Pharmaceutical Testing

Pharmaceutical Testing

In Vitro Tests

The EpiOcularTM (OCL-200-EIT ) is an in vitro hazard assessment assay that has the ability to differentiate materials that are ocular non-irritants from materials that are ocular irritants. The protocol consists of the application of the test substance on a non-keratinized epithelium, prepared from normal human keratinocytes. The ability to expose the tissue topically is essential to model the same kind of progressive injury expected in vivo. It also allows both solid and liquid test materials to be applied directly to tissue. The cell viability after the application is determined via MTT assay. The final determination of cell viability is being conducted using ELISA photometer. A substance is categorized as irritating if the mean cell viability of minimum two under test tissues is below 60% of the negative control.

EpiOcular ET-50 Eye Irritation Test. This in vitro risk assessment assay is based on the effective time at which a material (applied neat) causes a 50% reduction in tissue viability (ET-50). B1ased on the ET-50% the test article is categorized into one of 4 classifications ranging from non-irritating, very mild, mild, moderate to severe/extreme, which correspond to groupings of Rabbit Draize Eye Scores (MMAS).

EpiDerm (EPI-200-SIT). The system consists of the application of the test substance in different conditions on reconstructed human epidermis (RhE). The cell viability after the application is determined via MTT assay. The final determination of cell viability is being conducted using ELISA photometer. A substance is categorized as irritating if the mean cell viability of minimum three under test tissues is below 50% of the negative control.

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