PREDICTION OF OCULAR IRRITATION POTENTIAL OF SURFACTANTS-BASED FORMULATIONS AT DIFFERENT CONCENTRATIONS USING THE EPIOCULAR MODEL.

This study by scientists at Mary Kay, Inc. demonstrated that MatTek’s EpiOcular in vitro human corneal tissue equivalent was able to distinguish between the sensory discomfort levels of 2 surfactants-based facial cleansers at specific concentrations in addition to accurately predicting the ocular irritation potential of these personal care products. Evaluating ocular irritation is essential to the safety assessment of facial and eye-area cosmetics. The EpiOcular™ tissue construct model has been developed and used extensively to predict the traditional eye irritation potential end-points of those products used around the eye area. Sensory discomfort to the mucus membranes and skin tissues around the eye is also an important factor in consumer acceptance of these products. The current study investigated whether the concentration tested in the EpiOcular tissue construct model affects its ability to distinguish the degree of sensory discomfort potential to the eye area. Two surfactants-based facial cleanser formulations (Fd and Fm) were tested using the EpiOcular assay and the results were compared with data obtained from clinical and consumer studies. At a concentration of 3%, Fm was shown to have a significantly shorter ET50 (duration of exposure causing a 50% decrease in tissue viability) than Fd, whereas no difference between the ET50 was found when both were tested at 10%. The eye irritation potential of the two formulations was also investigated through clinical evaluations by direct ocular instillation of a 1% solution. Fm was shown to cause a greater frequency and magnitude of sensory eye irritation than Fd. By contrast, objective ophthalmic examinations including ocular surface fluorescein staining failed to reveal any difference between the two treatments. Indeed, no evidence of ocular irritation or other adverse effects were observed at the same time. Ocular discomfort caused by Fm was also noted in a consumer use study where panelists used the two cleansers for 12 weeks. Markedly increased frequency and magnitude of sensory eye irritation from using Fm in consumer panelists were noted, while Fd did not cause any sensory eye irritation. These results indicate that use of relatively low test article concentrations for eye area products may allow the EpiOcular assay to better distinguish the degree of sensory discomfort of surfactants-based formulations. The results further suggest that, in addition to predicting objective ocular irritation potential of various cosmetic ingredients and finished products, the EpiOcular tissue construct model may also have predictive value in sensory eye irritation potential of these materials.

EpiOcular, Facial cleanser, Ocular irritation, Safety assessment, Sensory discomfort level, Sensory eye irritation potential, Surfactants-based formulations, Surfactants-based products