Blazka1, M.E., Harbell2, J.W., Klausner3, M., Raabe2, H., Kubilus3, J., Hsia4, F., Minerath5, B., Bagley1, D.M. 1Colgate-Palmolive Co., Piscataway NJ, 2Institute for In Vitro Sciences, Gaithersburg, MD, 3MatTek Corp., Ashland, MA, 43M Co., St. Paul, MN, 5Kimberly Clark, Neenah, WI.

The objective of this corporate-based program was to formally validate the EpiOcular™ model’s ability to predict the eye irritation potential of surfactants and surfactant-based formulations, As defined by the Interagency Coordinating Committee on the Validation of Alternative Methods (NIH Publication No.97-3981), a validated method is one for which the reliability and relevance for a specific purpose have been established. EpiOcular is a commercially available three-dimensional in vitro model of the human corneal epithelium composed of normal human-derived epidermal keratinocytes. Four laboratories (Institute for In Vitro Sciences, MatTek, 3M and Kimberly Clark) conducted a range finding and three definitive assays on each of 20 blinded materials (6 formulations, 14 surfactants) in compliance with FDA GLPs using a formal and detailed test protocol. EpiOcular results for the test materials were compared to previously published eye irritation studies in animals. In terms of reliability, the results were reproducible within and between the laboratories. In terms of relevance, the EpiOcular model correctly predicted the Draize score for a majority of the samples tested. Results from five of six formulations were in agreement with the in vivo data. In addition, the eye irritation potential for anionic and cationic surfactants was correctly predicted. For those materials not predicted, the majority seemed to be alcohol ethoxylate surfactants that were under-estimated or amphoteric surfactants that were over-estimated for eye irritation. A complete statistical analysis of the data will be presented. These data indicate that, for certain classes of surfactant and surfactant-based formulations, the EpiOcular model has met the critical validation criteria for assessing ocular irritation.


Alcohol ethoxylate surfactants, Amphoteric surfactants, Anionic surfactants, Cationic surfactants, Draize prediction model, Draize scores, Draize tests, EpiDerm, EpiOcular, Eye irritation, Formulation, Ocular irritancy testing, Ocular irritation, Ocular irritation testing, Pre-validation, Prediction model, Prevalidation, Reproducibility, Reproducible, Surfactants, Validation

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