title: Preliminary performance data of the RHE/IL-18 assay performed on SkinEthic™RHE for the identification of contact sensitizers.
abstract: OBJECTIVE
  The purpose of this study was to evaluate the performances of the RHE/IL-18 assay using the SkinEthic™RHE model for the identification of contact sensitizers.
  
  
  METHODS
  A set of 18 substances and mixtures was tested on this epidermal model, following the RHE/IL-18 protocol. The final results of the assay were obtained following 5 interpretation schemes, to determine the optimal prediction model for this assay with this specific test system. The data were analysed with a special focus on the basal level of IL-18 release and on the performance obtained with respect to three different gold standards: LLNA, HRIPT and an integrated reference, constructed from all available results.
  
  
  RESULTS
  No important differences were found in the performance levels depending on the three gold standards. The performances obtained with the SkinEthic™RHE model support that this model may be considered as an alternative to different reconstructed epidermis models (EpiDERM™, EpiCS™and VUMC-EE) for the performance of RHE/IL-18 assays.
  
  
  CONCLUSIONS
  The prediction model to be used was refined, and more substances have to be tested in order to gather enough data for this evaluation and to determine the right criteria applicable for this assay using the SkinEthic™RHE test system.
authors.affiliation: Oroxcell, 102 Avenue Gaston Roussel, Romainville, 93230, France.
authors.forename: E
authors.initials: E
authors.lastname: Andres
authors.affiliation: Oroxcell, 102 Avenue Gaston Roussel, Romainville, 93230, France.
authors.forename: M
authors.initials: M
authors.lastname: Barry
authors.affiliation: Oroxcell, 102 Avenue Gaston Roussel, Romainville, 93230, France.
authors.forename: A
authors.initials: A
authors.lastname: Hundt
authors.affiliation: Oroxcell, 102 Avenue Gaston Roussel, Romainville, 93230, France.
authors.forename: C
authors.initials: C
authors.lastname: Dini
authors.affiliation: Laboratory of Toxicology, Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Via G. Balzaretti, 9, 20133, Milan, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Corsini
authors.affiliation: Department of Dermatology, VU University Medical Center, De Boelelaan 1117, 1081 HV, Amsterdam, the Netherlands.|Department of Oral Cell Biology, Academic Center for Dentistry Amsterdam, t.a.v. dienst Afspraken & Informatie, University of Amsterdam and VU University, Postbus 7822, 1081 HV, Amsterdam, the Netherlands.
authors.forename: S
authors.initials: S
authors.lastname: Gibbs
authors.affiliation: 3Rs Management & Consulting ApS, Asavaenget 14, 2800 Kongens, Lyngby, Denmark.
authors.forename: E L
authors.initials: EL
authors.lastname: Roggen
authors.affiliation: Institut De Recherche Pierre Fabre, Recherche et Développement Pierre Fabre Dermo Cosmetique, 3 Avenue Hubert Curien, BP 13562, 31035, Toulouse, France.
authors.forename: P-J
authors.initials: PJ
authors.lastname: Ferret
mesh_terms: D000826:Animal Testing Alternatives; D000818:Animals; D004797:Enzyme-Linked Immunosorbent Assay; D004817:Epidermis / Q000187:drug effects*; D006801:Humans; D020382:Interleukin-18 / Q000378:metabolism*; D007509:Irritants / Q000633:toxicity*
chemical_list: D020382:Interleukin-18; D007509:Irritants
keywords: IL-18; cell culture; reconstructed epidermis; safety testing; sensitization; skin physiology/structure