DUNS Number - 67-716-4521  |  NCAGE CODE – 2444Y  |  FDA - FEI – 3014694901


Pharma / Bio Pharma

Crop Care




In vitro Eye Irritation

In vitro Eye Irritation

EpiOcular™ Eye Irritation Test


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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