Validation study for testing of skin penetration using biotechnologically devised human skin equivalents. Phase 2: Validation
Description:
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.
Executive Institute:
BfR – Department 3: Scientific Services (BfR - QUER) Details of BfR – Department 3: Scientific Services
Parent institution:
Federal Institute for Risk Assessment (BfR) Details of (BfR) (Berlin)
Contract period:
01. 12. 2004 - 28. 02. 2006
Participating Institutions:
- Free University of Berlin Details of Free University of Berlin
- Ludwig-Maximilians-University of Munich (LMU) Details of LMU
- University of Veterinary Medicine Hannover (TiHo) Details of TiHo
- University of the Saar State Details of University of the Saar State
- BASF SE Details of BASF SE
- Cognis GmbH Details of Cognis GmbH
- Beiersdorf AG Details of Beiersdorf AG
- Across Barriers GmbH Details of Across Barriers GmbH
Funding Programme:
- BMBF - alternative methods to animal testing Details of BMBF - alternative methods to animal testing
Subject:
- Biotechnology
Purpose of research:
Applied research
Funding Institutions:
- Federal Ministry of Education and Research (BMBF) Details of (BMBF)
Project Management Agency:
- Federal Ministry of Education and Research (BMBF) Details of BMBF