OECD procedure 492 describes an in vitro procedure that allows the identification of chemicals (substances and compounds) that do not require classification and labeling for eye irritation or serious eye damage. This method uses reconstructed human corneal-like epithelium (RhCE), which closely mimics the histological, morphological, biochemical and physiological properties of human corneal epithelium. This test method evaluates the ability of a test chemical to induce cytotoxicity in a RhCE tissue construct. Colored chemicals are also tested using a high performance liquid chromatography (HPLC) procedure.
RhCE tissue viability following exposure to a test chemical is measured by the viable cells of the tissues by enzymatic conversion of the vital dye to a blue formazan salt, which is quantified after extraction from the tissues. The viability of RhCE tissue is determined compared to tissue treated with the negative control substance and then used to estimate the eye-damaging potential of the test chemical. Chemicals that do not require classification and labeling are defined as those that do not reduce tissue viability below a defined threshold (ie, tissue viability 60 percent).
Four validated test methods using commercially available human corneal-like epithelium (RhCE) models are included in this OECT procedure 492.
A wide variety of raw materials and formulations come into contact with the eyes, hence the need for this regulatory in vitro eye irritation test. Many manufacturers use this procedure for hazard identification and labeling purposes to comply with a number of regulations, most notably REACH. This procedure is approved for chemicals that do not require classification and labeling for eye irritation or serious eye damage.
Our organization has been restructured to identify chemicals that do not require classification and labeling for eye irritation or serious eye damage, within the scope of OECD Procedure 492, with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it has given for businesses in various sectors. It also provides human corneal-like epithelium (RhCE) testing services.
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