Home banner
A-Z Index

Quick way to the find the information that you need...

More button
Register with FRAME

Although you do not need to register, any information you provide will be confidential and used only by FRAME to improve the website

Register button
Account Login
Forgot password?

The Journal


Alternatives to Laboratory Animals - ATLA

Download latest issue button Download back issues button Subscribe to ATLA
Contact Us

Tel icon

Tel: +44 (0)115 9584740

Tel icon

Fax: +44 (0)115 9503570

Make an Enquiry

The Use of Reconstructed Human Epidermis for Skin Absorption Testing: Results of the Validation Study

Monika Schäfer-Korting, Udo Bock, Walter Diembeck, Hans-Jürgen Düsing, Armin Gamer, Eleonore Haltner-Ukomadu, Christine Hoffmann, Monika Kaca, Hennicke Kamp, Silke Kersen, Manfred Kietzmann, Hans Christian Korting, Hans-Udo Krächter, Claus-Michael Lehr, Manfred Liebsch, Annette Mehling, Christel Müller-Goymann, Frank Netzlaff, Frank Niedorf, Maria K. Rübbelke, Ulrich Schäfer, Elisabeth Schmidt, Sylvia Schreiber, Horst Spielmann, Alexander Vuia and Michaela Weimer

A formal validation study was performed, in order to investigate whether the commerciallyavailable reconstructed human epidermis (RHE) models, EPISKIN®, EpiDerm™ and SkinEthic®, are suitable for in vitro skin absorption testing. The skin types currently recommended in the OECD Test Guideline 428, namely, ex vivo human epidermis and pig skin, were used as references. Based on the promising outcome of the prevalidation study, the panel of test substances was enlarged to nine substances, covering a wider spectrum of physicochemical properties. The substances were tested under both infinite-dose and finitedose conditions, in ten laboratories, under strictly controlled conditions. The data were subjected to independent statistical analyses. Intra-laboratory and inter-laboratory variability contributed almost equally to the total variability, which was in the same range as that in preceding studies. In general, permeation of the RHE models exceeded that of human epidermis and pig skin (the SkinEthic RHE was found to be the most permeable), yet the ranking of substance permeation through the three tested RHE models and the pig skin reflected the permeation through human epidermis. In addition, both infinite-dose and finite-dose experiments are feasible with RHE models. The RHE models did not show the expected significantly better reproducibility, as compared to excised skin, despite a tendency toward lower variability of the data. Importantly, however, the permeation data showed a sufficient correlation between all the preparations examined. Thus, the RHE models, EPISKIN, EpiDerm and SkinEthic, are appropriate alternatives to human and pig skin, for the in vitro assessment of the permeation and penetration of substances when applied as aqueous solutions.

Full text pdf 36(2), 161–187