Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
Qualifier:
according to
Guideline:
EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
30 mg/ eye
Duration of treatment / exposure:
10 s
Observation period (in vivo):
240 min

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Corneal opacity score
Basis:
mean
Time point:
other: 240 min
Score:
2
Remarks on result:
other: Value: 1.3
Irritation parameter:
other: Corneal swelling
Basis:
mean
Time point:
other: 75 min
Score:
3
Remarks on result:
other: Value: 24 %
Irritation parameter:
other: Corneal swelling
Basis:
mean
Time point:
other: 240 min
Score:
3
Remarks on result:
other: Value: 27 %
Irritation parameter:
other: Fluorescein retention
Basis:
mean
Time point:
other: 30 min
Score:
2
Remarks on result:
other: Value: 0.8

Applicant's summary and conclusion

Interpretation of results:
other: No prediction can be made
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
According to the guideline OECD 438, test item has been categorized as “No prediction can be made”.
Executive summary:

The purpose of this Isolated Chicken Eye Test (ICET) was to evaluate the potential ocular corrosivity and irritancy of the test item Morin by its ability to induce toxicity in enucleated chicken eyes. The test compound was applied in a single dose (30 mg/eye) onto the cornea of isolated chicken eyes in order to potentially classify the test compound as either 1: causing "serious eye damage" (category 1 of the Globally Harmonised System for the Classification and Labelling of chemicals (GHS)), or 2: not requiring classification for eye irritation or serious eye damage according to the GHS. Tested corneas were evaluated pre-treatment and at approximately 30, 75, 120, 180 and 240 minutes after the post-treatment rinse. The endpoints evaluated were corneal opacity, swelling, fluorescein retention, and morphological effects. All of the endpoints, with the exception of fluorescein retention (which was determined only at pre-treatment and 30 minutes after test substance exposure) were determined at each of the above time points.

The Morin and Imidazole (positive control) were ground before use in the study. They were applied in an amount of 0.03 g/eye by powdering the entire surface of the cornea attempting to cover the cornea surface uniformly with the test substance or positive control. Three test item treated eyes and three positive control eyes were used in this study.

One negative control eye was treated with 30 μL saline solution.

After an exposure period of 10 seconds from the end of the application the cornea surface was rinsed thoroughly with ~20 mL saline solution at ambient temperature and this procedure was repeated for each eye.

In this ICET, Morin did not cause ocular corrosion or severe irritation in the enucleated chicken eyes. The overall ICE class was 2×II, 1xIII. Positive and negative controls showed the expected results.

According to the guideline OECD 438, Morin overall in vitro classification is neither UN GHS Classification Category I (an ocular corrosive or severe eye irritant) nor No Category. Thus, according to the guideline OECD 438, test item has been categorized as “No prediction can be made”.