Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April to june 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study by a laboratory having a GPL certificate

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other:
Deviations:
no
Principles of method if other than guideline:
The principle is based on the measurement of two factors; the opacity and the permeability of the treated corneas. The changes in these parameters correspond to the dammages induced to the tissues. The method used is adapted from that described by Gautheron P. & al. (1992) Fundam. APPL. Toxicol. 18 442-449
GLP compliance:
yes (incl. QA statement)
Remarks:
Certificate on january 27th 2009

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 30-minutes treatement
Score:
0.3
Max. score:
2.3
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 4-hour treatment
Score:
8.3
Max. score:
13
Reversibility:
not specified

Any other information on results incl. tables

For each experiment, the acceptance criteria were fulfilled and the study was therefore considered to be valid.

No notable opaque spots or irregularities were observed on negative control corneas, either following the-minutes treatment or following the 4 -hour treatment.

Fluoresceine fixation was observed on test item-treated corneas, following both the 30 -minute and 4 -hour treatments

Following the 30 -minute treatement, the mean in vitro score was 0.3. Then following the 4 -hour treatment, the mean in vitro score was 8.3.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions of this study, according to both mean in vitroscores of the 30-minute and 4-hour treatments, the test item, Urethan Resin M2001 (batch N° 081128K), tested in its original form, is classified as slightly irritant for the isolated calf cornea.