Safety Study of Hypoallergenic Mascara for Human Eyes

ABSTRACT

We performed in vitro tests, experiments on rabbits and clinical trials to treat dermatologic and ocular irritation using mascaras with different ratios of components. Two kinds of mascaras with high concentration of polymers caused moderately severe vascular constriction in the chorioallantoic membrane(CAM) vascular assay and showed significant conjunctival injection and eye discharge following instillation on rabbits' eyes compared to low concentration of polymers. There was no significant difference in the skin reactions caused by mascara with a low concentration of polymers of which safety was confirmed by using above tests and repeat insult patch test involving 20 adult females. Hypoallergenic mascara with a low concentration of polymers showed no subjective symptoms but mild rashes on lids appeared in 1 case, conjunctival injection in 3 cases and corneal erosions in 4 cases among the 40 female adult subjects including 8 contact lens wearers. However the cases improved spontaneously without any treatment. There was no statistically significant change of tear break-up time(BUT) between contact lens wearers and non wearers for both before and after mascara use(P>0.05). In this study, it has been confirmed that the new mascara is safe in animal experiments for ocular irritation and CAM vascular assay as well as human patch test for contact allergy revealed the safety as a ocular cosmetic.