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EC number: 701-281-9 | CAS number: -
Table1: Opacity, 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 control substances:
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" was -0.6.
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).
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