COMPARISON BETWEEN HET-CAM PROTOCOLS AND A PRODUCT USE CLINICAL STUDY FOR EYE IRRITATION EVALUATION OF PERSONAL CARE PRODUCTS ACCORDING TO THEIR SURFACTANT COMPOSITION

RIVERO, MARTIN NICOLAS; LENZE, MARIELA; IZAGUIRRE, MERCEDES; BENEDETTI, MARTINA; PEREZ DAMONTE, SILVIA; WIKINSKI, SILVIA; GUTIÉRREZ, MARÍA LAURA

Barcelona

Congreso; 21st International Congress ESTIV; 2022

European Society of In Vitro Toxicology

The hen’s egg test on chorioallantoic membrane (HET-CAM) is one of the most frequentlyused alternative tests for prediction of ocular irritation of cosmetic products. There aredifferent HET-CAM protocols widely accepted, but there is no information about which ofthe protocols better correlates with the results obtained in product use clinical studyunder the conditions of use.Two Fix Time Methods (FTM) -Lüepke and the ICCVAM guideline - and two Reaction TimeMethods (RTM) -ECVAM DBALM Prot. No. 47 and No. 96- were employed to test 18cosmetic products. Simultaneously, they were evaluated by an ophthalmological clinicaltest. A unified classification system was used, and products were classified into fourirritation levels: non-irritant, weak, moderate and severe irritant.The duration of use (rinse-off or leave-on), and the concentration and type of surfactantswere taken into account in the analysis. All the products that were classified as nonirritantby any HET-CAM protocols were also safe in the product use clinical study. Theproduct that was found to be non-safe in the product use clinical evaluation was alsounsuitable by most of the HET-CAM protocols.All protocols resulted appropriate to evaluate 10% dilutions of rinse-off products with ahigh content of non-ionic surfactants as shampoos. However, HET-CAM is notrecommended to test products containing high concentration of anionic and cationicsurfactants due to the highly irritating reaction obtained.These results were employed to develop an algorithm that allows selecting theappropriate HET-CAM protocol for each type of product to be tested. Applying thealgorithm, a protocol is chosen taking into account the following points: 1-weight of theevidence, 2- duration of use, 3- surfactant concentration and 4- surfactant type.