159. THE EYE IRRITATION TESTING OF THE ORGANIC SOLVENTS ON IN VITRO TEST USING 3-D CORNEAL MODEL.

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Akaza, N., Kojima, H., Katada. T., Konishi, H. Research Institute, Nippon Menard Cosmetic Co., Ltd. Presented at 12th Annual Meeting of the Japanese Society for Alternatives to Animal Experiments, Sendai, Japan, November 18-19, (1998).

Summary: It has been reported that many in vitro test alternatives to the Draise eye irritation testing (Draize test) are able to evaluate irritation due to surfactants, but not organic solvents. We therefore examined an in vitro test using a 3-D corneal model as an alternative to the Draize test mainly to evaluate irritation caused by organic solvents.
Sodium dodecyl sulfate (SDS), acetone, formalin, ethanol, 1-butanol, iso-propyl alcohol, propylene glycol, glycerin, toluene, methyl ethyl ketone, ethyl acetate and methyl acetate are chosen as test compounds.
We performed MTT assays using "EpiOcular™ tissue model (OCL-200)". MTT data (percentage of untreated control values) were plotted as time-response graphs and rough Time-50 values were obtained by interpolation at the 50% response level, and compared with the results for Draize eye scores from our Research Institute or the ECETOC data base.
The Time-50s for SDS, acetone and formalin at various doses were dose-dependently decreased patterns resembling dose-dependent curves for Draize eye scores. These results show that in vitro testing using the 3-D corneal model is a reliable approach. Furthermore, comparison of the in vitro irritation caused by the organic solvents gave a far better correlation to the Draize eye score than other in vitro test alternatives.
We therefore consider that in vitro test using 3-D corneal model is useful as a screening test to evaluate eye irritation by organic solvents.

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Applications: Irritation - eye (ocular), Validation - in vitro tissue models

Keywords: 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, Pre-validation, Prediction model, Prevalidation, Sodium dodecyl sulfate (SDS), Solvents, organic, Surfactants, Surfactants, irritancy, Surfactants, irritancy potential, Validation

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