EpiOcular Eye Irritation Test
TG492
This Test is based on a commercial RhCE-model reconstructed from primary human cells. The RhCE tissues are reconstructed from primary human cells, which have been cultured for several days to form a stratified, highly differentiated squamous epithelium morphologically similar to that found in the human cornea. The EpiOcular RhCE model consists of at least 3 viable layers of cells and a non-keratinized surface, showing a cornea-like structure analogous to that found in vivo. It directly covers an important mechanistic step determining the overall in vivo serious eye damage/eye irritation response of a chemical upon ocular exposure, i.e., cell and tissue damage resulting in localised trauma.
In this study the test chemical is applied topically to a minimum of two three-dimensional RhCE tissues and tissue viability is measured following exposure and a post-treatment incubation period. The measurement of viability of the EpiOcular RhCE tissue after topical exposure to a test chemical to discriminate chemicals not requiring classification for serious eye damage/eye irritancy (UN GHS No Category) from those requiring classification and labelling (UN GHS Categories 1 and 2) is based on the assumption that all chemicals inducing serious eye damage or eye irritation will induce cytotoxicity in the corneal epithelium. RhCE tissue viability in EpiOcular EIT is measured by enzymatic conversion of the vital dye MTT into a blue MTT formazan salt that is quantitatively measured after extraction from tissues.
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