454. 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. Presented at the 6th World Congress on Alternatives and Animal Use in the Life Sciences, Tokyo, Japan August 21-25, (2007).

Summary:
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.

====================

Request an Electronic Copy (PDF format) of this Technical Paper

====================

EpiOcular Data Sheet

EpiOcular Specifications

EpiOcular Technical References

---

Applications: 7th Amendment Cosmetics Directive, Irritation - eye (ocular), Personal care products, Reproducibility - eye (ocular) tissue model

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

---