Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 237-354-2
CAS number: 13760-80-0
Table1: Individual and Mean Corneal Opacity and Permeability
In Vitro Irritancy Score
OD= Optical density
* = Mean of the post-treatment - pre-treatment values
** = Mean permeability
*** = Mean corrected value
The potential of the test material to cause eye irritation was
investigated under the standardised guidelines OECD 437 and EU method
B.47 under GLP conditions using the Bovine Corneal Opacity and
Permeability (BCOP) test method.
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 material is assessed by
quantitative measurements of changes in corneal opacity and permeability.
The test material was applied to the corneas at a concentration of 20 %
w/v in 0.9 % w/v sodium chloride solution for 240 minutes, the study was
performed in triplicate. Negative and positive control
materials were tested concurrently, in triplicate also. 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 in vitro irritancy score for the test material was 9.3 and as a
result it falls into the band of IVIS > 3 - ≤55 in the classification
system and so no prediction of eye irritation can be made.
The positive control In Vitro Irritancy Score was within the range of
66.9 to 101.4. The positive control acceptance
criterion was therefore satisfied. The negative control gave opacity of
≤ 4.1 and permeability ≤ 0.105. The
negative control acceptance criteria were therefore satisfied.
Under the conditions of this study, as the test material induced an IVIS
score of 9.3, no prediction on eye irritation can be made.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again