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EC number: 947-079-6
CAS number: -
Indvidual and mean corneal opacity measurements and individual and mean
corneal permeability measures are given in the table below.
Individual and Mean Corneal Opacity and Permeability Measurements
OD = Optical density
* = Mean of the post-incubation − pre-treatment values
~ = Mean permeability
# = Mean corrected value
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% w/v in 0.9% w/v
sodium chloride solution 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:
The In Vitro irritancy scores are summarized as follows:
No category. Not requiring classification to UN GHS or EU CLP.
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