Objective The testing of cosmetological (and pharmaceutical) preparations will have to be performed in a near future by procedures alternative to animal experiments to comply with the Sixth Amendment (93-35-EEC) to the EC Cosmetic Directive (976- 768-EEC). In vitro recombined skin using human cells represents an elegant procedure for this purpose. The presently available models suffer imperfections that will be addressed in the present project to aim at the preparation of an in-vitro test for skin irritancy. It will display meaningful endpoints, should prove reproducible by the use of chemically defined culture products and immortalised cell lines and be easy-to-use by introducing adequate markers of the irritant reaction. The programme will be a shared activity of six academic research units representing a large part of the scientific european potential in the domain and associated industrial laboratories experts in the use of reconstructed skin for irritant testing. The project will be developed in four partially overlapping steps addressing to defined problems. Step 1- improvement of the quality of the stratum corneum in-vitro, introduction of endothelial cells in the dermal compartment and determination of in-vivo related endpoints of irritancy. Step 2 - replacement of the human cell strains by immortalised human cell lines and determination of the conditions required to obtain near physiological functions and the above determined selected end-points of the irritant reaction. Step 3 introduction of the markers of the irritant reaction by infection or transfection of constructions made of a reporter gene driven by the promoter of a protein participating in the process in the different lines of cells (keratinocytes, fibroblasts and endothelial cells). Step 4 - preparation of a model suitable for prevalidation testing in collaboration with industrial partners. The benefits of the project is scientific by the european collaboration required to address to the specific know-how of the different types of cells included in the model, economical by helping the industry to comply to the EEC directives and ethical by a contribution to the faster suppression of testing in animals by an alternative procedure. Fields of science natural sciencesbiological sciencesbiochemistrybiomoleculesproteins Programme(s) FP4-BIOTECH 2 - Specific research, technological development and demonstration programme in the field of biotechnology, 1994-1998 Topic(s) 070104 - Cell cultures for the development of in vitro tests Call for proposal Data not available Funding Scheme CSC - Cost-sharing contracts Coordinator Université de Liège Address 4000 Liège Belgium See on map EU contribution € 0,00 Participants (5) Sort alphabetically Sort by EU Contribution Expand all Collapse all Institut National de la Santé et de la Recherche Médicale France EU contribution € 0,00 Address Avenue claude vellefaux 75475 Paris See on map Istituto di Ricerche Farmacologiche Mario Negri Italy EU contribution € 0,00 Address Via eritrea 62 20157 Milano See on map Rijksuniversiteit Leiden Netherlands EU contribution € 0,00 Address 10,rijnsburgerweg 2300 RC Leiden See on map Stiftung Deutsches Krebsforschungszentrum Germany EU contribution € 0,00 Address 280,im neuenheimer feld 69120 Heidelberg See on map Universität Köln Germany EU contribution € 0,00 Address 9,joseph stelzmann straße 50931 Köln See on map