DEMONSTRATING THE OCULAR SAFETY OF AN EYE COSMETIC PRODUCT USING ALTERNATIVES TO ANIMAL EYE IRRITATION TESTS.

Previous studies have reported the use of the Tissue Equivalent Assay (TEA) and clinical eye irritation tests for assessing the ocular safety of various consumer products. In lieu of rabbit eye irritation testing, a tiered approach was employed to assess the ocular safety of a new mascara formula. After review of available ingredient eye irritation data, several new formulas and marketed benchmark mascaras were evaluated in an extended TEA (maximum 24 hr exposure) by scientists at Procter & Gamble Company, Microbiological Associates, Inc. and Clinical Research Laboratories, Inc. The TEA identified those new formulas which would have low eye irritation potential in humans, as compared to a broad range of prototype and marketed mascaras previously evaluated in the extended TEA. One mascara prototype (A) with a low eye irritation potential as determined by the TEA and two safely marketed benchmark mascaras (X and Y) were then evaluated in a 28-day safety in-use test with self-assessed sensitive and non-sensitive human subjects as well as contact lens wearers under the direction of a Board Certified ophthalmologist. A novel grading system (scale of 0-13) was employed for fluorescein staining of conjunctival, corneal, and caruncular tissues. Additionally, the tear film break-up time was measured for each subject. Sensory reaction assessments were provided by the subjects at each exam time and via diaries. The results demonstrated that mascaras A, X, and Y were equally safe for consumer use. The minimal, transient eye effects observed were non-product related and clinically non-significant. Consumer exposure data further supported the in vitro and clinical results. This research provides additional confirmation that a combination of the TEA and clinical tests can be used successfully for ocular safety assessment of cosmetic products.

Corneal epithelium, Corneal epithelium models, Cosmetic Personal Care Products, Mascara, EpiOcular, Eye irritation, Mascara, Ocular irritancy testing, Ocular irritation, Ocular irritation testing, Safety, ocular