THE UTILIZATION OF THE EPIOCULAR HUMAN TISSUE MODEL TO ASSESS AND COMPARE THE IRRITATION POTENTIAL OF MULTIPLE SURFACTANT SYSTEMS USED IN SHAMPOOS AND FACIAL CLEANSERS.

This study by scientists at Alberto-Culver Company and the Institute for In Vitro Sciences demonstrated that MatTek’s EpiOcular in vitro human corneal tissue equivalent is an excellent in vitro model for performing the ocular safety evaluation of multiple surfactant systems used in shampoos and facial cleansers. Assuring the safety of cosmetics and personal care products without testing in animals is a primary goal for Alberto-Culver Company. In addition, the Seventh Amendment to the Cosmetics Directive requires that after 2009, animal testing cannot be used to assess the eye or skin irritation potential of either cosmetic formulations or ingredients. To address these issues, scientists at Alberto-Culver and the Institute for In Vitro Sciences (IIVS) have developed an in vitro irritation assessment program to support the ocular safety evaluation of multiple surfactant systems used in shampoos and facial cleansers. This is particularly important as eye irritation is a foreseeable occurrence in the use of these cosmetics and personal care products. The program relies on the results of a topical application of formulations to the surface of a three-dimensional, human cell-derived model of the corneal epithelium (EpiOcular™, MatTek Corp., Ashland, MA, USA) and monitoring time to toxicity. 35 finished products and 15 prototype formulations with a range of multiple surfactant systems have been tested at dilutions of 2% and 10% (w/v in water). Two surfactant reference standards with well established safety profiles in commerce were tested along with these materials at same dilutions of 2% and 10%. The irritation potential of materials was then assessed by comparison to these benchmark materials. At these dilutions, we determined that the irritancy potential for most of the prototype shampoos fell in the mild to no irritation range shown as similar and less cytotoxic responses compared to the Reference materials. The effectiveness of this in vitro test system was evaluated by comparing the in vitro test results with consumer experience information. All products tested using the program outlined herein and based on the in vitro EpiOcular assay were predicted to fall in the mild to no irritation range based on the existing prediction model and by comparison with the Reference materials. As expected, the ET-50 values obtained for the 10% dilutions of the test articles were shorter (showed greater cytotoxicity) as compared to the values obtained when 2% dilutions were used. The cytotoxicity results of the test materials can still be compared since the Reference materials were tested along with the test materials at 2% and 10% dilutions. The positive control ET-50 results in EpiOcular tissue were reproducible and consistent with results from previous studies over the last decade. This is important because it implies the model will provide the stable platform needed when a long term in vitro testing program is being envisioned.

Body washes, EpiOcular, Facial cleansers, MTT, MTT tissue viability, Multiple surfactant systems, OCL-200, Seventh amendment to the cosmetics directive, Shampoos

Ammonium Laureth Suifate , Ammonium Lauryl Sulfate , Cocamide DEA , Cocamidopropyl Betaine, Decyl Glucoside , Disodium 2Sulfolaurate , Potassium Laureth Phosphate, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Sodium Lauryl Sulfoacetate, Sodium Methyl Sulfolaurate