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Imprint
Characterization of metabolizing enzymes and biotransformation of selected test substances in human in-vitro skin models to identify an optimal test system for dermato-toxicological and exposure-related studies
Project
Project code: BfR-PRS-08-1334-190
Contract period: 01.02.2009
- 31.01.2011
Purpose of research: Applied research
The aim of the project is to provide a reliable scientific basis for in-vitro testing of skin sensitization and dermal genotoxicity. The metabolic capacity of several in-vitro skin models (reconstructed human epidermis and full-thickness skin models, cultured keratinocytes/skin cells, subcellular fractions of skin cells) will be investigated and compared with human ex-vivo skin, in respect to biotransformation of test substances and patterns of metabolizing enzymes. Using this approach, the best suitable model/models for pharmacological and toxicological studies of dermally metabolized substances will be identified. These models can be further used to design and optimize applications or test-methods for specific toxicological end points, as for example cytotoxicity and genotoxicity. Depending on progress, this work will be continued to pre-validate test methods for dermal toxicity, in order to replace animal experiments. This issue is of high importance in Europe, because strict time-limits for animal testing of cosmetic ingredients had been introduced by the 7th amendment of the Cosmetics Directive 76/768/EWG.In this project, the metabolization of a number of test substances will be analyzed in human 3D-skin models, cultured human cells and ex-vivo skin, as well as activities and expression patterns of metabolizing enzymes. This investigation will also address applicability of test systems and methods for defined toxicological end points. It is aimed to establish standard protocols for all methods and to initiate a validation of these procedures as a consecutive project.
Section overview
Subjects
- Animal health
