery - a group of tests.

toxicity testing - In vivo or in vitro experiments designed to reveal a chemical's toxic potential in order to determine the potential uses (or danger of use) for the substance.

toxicology - science which studies how chemicals interact with and affect people, animals, and the environment.

toxicology endpoint - a quantifiable biological change or effect caused by a toxic process.

Item source: Date: 23/06/2004 =>=>=>

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