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EPIOCULAR™ PREDICTION MODEL. A REPRODUCIBLE IN VITRO TISSUE CULTURE MEANS OF PREDICTING DRAIZE SCORES.
Kubilus, J., Sennott, H., Makwana, A., Klausner, M.
MatTek Corp., Ashland, MA.
The Toxicologist, 36 (1), 44, Soc. of Toxicol. (Reston, VA), Abstract #222, (1997).
Keywords: Basal cells, Corneal epithelium, Corneal epithelium models, Cosmetics, Cytotoxicity, Draize prediction model, Draize scores, Draize tests, Endpoints, MTT, EpiOcular, Eye irritation, MTT, MTT ET-50 tissue viability assay, MTT assay, Ocular irritancy testing, Ocular irritation, Ocular irritation testing, Personal care products, Pre-validation, Prediction model, Prevalidation, Reproducibility, Reproducible, Shampoo(s), Surfactants, Surfactants, irritancy, Surfactants, irritancy potential, Validation
Summary: The EpiOcular™ tissue model (OCL-200) is an organotypic model of the human corneal epithelium (HCE) cultured from normal human keratinocytes using serum free medium. Parafin embedded, H&E stained histology cross-sections show the structure of EpiOcular closely parallels that of the HCE; large nucleated basal cells lie beneath 5-6 stratified cell layers which progressively flatten out, ending with a highly squamous, non-keratinized layer at the culture’s apical surface. Using the MTT ET-50 cytotoxicity assay, 28 materials from the ECETOC ocular database were tested with the OCL-200 and the in vitro results were correlated to the Draize scores available from the data base; a linear plot of log ET-50 versus log Draize gave a correlation coefficient, r = 0.90. This correlation was then used to develop the “prediction model” from which a Draize score could be calculated based on an ET-50. To probe the utility of the prediction model, 33 materials including surfactants, final formulation shampoos, and off-the-shelf cosmetic products for which Draize data were available, were tested. The predicted and actual Draize scores were compared and a resulting correlation coefficient of r = 0.85 was obtained. Thus, the EpiOcular tissue model appears to be a facile, in vitro means to reduce and/or replace in vivo, animal-based ocular irritancy testing.
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