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EC number: 701-281-9
CAS number: -
permeability and IVIS values
Opacity, permeability (1 x value measured and 15 x values for IVIS
calculation) and IVIS values of test substance, negative and positive
controls. Individual data, means
and standard deviations (SD).
1 % Sodium hydroxide(PC)
The temperature of the incubator was 29.3 °C – 33.7 °C instead of
31 °C – 33 °C. This deviation is considered to be of no relevance for
the outcome of this study.
The Bovine Corneal Opacity and Permeability Study (BCOP Test
Method) was performed to reveal possible ocular corrosivity and severe
irritation of "3-Hydroxy-2-(hydroxymethyl)-2-methylpropionaldehyde",
according tothe OECD Guideline 437 for the testing of chemicals “Bovine
Corneal Opacity and Permeability Test Method for Identifying Ocular
Corrosives and Severe Irritants”,.
Fresh isolated and quality checked corneas were mounted in cornea
holders and the initial opacity was determined. After equilibration 750
µl of the test substance (as is) were topicallyadministered to 3
isolated bovine corneas to the epithelial surfaces for 10 minutes. After
a post-incubation period of 2 hours, the final opacity was measured.
Then 1 ml of a fluorescein solution was added on the epithelial site and
permeability was measured after 90 minutes.
Two groups of 3 corneas each served as positive and negative
controls. Both control substances were administered under identical
conditions as the test substance. The following solutions served as
Finally the IVIS (In Vitro Irritancy
Score) was calculated as follows:
IVIS = mean opacity value + (15 x mean permeability).
The opacity and mean permeability values were corrected for
background opacity and the negative control permeability values. The
mean opacity value results from subtraction of final opacity from
initial opacity. A substance that induces an IVIS≥55.1 is defined as
ocular corrosive or severe irritant.
The IVIS for "3-Hydroxy-2-(hydroxymethyl)-2-methylpropionaldehyde"
IVIS of the negative control was -1.0 and for the positive control
123.5, thus demonstrating the validity of the experiment.
According to the results of this study and the OECD Guideline 437,
the test substance
"3-Hydroxy-2-(hydroxymethyl)-2-methylpropionaldehyde" is considered to
be not an ocular corrosive or severe irritant.
According to the guidelines
"3-Hydroxy-2-(hydroxymethyl)-2-methylpropionaldehyde" needs not to be
labelled as R41 (EU), Category 1 (EPA and GHS).
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.
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