Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 13-15, 2014
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Physical state: solid
- Colour: colourless
- Storage condition of test material: dry, at room temperature

Test system

Amount / concentration applied:
Enough test substance to cover the whole cornea was applied directly onto the cornea by removing the window-locking ring and glass window prior to treatment and moistened with physiological saline 0.9%.
Details on study design:
TEST GROUPS:
- 3 corneas for the test item
- 3 corneas as negative controls treated with physiological saline 0.9% NaCl
- 3 corneas as positive control treated with imidazole 20% in physiological saline 0.9% NaCl


SCORING SYSTEM (Evaluation of the BCOP Assay):

The IVIS cut-off values for identifying test substances as inducing serious eye damage (UN GHS Category 1) and test substances not requiring classification for eye irritation or serious eye damage (UN GHS No Category) are as fllows:

- Mean score ≤ 3: no category
- Mean score >3; ≤ 55: no prediction can be made
- Mean score >55: Category 1

An identification of test substances that should be classified as irritating to eyes (UN GHS Category 2 or Category 2A) or test substances that should be classified as mildly irritating to eyes (UN GHS Category 2B) cannot be made.

Results and discussion

In vivo

Results
Irritation parameter:
other: bovine corneal opacity and permeability
Time point:
other: not applicable
Score:
313.15
Reversibility:
other: not applicable
Remarks on result:
other: in-vitro test
Irritant / corrosive response data:
The eye irritancy potential of the test item was investigated in the bovine corneal opacity and permeability assay. The test item was tested as provided by the sponsor. The following mean in vitro irritation score was calculated: 313.15.

Therefore the test item was classified into UN GHS Category 1.

The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information
Conclusions:
According to the evaluation criteria the test item is classified into UN GHS Category 1.