The use of reconstructed human epidermis for skin absorption testing: Results of the validation study
| Autor: | Hans-Udo Krächter, Walter Diembeck, Silke Kersen, Hans-Jürgen Düsing, Alexander Vuia, Christine Hoffmann, Annette Mehling, Monika Schäfer-Korting, Manfred Kietzmann, Claus-Michael Lehr, Eleonore Haltner-Ukomadu, Udo Bock, Hans Christian Korting, Monika Kaca, Horst Spielmann, Elisabeth Schmidt, Hennicke Kamp, A.O. Gamer, Frank Niedorf, Frank Netzlaff, Manfred Liebsch, Michaela Weimer, S. Schreiber, M.K. Rübbelke, Christel C. Müller-Goymann, Ulrich Schäfer |
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| Předmět: |
medicine.medical_specialty
Validation study Swine Skin Absorption Formal validation Human skin Absorption (skin) Biology Toxicology Animal Testing Alternatives General Biochemistry Genetics and Molecular Biology Pig skin Organ Culture Techniques Statistical analyses Caffeine medicine Animals Humans Mannitol Ivermectin integumentary system Reproducibility of Results General Medicine Permeation Plastic Surgery Procedures Skin Irritancy Tests Dermatology Total variability Flufenamic Acid Medical Laboratory Technology Epidermis Biomedical engineering |
| Zdroj: | Scopus-Elsevier |
| Popis: | A formal validation study was performed, in order to investigate whether the commercially-available 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 finite-dose 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. |
| Databáze: | OpenAIRE |
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