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 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.
Cotovio
José
J
L'OREAL Research, 1 Avenue Eugène Schueller, 93600 Aulnay Sous Bois, France. jcotovio@rd.loreal.com
Grandidier
Marie-Hélène
MH
Lelièvre
Damien
D
Bremond
Christelle
C
Amsellem
Carolle
C
Maloug
Saber
S
Ovigne
Jean-Marc
JM
Loisel-Joubert
Sophie
S
Lee
Aline Van Der
AV
Minondo
Anne-Marie
AM
Capallere
Christophe
C
Bertino
Béatrice
B
Alépée
Nathalie
N
Tinois-Tessonneaud
Estelle
E
de Fraissinette
Anne De Brugerolle
Ade B
Meunier
Jean-Roch
JR
Leclaire
Jacques
J
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*
D003358:Cosmetics; D007509:Irritants