title: Prospective multicentre study of the U-SENS test method for skin sensitization testing.
abstract: The U-SENS™ is a test method based on the human myeloid U937 cell line to assess the skin sensitisation potential of substances. To demonstrate its robustness, a multicentre validation study with four laboratories testing 24 coded substances has been conducted according to internationally agreed principles. The primary objective of the study was to enlarge the U-SENS™'s reproducibility database. Secondary objectives were to provide additional evidence on its transferability and its predictive capability. Reproducibility within laboratories was approximately 92%, while the reproducibility between laboratories was 87.5%. Predictivity for the 24 validation substances was high, with sensitivity, specificity and accuracy being on average at least 93.8%. Similar performances are obtained for 38 substances when combining the study results with those of an earlier multicentre study, as well as with an automated version of the U-SENS™. With reliability and relevance similar to comparable non-animal skin sensitisation test methods, which have achieved regulatory acceptance, it is concluded that the U-SENS™ is a well reproducible and predictive test method. This profiles the U-SENS™ as a valuable addition to the suite of non-animal testing methods for skin sensitisation with the potential to significantly contribute to the development of integrated testing strategies.
authors.affiliation: L'Oréal R&I, Aulnay Sous Bois, France. Electronic address: nalepee@rd.loreal.com.
authors.forename: N
authors.initials: N
authors.lastname: Alépée
authors.affiliation: L'Oréal R&I, Aulnay Sous Bois, France.
authors.forename: C
authors.initials: C
authors.lastname: Piroird
authors.affiliation: WIL Research Europe - Lyon, Saint-Germain-Nuelles, France.
authors.forename: M
authors.initials: M
authors.lastname: Aujoulat
authors.affiliation: Episkin SA, Lyon, France.
authors.forename: S
authors.initials: S
authors.lastname: Dreyfuss
authors.affiliation: Seh Consulting+Services, Paderborn, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Hoffmann
authors.affiliation: Bioassay GmbH, Heidelberg, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Hohenstein
authors.affiliation: VitroScreen, Milano, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Meloni
authors.affiliation: L'Oréal R&I, Aulnay Sous Bois, France.
authors.forename: L
authors.initials: L
authors.lastname: Nardelli
authors.affiliation: CiToxLAB, Evreux, France.
authors.forename: C
authors.initials: C
authors.lastname: Gerbeix
authors.affiliation: L'Oréal R&I, Aulnay Sous Bois, France.
authors.forename: J
authors.initials: J
authors.lastname: Cotovio
mesh_terms: D000826:Animal Testing Alternatives; D006801:Humans; D011446:Prospective Studies; D015203:Reproducibility of Results; D012867:Skin / Q000187:drug effects*; D012882:Skin Tests; D018675:Toxicity Tests / Q000379:methods*; D020298:U937 Cells
keywords: In vitro test method; Predictivity; Reproducibility; Skin sensitisation; U-SENS™; Validation