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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)

Das Projekt "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)" wird vom Umweltbundesamt gefördert und von Universitätsklinikum Tübingen Institut für Experimentelle und Klinische Pharmakologie und Toxikologie, Abteilung Toxikologie durchgeführt. Validated alternative test methods are urgently required for safety toxicology of drugs, chemicals and cosmetics. 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 achieve an adequate safety level of the consumer. In the project, ECVAM takes the lead to manage the development of a conceptual framework in the area of reproductive toxicity. The involvement of all stakeholders in the Project Board including the European Consensus Platform on Alternatives (ECOPA), European regulators, OECD, and Industry guarantees an efficient problem solving approach. Reproductive toxicity offers the opportunities that: i) a substantial number of animals are currently required in in-vivo assays; ii) the reproductive system can be broken down into well-defined sub-elements covering the reproductive cycle; iii) a number of pioneering alternatives have already been developed; and iv) the same animal experiments are carried out for drugs, chemicals and cosmetics. The project is composed of four elements, i.e. a) technological development of in vitro and b) sensor technologies c) the strategical development of a conceptual framework d) the dissemination and implementation activities. The project will develop the concepts required to compose testing strategies via the continuous implementation of novel in vitro and in silico alternatives. Problems to be solved include the development of substantial numbers of alternative test methods making use of advanced technologies. This approach requires the dimensions of a transnational Integrated Project, involving some of the most prominent reproductive toxicity research groups in the EU, close monitoring by and input from the regulatory community and professional managerial steering. In return, it offers the realistic opportunity to achieve a substantial reduction of animal experiment.

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