Animal-friendly hazard assessment of chemicals given strong impetus

21 Oct 2015

Animal experiments are still commonly used to prepare toxicological profiles of chemicals. The European project EU-ToxRisk has 39 organizations working together to find animal-free alternatives, with academia, industry and the authorities joining forces to meet this major technical challenge.

The European REACH Directive requires chemical manufacturers and importers to have produced hazard assessments for all chemicals on the European market by 2018. Data on each chemical must be published stating the risk when humans and the environment come into contact with it and the concentrations at which this is safe or hazardous. This involves the toxicological profiles of a total of over 30,000 chemicals. Animal experiments are still in widespread use to investigate the toxic effects of chronic exposure and on embryo development and reproduction. The European Union is very keen to find alternatives, and this has now been given an added boost by the setting-up of the EU-ToxRisk project.

No more live animals

The aim of EU-ToxRisk is to replace research on intact live animals (in vivo) with research on animal or human cells (in vitro) and to take advantage of the large amount of information and knowledge already available and its predictive power (in silico). TNO’s Dinant Kroese explains: ‘Finding animal-free alternatives places heavy demands on our expertise. Testing on cells is relatively simple, but we still have to translate what we observe there to the situation in humans exposed via the mouth, lungs or skin.’ 

Existing experience

TNO already has experience of this approach in the DIAMONDS programme (Data warehouse Infrastructure for Algorithms, Models & Ontologies towards Novel Design and Safety). This uses existing data and in vitro models to predict the in vivo effects. ‘Thanks to this experience and the expertise we already have of classic risk assessment of chemicals we have been able to contribute to the design of EU-ToxRisk. The question we asked ourselves was this: if we want to apply this methodology in REACH, what knowledge and expertise do we need and how can we organize it?’

Animal studies not always more reliable

In addition to the enormous technical challenge of finding alternatives to in vivo studies, communication is very important. Some regulators have the perception that animal studies are by definition more reliable than any possible alternative. ‘But every methodology has its uncertainties’, says Kroese. ‘We need to identify those uncertainties so that they can be compared. Then the regulator will understand that the new methodology is better than the old one.’

Two large working groups

EU-ToxRisk starts work officially in January 2016 and will receive funding of 30 million euros over six years. Managing projects of this magnitude will always be a challenge. ‘That’s why we’re not working in lots of small groups but pooling disciplines in two large working groups, one on chronic exposure and one on embryo development and reproduction.’ Kroese, who leads the second working group, is optimistic about the project: ‘I feel we have drive and focus and I’m very hopeful that EU-ToxRisk will produce useful results.’

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