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Background and rationaleHET-CAM

Chemical compounds and preparations have to be assessed for possible human health hazard (Council Directive 67/548/EEC and 88/389/EEC). In vivo tests have been developed and refined with the aim to detect and characterise inherent toxic properties and their dose-effect relationships. The tests have been standardised at an international level within the OECD test Guideline Programme. The acceptance is mandatory for OECD member countries. The tests cover the most important health endpoints for safe handling of chemicals and products and reflect the current state-of-art in hazard identification testing.

According to the Council Directive 86/609/EEC on the protection of animals for experimental and other scientific purposes, OECD guidelines include that an experiment entailing the use of animals shall not be performed if another scientifically satisfactory method is reasonably and practically available to obtain the results sought. In the context of laboratory animal use, “alternatives” include all procedures that completely replace the need for animal experiments, reduce the number of animals required, or diminish the amount of distress or pain suffered by animals in meeting the essential needs of man and other animals (Smyth, 1978). This definition embodies the 3Rs concept proposed by Russel & Burch (1959) and the laws of many countries andBild Directive 86/609/EEC of the European Union now require that replacement alternatives, reduction alternatives and refinement alternatives should be used whenever possible.

Taking into account this rationale and the increase scientific knowledge in the mechanisms underlying toxic effects, scientist of official control laboratories (ECVAM, ZEBET) evaluated possible in vitro tests for the identification of hazard compounds. A number of scientifically validated test methods are available today which have been integrated into the regulatory test guidelines. However, there is a lack of specific training and continuous exercise to overcome the reluctance to change and expedite the implementation of new test methods.

The Invitrotrain project is initialized in order to overcome this hurdle: Regulatory accepted and/or scientifically validated test methods will be imparted during the training courses. The training courses will cover the use of validated methods in the area of acute skin and eye toxicity, absorption models, reproductive toxicity and ecotoxicology of chemicals.

The theoretical background of each test method will be introduced during seminars and the participants will be instructed to the test performance in laboratory exercise at the bench. General aspects concerning the 3Rs concept will be addressed in the lectures.

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Stand: 08.06.2009