Blazka, M.E., Harbell1, J.W., Klausner2, M., Raabe1, H., Kubilus2, J., Hsia3, F., Minerath4, B., Bagley, D.M. Colgate-Palmolive, Piscataway, NJ, USA, 1Institute for In Vitro Sciences, Gaithersburg, MD, USA, 2MatTek, Corp. Ashland, MA, USA, 33M, St Paul, MN, USA, 4Kimberly Clark, Neenah, WI, USA.

Currently, no alternative to the Draize eye test has been validated and ac-cepted by any regulatory body. The objective of this corporate-based programme was to formally validate the EpiOcular™ model’s ability to predict the eye irritation potential of surfactants and surfactant-based formulations. Developed by MatTek, EpiOcular is a three-dimensional organotypic model of the human corneal epithelium composed of normal human keratinocytes. The EpiOcular model uses the exposure time required to reduce the tissue viability to 50% (ET50) to predict the Draize Modified Maximum Average Score (MMAS) using the algorithm: Draize MMAS = -4.74 + 101.7 √ET50, where ET50 is 1 ≤ ET50 ≤ 240 minutes. The validation programme was developed in accordance with criteria established by the Interagency Coordinating Committee on the Validation of Alternative Methods (NIH Publication No.97-3981). During the prevalidation phase of the programme, the prediction model was developed, the protocol was finalised, test materials meeting programme criteria were obtained, and participating laboratories were qualified. Testing was conducted in compliance with FDA Good Laboratory Practice regulations. Laboratories that participated in the programme included the Institute for In Vitro Sciences, MatTek, 3M and Kimberly Clark. Criteria for test material inclusion were that good quality historical animal data were available, and that the materials were either surfactants or surfactant-based formulations. During the validation phase, test sites conducted a rangefinder and three definitive assays on each of 20 blind tested materials (6 formulations, 14 surfactants).


EpiOcular, Eye irritation, ICCVAM, Interagency Coordinating Committee on the Validation of Alternative Methods, Ocular irritancy testing, Ocular irritation, Ocular irritation testing, Pre-validation, Prevalidation, Surfactants, Validation, Validation of Alternative Methods

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