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RECONSTRUCTED HUMAN EPIDERMIS FOR SKIN ABSORPTION TESTING: RESULTS OF THE GERMAN PREVALIDATION STUDY.
Schafer-Korting1, M., Bock2, U., Gamer3, A., Haberland1, A., Haltner-Ukaomadu2, E., Kaca2, M., Kamp3, H., Kietzmann4, M., Korting5, H.C., Krachter6, H-U., Lehr7, C.M., Liebsch8, M., Mehling6, A., Netzlaff7, F., Niedorf4, F., Rubbelke5, M.K., Schafer7, U., Schmidt8, E., Schreiber1, S., Schroder9, K-R., Spielmann8, H., Vuia1, A.
1Freie Universität Berlin, Institut für Pharmazie, Berlin, Germany, 2Across Barriers GmbH, Saarbrücken, Germany, 3BASF Aktiengesellschaft, Experimental Toxicology and Ecology, Ludwigshafen, Germany, 4Stiftung Tierärztliche Hochschule Hannover, Institut für Pharmakologie, Hannover, Germany, 5Ludwig-Maximilians-Universität München, Klinik und Poliklinik für Dermatologie und Allergologie, München, Germany, 6Cognis Deutschland GmbH & Co. KG, Düsseldorf, Germany, 7Universität des Saarlandes, Biopharmazie u. Pharmazeutische Technologie, Saarbrücken, Germany, 8ZEBET, Berlin, Germany, 9Henkel KGaA, Düsseldorf, Germany.
ATLA, 34, 283-294 (2006).
Keywords: Cutaneous Uptake, EpiDerm, EpiSkin, Franz diffusion cells (FDC), Lipophilicity, OECD, Percutaneous absorption, Permeation, SkinEthic
Endpoints: Flux, HPLC, Lag Time, Permeation coefficient (Papp)
Materials Tested: Caffeine, Testosterone
Summary:
Exposure to chemicals absorbed by the skin can threaten human health. In order to standardise the predictive testing of percutaneous absorption for regulatory purposes, the OECD adopted guideline 428, which describes methods for assessing absorption by using human and animal skin.
In this study conducted by scientists at the Freie Universität Berlin, Across Barriers GmbH, BASF Aktiengesellschaft Experimental Toxicology and Ecology, the Institut für Pharmakologie, Ludwig-Maximilians-Universität München, Cognis Deutschland GmbH & Co. KG, Universität des Saarlandes, ZEBET (Berlin, Germany), and Henkel KGaA, a protocol based on the OECD principles was developed and prevalidated by using reconstructed human epidermis (RHE) including MatTek’s EpiDerm human skin tissue equivalent. The permeation of the OECD standard compounds, caffeine and testosterone, through commercially available reconstructed human epidermis (RHE) models was compared to that of human epidermis and animal skin.
In comparison to human epidermis, the permeation of the chemicals was overestimated when using reconstructed human epidermis (RHE). The following ranking of the permeation coefficients for testosterone was obtained: SkinEthic > EpiDerm, EPISKIN > human epidermis, bovine udder skin, pig skin. The ranking for caffeine was: SkinEthic, EPISKIN > bovine udder skin, EpiDerm, pig skin, human epidermis.
The inter-laboratory and intra-laboratory reproducibility was good. Long and variable lag times, which are a matter of concern when using human and pig skin, did not occur with reconstructed human epidermis (RHE).
Due to the successful transfer of the protocol, it is now in the validation process.
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Percutaneous Absorption (EpiDerm Application)
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