title: Reconstructed human epidermis for skin absorption testing: results of the German prevalidation study.
abstract: 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, a protocol based on the OECD principles was developed and prevalidated by using reconstructed human epidermis (RHE). The permeation of the OECD standard compounds, caffeine and testosterone, through commercially available 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 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 RHE. Due to the successful transfer of the protocol, it is now in the validation process.
authors.affiliation: Freie Universität Berlin, Institut für Pharmazie, Königin-Luise-Strasse 2-4, 14195 Berlin, Germany. msk@zedat.fu-berlin.de
authors.forename: Monika
authors.initials: M
authors.lastname: Schäfer-Korting
authors.forename: Udo
authors.initials: U
authors.lastname: Bock
authors.forename: Armin
authors.initials: A
authors.lastname: Gamer
authors.forename: Annekathrin
authors.initials: A
authors.lastname: Haberland
authors.forename: Eleonore
authors.initials: E
authors.lastname: Haltner-Ukomadu
authors.forename: Monika
authors.initials: M
authors.lastname: Kaca
authors.forename: Hennicke
authors.initials: H
authors.lastname: Kamp
authors.forename: Manfred
authors.initials: M
authors.lastname: Kietzmann
authors.forename: Hans Christian
authors.initials: HC
authors.lastname: Korting
authors.forename: Hans-Udo
authors.initials: HU
authors.lastname: Krächter
authors.forename: Claus-Michael
authors.initials: CM
authors.lastname: Lehr
authors.forename: Manfred
authors.initials: M
authors.lastname: Liebsch
authors.forename: Annette
authors.initials: A
authors.lastname: Mehling
authors.forename: Frank
authors.initials: F
authors.lastname: Netzlaff
authors.forename: Frank
authors.initials: F
authors.lastname: Niedorf
authors.forename: Maria K
authors.initials: MK
authors.lastname: Rübbelke
authors.forename: Ulrich
authors.initials: U
authors.lastname: Schäfer
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Schmidt
authors.forename: Sylvia
authors.initials: S
authors.lastname: Schreiber
authors.forename: Klaus-Rudolf
authors.initials: KR
authors.lastname: Schröder
authors.forename: Horst
authors.initials: H
authors.lastname: Spielmann
authors.forename: Alexander
authors.initials: A
authors.lastname: Vuia
mesh_terms: D000328:Adult; D000368:Aged; D000826:Animal Testing Alternatives / Q000379:methods*; D000818:Animals; D002110:Caffeine / Q000493:pharmacokinetics; D002417:Cattle; D004817:Epidermis / Q000378:metabolism*; D005260:Female; D005858:Germany; D006801:Humans; D008875:Middle Aged; D009924:Organ Culture Techniques; D015203:Reproducibility of Results; D012869:Skin Absorption / Q000502:physiology*; D013552:Swine; D013739:Testosterone / Q000493:pharmacokinetics
chemical_list: D002110:Caffeine; D013739:Testosterone