Back In vitro test approach

AUTHORS : Alepee N. Amsellem Carole Bertino Beatrice Bremond Christelle Capallere Christophe Cotovio J de Brugerolle de Fraissinette A. Grandidier M H Leclaire J Lelièvre D Loisel-Joubert Sophie Maloug Saber Meunier Jean-Roch Minondo Anne-Marie Ovigne Jean-Marc Tinois-Tessonneaud Estelle Van Der Lee Aline

MODELS : HCE / HUMAN CORNEAL EPITHELIUM

2009
SkinEthic

In vitro assessment of eye irritancy using the Reconstructed Human Corneal Epithelial SkinEthic™ HCE model: Application to 435 substances from consumer products industry

The 7th amendment of the EU Cosmetics Directive led to the ban of eye irritation testing for cosmeticingredients in animals, effective from March 11th 2009. Over the last 20 years, many efforts have beenmade to find reliable and relevant alternative methods. The SkinEthic™ HCE model was used to evaluatethe based on a specific 1-h treatment and a 16-h post-treatment incubation period was first assessed on a setof 102 substances. The prediction model (PM) based on a 50% viability cut-off, allowed to draw up twoclasses (Irritants and Non-Irritants), with good associated sensitivity (86.2%) and specificity (83.5%). Tocheck the robustness of the method, the evaluated set was expanded up to 435 substances. Final performancesmaintained a high level and were characterized by an overall accuracy value > 82% when usingEU or GHS classification rules. Results showed that the SkinEthic™ HCE test method is a promising in vitro eye irritancy potential of substances from a cosmetic industry portfolio. An optimized protocolin vitrotool for the prediction of eye irritancy. Optimization datasets were shared with the COLIPA Eye IrritationProject Team and ECVAM experts, and reviewed as part of an ongoing progression to enter an ECVAMprospective validation study for eye irritation.