Reconstructed epidermis versus human and animal skin in skin absorption studies

European chemical policy in general and the REACH initiative in particular will increase the number of chemical substances submitted to toxicological evaluation by several orders of magnitude compared to the current status. To limit animal exposure the resulting enormous increase in testing, however...

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Bibliographic Details
Published in:Toxicology in vitro 2005-09, Vol.19 (6), p.813-822
Main Authors: Schreiber, S., Mahmoud, A., Vuia, A., Rübbelke, M.K., Schmidt, E., Schaller, M., Kandárová, H., Haberland, A., Schäfer, U.F., Bock, U., Korting, H.C., Liebsch, M., Schäfer-Korting, M.
Format: Article
Language:English
Subjects:
Administration, Topical
Alternative methods
Animals
Caffeine - administration & dosage
Caffeine - pharmacokinetics
Cell Survival
Central Nervous System Stimulants - administration & dosage
Central Nervous System Stimulants - pharmacokinetics
Cryopreservation
Culture Media
Epidermis - metabolism
Epidermis models
Hot Temperature
Humans
In Vitro Techniques
Reconstructed human epidermis
Regulatory toxicology
Replacement of animal experiments
Skin
Skin - metabolism
Skin absorption
Skin Absorption - physiology
Skin models
Swine
Testosterone - administration & dosage
Testosterone - pharmacokinetics
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Summary:European chemical policy in general and the REACH initiative in particular will increase the number of chemical substances submitted to toxicological evaluation by several orders of magnitude compared to the current status. To limit animal exposure the resulting enormous increase in testing, however, asks for validated in vitro test systems. While the OECD favours in vitro testing for cutaneous absorption using viable human and animal skin (Guideline 428) the availability of viable human skin is already limited today. We present a comparison of various in vitro techniques suitable for routine skin absorption studies including commercially available reconstructed human epidermis which may be a reliable alternative to excised human and animal skin. In order to develop a protocol for the subsequent transfer to partner laboratories the experimental set-up was analysed stepwise using the OECD reference compounds caffeine and testosterone. Franz cell type, the donor and receptor media for hydrophilic/lipophilic substances, albumin and tensid addition, and storage conditions of the excised skins were systematically varied. A protocol has been developed which now allows to proceed to the pre-validation process.
ISSN:0887-2333
1879-3177
DOI:10.1016/j.tiv.2005.04.004