Alternative tests with better results and less use of animals

There is a patent demand in the pharmaceutical, cosmetic and chemical industry for new alternative testing in order to assess the acute toxicity of new drugs, cosmetic ingredients or industrial chemical products that have to be in contact with humans or the natural environment.

The aim is to reduce the time for and cost of studies for the development of new active elements and reduce the number of experimental animals. Equally, these tests enable direct work on human cell lines instead of on animals, in order to study the toxicity of the liver or kidney, amongst other organs.

To this end, the validation of this new in vitro work methodology, compared to the conventional in vivo one is urgently needed, not only by corporate industry but also by the European Directives themselves. Both REACH (the UE regulating body for chemical products) and the 7th amendment to the Directive on cosmetics propose the replacement in, the short term, of animal experimentation. Currently, while a number of animal testing procedures for toxicity have been successfully substituted by alternative methods, systemic toxicities require new strategic tests to reach a suitable level of safety for the consumer.

In this context, and thanks to its potential in terms of infrastructure as well as qualified and experienced personnel (BPL certificates -10.BPLI/98.01/001 MSC-), in August 2003 GAIKER became part of A-Cute-Tox, a platform financed by the UE and made up of 37 companies and research centres (Integrated Project) drawn from 13 European countries. Its aim is to develop a simple and robust in vitro testing strategy for the prediction of acute human systemic toxicity, which can substitute the tests for acute animal toxicity currently used as regulators.

This approach requires the dimensions of a transnational integrated project, and the involvement of prominent toxicity research groups in the European Union, strict supervision and the introduction of the regulating community and professional handling. It offers the real possibility of getting a substantial reduction of experiments with acute animal systemic toxicity. The involvement of the European Centre for Validation of Alternative Methods (ECVAM) in the management of the project and the other regulatory bodies, such as the ECB (European Chemicals Bureau), guarantees control of the final goal of the project.