Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 April 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
Principles of method if other than guideline:
There were no deviations from standard operating procedures that affected the integrity of the study.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(p-cumenyl)-2-methylpropionaldehyde
EC Number:
229-695-0
EC Name:
3-(p-cumenyl)-2-methylpropionaldehyde
Cas Number:
6658-48-6
Molecular formula:
C14H20O
IUPAC Name:
3-(4-isopropylphenyl)-2-methylpropanal
Specific details on test material used for the study:
Name (as stated in the report): Silvial
Batch No.: SC00017272
Expiration date: 23 October 2016

Test animals / tissue source

Species:
cattle
Details on test animals or tissues and environmental conditions:
Bovine eyes were used as soon as possible after slaughter. They come from young cattle were obtained from the slaughterhouse (Vitelco, 's Hertogenbosch, The Netherlands), where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter. Eyes were collected and transported in physiological saline in a suitable container under cooled conditions.

Test system

Vehicle:
unchanged (no vehicle)
Remarks:
The test item was tested neat.
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
Undiluted Silvial was introduced onto the epithelium of the cornea.
Duration of treatment / exposure:
The cornea were incubated in a horizontal position for 10 ± 1 minutes at 32 ± 1°C after the introduction of the test item or control.

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Remarks:
mean in vitro irritancy score
Run / experiment:
after 10 minutes of treatement
Value:
0.3
Negative controls validity:
valid
Remarks:
ranged from 0.7 to 1.1
Positive controls validity:
valid
Remarks:
ranged from 41 to 55
Remarks on result:
no indication of irritation
Remarks:
Since SILVIAL induced an IVIS ≤ 3,
Other effects / acceptance of results:
The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (Ethanol) was 46 and was within two standard deviations of the current historical positive control mean. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Since SILVIAL induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.
Executive summary:

Evaluation of the eye hazard potential of SILVIAL using the Bovine Corneal Opacity and Permeability test (BCOP test).

This report describes the potency of chemicals to induce serious eye damage using isolated bovine corneas. The eye damage of SILVIAL was tested through topical application for 10 minutes.

The study procedures described in this report were based on the most recent OECD guideline.

Batch SC00017272 of SILVIAL was a colourless liquid with a purity of 99.4%. The test item was applied as it is (750 μl) directly on top of the corneas.

The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (Ethanol) was 46 and was within two standard deviations of the current historical positive control mean. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

SILVIAL did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 0.3 after 10 minutes of treatment.

Since SILVIAL induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.