Comparison between four HET-CAM protocols for aye irritation evaluation of cosmetics products in Argentina

MARTÍN NICOLÁS RIVERO; MARIELA LENZE; MERCEDES IZAGUIRRE; SILVIA PEREZ DAMONTE; SILVIA WIKINSKI; MARÍA LAURA GUTIÉRREZ

Barcelona

Congreso; THE 21st INTERNATIONAL CONGRESS OF THE EUROPEAN SOCIETY OF TOXICOLOGY IN VITRO; 2020

EUROPEAN SOCIETY OF TOXICOLOGY IN VITRO (ESTIV)

There is a worldwide trend to replace animals in toxicological studies for safety testing of cosmetics. The hen?s egg test on chorioallantoic membrane (HET-CAM) is an in vitromodel used for prediction of eye irritation that evaluates hemorrhage, hyperemia/lysisand coagulation as endpoints. There are different HET-CAM protocols widely accepted.Two Endpoint Assessment protocols (EPA), Lüepke and the ICCVAM guideline, and twoReaction Time Methods (RTM), ECVAM DB-ALM Prot. No. 47 and No. 96, were used.With the objective of compare them, 18 cosmetic products (cream, micellar waters,eyelids serum and shampoos) were tested by HET-CAM protocols while simultaneouslythey were evaluated ophthalmologically on volunteers. Products tested were classifiedinto four categories: non irritant, weak, moderate and severe irritant, except for ICCVAMthat discriminates between severe and non-severe.The in vitro results were compared between themselves and correlated with clinicalresults. There was 100% of concordance in the classification of substances as non-irritants, no false negatives were observed. All products that were irritating to humanswere also irritating by all HET-CAM protocols. An 80% accuracy was obtained betweenthe results in vitro and in vivo. The remaining 20% correspond to shampoos that haveamphoteric surfactants in their formulations. However, the ICCVAM protocol was themost accurately predicted the irritation potential for this type of surfactant. Shampooswith non-ionic surfactants were classified as non-irritant or weak irritant by all HET-CAMprotocols, as obtained in volunteers.We conclude that the use of HET-CAM is a reliable method to detect irritation of cosmeticand that ICCVAM method is the one chosen to study products with surfactants. This isthe first work that compares HET-CAM methodologies for cosmetics assessment inArgentina with the objective of consolidating the first laboratory of alternative to animalmethods for toxicity studies.