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Validation study for testing of skin penetration using biotechnologically devised human skin equivalents. Phase 2: Validation
Project
Project code: BfR-QUER-02-1334-172
Contract period: 01.12.2004
- 28.02.2006
Purpose of research: Applied research
The aim of this project is to reduce the number of animal experiments for the investigation of cutaneous penetration and permeation of compounds by a standardised in vitro approach. The final goal is a validated alternative approach based on biotechnologically obtained and commercially available human skin models to be used for the development and testing of new, or not yet finally characterised chemical entities, such as pesticides and pharmaceuticals. This approach should be capable of critically reducing or abolishing the currently high numbers of so far indispensable animal experiments. It should become feasible by extending the recently published OECD test guideline 428 according to a suggestion of the corresponding Guidance Document No. 28 for the in vitro quantification of the skin penetration and permeation by compounds to the reconstructed human skin models. Due to the adoption of these documents the in-vitro/in vivo comparison is dispensable. The study design is based on the fundamental results of Phase 1 (development of the method, protocol transfer) as well as general corresponding recommendations by the OECD. It thus includes testing of several test substances, which widely vary in lipophilicity and molecular weight. Tissue-related variations become obvious from the results of infinite-dose-experiments. Finally, finite-dose-experiments including a mass balance will be performed using two selected compounds and one human skin model.
Section overview
Subjects
- Biotechnology
