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EC number: 701-354-5 | CAS number: -
Individual and Mean Corneal Opacity and Permeability Measurements
In Vitro Irritancy Score
Post-Incubation - Pre‑Treatment
OD= Optical density * = Mean of the post-incubation -pre‑treatment values ¨= Mean permeability ·= Mean corrected value
Corneal Epithelium Condition Post Treatment and Post Incubation
The purpose of this test was to identify test items that can induce serious eye damage and to identify test items not requiring classification for eye irritation or serious eye damage. The Bovine Corneal Opacity and Permeability (BCOP) test method is an organotypic model that provides short‑term maintenance of normal physiological and biochemical function of the bovine cornea in vitro. In this test method, damage by the test item is assessed by quantitative measurements of changes in corneal opacity and permeability.
The test method can correctly identify test items (both chemicals and mixtures) inducing serious eye damage as well as those not requiring classification for eye irritation or serious eye damage, as defined by the United Nations (UN) Globally Harmonized System of Classification and Labelling of Items (GHS) and EU Classification, Labelling and Packaging (CLP) of chemicals (Regulation (EC) No 1272/2008), and it was therefore endorsed as scientifically valid for both purposes. Test items inducing serious eye damage are classified as UN GHS and EU CLP Category 1. Items not classified for eye irritation or serious eye damage are defined as those that do not meet the requirements for classification as UN GHS/EU CLP Category 1 or 2 (2A or 2B), i.e. they are referred to as UN GHS/EU CLP No Category.
The test item was applied at a concentration of 10% v/v in 0.9% w/v sodium chloride for 10 minutes followed by an incubation period of 120 minutes. Negative and positive control items were tested concurrently. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS).
The test item is classified according to the prediction model as follows:
EU CLP(Regulation (EC) No 1272/2008)
Not classified for irritation
>3; ≤ 55
No prediction can be made
Category 1H318: Causes serious eye damage
The In Vitro irritancy scores are summarized as follows:
No prediction of eye irritation can be made.
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