title: SENS-IS, a 3D reconstituted epidermis based model for quantifying chemical sensitization potency: Reproducibility and predictivity results from an inter-laboratory study.
abstract: The SENS-IS test protocol for the in vitro detection of sensitizers is based on a reconstructed human skin model (Episkin) as the test system and on the analysis of the expression of a large panel of genes. Its excellent performance was initially demonstrated with a limited set of test chemicals. Further studies (described here) were organized to confirm these preliminary results and to obtain a detailed statistical analysis of the predictive capacity of the assay. A ring-study was thus organized and performed within three laboratories, using a test set of 19 blind coded chemicals. Data analysis indicated that the assay is robust, easily transferable and offers high predictivity and excellent within- and between-laboratories reproducibility. To further evaluate the predictivity of the test protocol according to Cooper statistics a comprehensive test set of 150 chemicals was then analyzed. Again, data analysis confirmed the excellent capacity of the SENS-IS assay for predicting both hazard and potency characteristics, confirming that this assay should be considered as a serious alternative to the available in vivo sensitization tests.
authors.affiliation: ImmunoSearch, Grasse, France.
authors.forename: Françoise
authors.initials: F
authors.lastname: Cottrez
authors.affiliation: ImmunoSearch, Grasse, France.
authors.forename: Elodie
authors.initials: E
authors.lastname: Boitel
authors.affiliation: Agence nationale de sécurité du médicament, Vendargues, France.
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Ourlin
authors.affiliation: Agence nationale de sécurité du médicament, Vendargues, France.
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Peiffer
authors.affiliation: Agence nationale de sécurité du médicament, Vendargues, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Fabre
authors.affiliation: CNRS, Institute of Molecular and Cellular Pharmacology, Sophia Antipolis, France; University of Nice Sophia Antipolis, Nice, France.
authors.forename: Imène-Sarah
authors.initials: IS
authors.lastname: Henaoui
authors.affiliation: CNRS, Institute of Molecular and Cellular Pharmacology, Sophia Antipolis, France; University of Nice Sophia Antipolis, Nice, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Mari
authors.affiliation: CNRS, Institute of Molecular and Cellular Pharmacology, Sophia Antipolis, France; University of Nice Sophia Antipolis, Nice, France.
authors.forename: Ambre
authors.initials: A
authors.lastname: Vallauri
authors.affiliation: CNRS, Institute of Molecular and Cellular Pharmacology, Sophia Antipolis, France; University of Nice Sophia Antipolis, Nice, France.
authors.forename: Agnes
authors.initials: A
authors.lastname: Paquet
authors.affiliation: CNRS, Institute of Molecular and Cellular Pharmacology, Sophia Antipolis, France; University of Nice Sophia Antipolis, Nice, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Barbry
authors.affiliation: ImmunoSearch, Grasse, France.
authors.forename: Claude
authors.initials: C
authors.lastname: Auriault
authors.affiliation: Independant Consultant, Marly, Switzerland.
authors.forename: Pierre
authors.initials: P
authors.lastname: Aeby
authors.affiliation: ImmunoSearch, Grasse, France. Electronic address: hgroux@immunosearch.fr.
authors.forename: Hervé
authors.initials: H
authors.lastname: Groux
mesh_terms: D000485:Allergens / Q000633:toxicity*; D000826:Animal Testing Alternatives; D003877:Dermatitis, Contact; D004817:Epidermis / Q000187:drug effects*; D015870:Gene Expression / Q000187:drug effects; D006801:Humans; D066298:In Vitro Techniques; D007753:Laboratories; D008954:Models, Biological; D015203:Reproducibility of Results
chemical_list: D000485:Allergens
keywords: Alternatives to animal tests; Reconstituted epidermis; SENS-IS; Skin sensitization; Toxicogenomics