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The in vitro macromolecular test method is a biochemical in vitro test method that can be used to identify chemicals (substances and mixtures) that have the potential to induce serious eye damage as well as chemicals not requiring classification for eye irritation or serious eye damage.
This Test Guideline describes a cytotoxicity-based in vitro assay that is performed on a confluent monolayer of Statens Seruminstitut Rabbit Cornea (SIRC) cells, cultured on a 96-well polycarbonate microplate.
This Test Guideline proposes defined approaches (DA) combining data generated in vitro methods, with information sources such as physicochemical properties.
The Isolated Chicken Eye Test (ICE) Method is an in vitro test method that can be used to identify chemicals (substances or mixtures) as either 1) causing “serious eye damage” (category 1 of the Globally Harmonised System for the Classification and ...
The Bovine Corneal Opacity and Permeability test method (BCOP) is an in vitro test method that can be used to identify chemicals (substances or mixtures) as either 1) causing “serious eye damage” (category 1 of the Globally Harmonised System for the Classification and Labelling of chemicals (GHS)), or 2) not requiring classification for eye irritation or serious eye damage according to the GHS.
The Vitrigel-Eye Irritancy Test (EIT) method is an in vitro test method that allows the identification of test chemicals not requiring classification and labelling for eye irritation or serious eye damage. This test measures the eye irritation potential of a test chemical based on its ability to induce damage to the barrier function of the human corneal epithelium (hCE) models used in the Vitrigel-EIT method. It is known that chemicals that are irritating to the eye first destroy tear film and epithelial barrier function of the eye, subsequently induce epithelial cell death, and finally produce stromal degeneration and endothelial cell death, resulting in corneal opacity. Therefore, the change of the epithelial barrier function is a relevant endpoint for detecting eye irritation. In the Vitrigel Eye Irritancy test method , time-dependent changes in the Transepithelial Electrical Resistance (TEER) values are indicative of damage to the barrier function of the corneal epithelium following exposure to a test chemical; this situation is similar to the observed damage of the rabbit cornea following exposure to a test chemical, which is an important mode of action leading to damage of the corneal epithelium and eye irritation. The Vitrigel-Eye Irritancy Test (EIT) method can be used within the limited applicability domain of test chemicals having pH > 5.0 (based on 2.5% weight/volume (w/v) preparation).
This Test Guideline describes an in vitro procedure the identification on its own of chemicals (substances and mixtures) not requiring classification (No Cat), requiring classification for eye irritation (Cat 2) and requiring classification for serious eye damage (Cat 1) according to the UN GHS ocular hazard categories. It makes use of reconstructed human cornea-like epithelium (RhCE) which closely mimics the histological, morphological, biochemical and physiological properties of the human corneal epithelium.
This method provides information on health hazard likely to arise from exposure to test substance (liquids, solids and aerosols) by application on the eye. This Test Guideline is intended preferably for use with albino rabbit. The test substance is ...
This Test Guideline describes a cytotoxicity-based in vitro assay that is performed on a confluent monolayer of Statens Seruminstitut Rabbit Cornea (SIRC) cells, cultured on a 96-well polycarbonate microplate. After five-minute exposure to a test chemical, the cytotoxicity is quantitatively measured as the relative viability of SIRC cells using the MTT assay. Decreased cell viability is used to predict potential adverse effects leading to ocular damage. Cell viability is assessed by the quantitative measurement, after extraction from the cells, of blue formazan salt produced by the living cells by enzymatic conversion of the vital dye MTT, also known as Thiazolyl Blue Tetrazolium Bromide. The obtained cell viability is compared to the solvent control (relative viability) and used to estimate the potential eye hazard of the test chemical. A test chemical is classified as UN GHS Category 1 when both the 5% and 0.05% concentrations result in a cell viability smaller than or equal to (≤) 70%. Conversely, a chemical is predicted as UN GHS No Category when both 5% and 0.05% concentrations result in a cell viability higher than (>) 70%.
This Test Guideline describes an in vitro assay that may be used for identifying water soluble ocular corrosives and severe irritants as defined by the UN Globally Harmonized System of Classification and Labelling, Category 1. The assay is performed ...