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EC number: 947-946-9
CAS number: -
In Vitro Irritancy Score
0.9% (w/v) Sodium Chloride (Negative Control)
Neat Ethanol (Positive Control)
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.
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.
undiluted test item was applied for 10 minutes followed by an incubation
period of 120 minutes. Negative
(0.9% (w/v) Sodium Chloride) and positive (Neat Ethanol) 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).
on the results of the BCOP test, no prediction of eye irritation can be
made for the test item.
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