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EXPERIENCES IN THE DEVELOPMENT AND UTILIZATION OF AN IN VITRO SAFETY TESTING PROGRAM FOR HAIR CONDITIONERS.

Vavilikolanu1, P., Lazaro1, C., Mun2, G., Hilberer2, A., Hyder2, M., Raabe2, H., and Curren2, R. 1Alberto-Culver Company, Melrose Park, IL, USA, 2Institute for In Vitro Sciences, Inc., Gaithersburg, MD, USA.
Abstract

This study by scientists at Alberto-Culver Co. and the Institute for In Vitro Sciences (IIVS) demonstrated that major personal care and cosmetics companies are basing their internal ocular product safety evaluation programs on MatTek’s EpiOcular in vitro human corneal tissue equivalent as a reliable replacement for animal-based studies. Assuring the safety of cosmetics and personal care products without testing in animals has long been the goal of many international companies. This concern has become even more important with the requirement of the Seventh Amendment to the Cosmetics Directive that after 2009 animal testing cannot be used to assess the eye or skin irritation potential of either cosmetics formulations or ingredients. To address this problem, the Alberto-Culver Company has developed a program to support the ocular safety evaluation of certain hair conditioners. This 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. Over thirty different formulations, primarily based on either single or dual quaternary ammonium compound systems, have been evaluated in the model. The vast majority of the materials had ET’s of close to 24 hours, indicating that they were quite mild. The effectiveness of the system has been assessed by comparing the 50 in vitro results with consumer experience information. Further studies with other personal care product groups are in progress.

Keywords

Consumer adverse experience, Cosmetics directive, ET-50, EpiOcular, Freeze-killed tissue, Hair conditioning products, Long-term reproducibility, MTT, Mildness, OCL-200, Ocular irritation, Quarternium ammonium agents, Quarternium ammonium salt systems, Quaternary ammonium compounds, Quaternary ammonium salts

Materials Tested

Centrimonium Chloride, Cocamidopropyl PG-Dimonium Chloride Phosphate, Isotearamidopropyl Ethyldimonium Ethosulfate, Quaternium-18, Quaternium-80, Stearalkonium Chloride

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