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EC number: 701-354-5
CAS number: -
Individual and Mean Corneal Opacity and Permeability
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
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
prediction of eye irritation can be made.
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