title: In vitro assessment of eye irritancy using the Reconstructed Human Corneal Epithelial SkinEthic HCE model: application to 435 substances from consumer products industry.
abstract: The 7th amendment of the EU Cosmetics Directive led to the ban of eye irritation testing for cosmetic ingredients in animals, effective from March 11th 2009. Over the last 20years, many efforts have been made to find reliable and relevant alternative methods. The SkinEthic HCE model was used to evaluate the in vitro eye irritancy potential of substances from a cosmetic industry portfolio. An optimized protocol based on a specific 1-h treatment and a 16-h post-treatment incubation period was first assessed on a set of 102 substances. The prediction model (PM) based on a 50% viability cut-off, allowed to draw up two classes (Irritants and Non-Irritants), with good associated sensitivity (86.2%) and specificity (83.5%). To check the robustness of the method, the evaluated set was expanded up to 435 substances. Final performances maintained a high level and were characterized by an overall accuracy value > 82% when using EU or GHS classification rules. Results showed that the SkinEthic HCE test method is a promising in vitro tool for the prediction of eye irritancy. Optimization datasets were shared with the COLIPA Eye Irritation Project Team and ECVAM experts, and reviewed as part of an ongoing progression to enter an ECVAM prospective validation study for eye irritation.
authors.affiliation: L'OREAL Research, 1 Avenue Eugène Schueller, 93600 Aulnay Sous Bois, France. jcotovio@rd.loreal.com
authors.forename: José
authors.initials: J
authors.lastname: Cotovio
authors.forename: Marie-Hélène
authors.initials: MH
authors.lastname: Grandidier
authors.forename: Damien
authors.initials: D
authors.lastname: Lelièvre
authors.forename: Christelle
authors.initials: C
authors.lastname: Bremond
authors.forename: Carolle
authors.initials: C
authors.lastname: Amsellem
authors.forename: Saber
authors.initials: S
authors.lastname: Maloug
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Ovigne
authors.forename: Sophie
authors.initials: S
authors.lastname: Loisel-Joubert
authors.forename: Aline Van Der
authors.initials: AV
authors.lastname: Lee
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Minondo
authors.forename: Christophe
authors.initials: C
authors.lastname: Capallere
authors.forename: Béatrice
authors.initials: B
authors.lastname: Bertino
authors.forename: Nathalie
authors.initials: N
authors.lastname: Alépée
authors.forename: Estelle
authors.initials: E
authors.lastname: Tinois-Tessonneaud
authors.forename: Anne De Brugerolle
authors.initials: Ade B
authors.lastname: de Fraissinette
authors.forename: Jean-Roch
authors.initials: JR
authors.lastname: Meunier
authors.forename: Jacques
authors.initials: J
authors.lastname: Leclaire
mesh_terms: D000826:Animal Testing Alternatives; D003358:Cosmetics / Q000633:toxicity*; D019573:Epithelium, Corneal / Q000187:drug effects*; D006801:Humans; D007509:Irritants / Q000633:toxicity*; D011237:Predictive Value of Tests; D023382:Toxicity Tests, Acute / Q000379:methods*
chemical_list: D003358:Cosmetics; D007509:Irritants