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:
april to june 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study by a laboratory having a GLP 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 treatment
Score:
0.9
Max. score:
1.2
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 4-hours treatment
Score:
6.6
Max. score:
10.7
Reversibility:
not specified

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 vitro scores of the 30-minute and 4-hour treatments, the test item EPOXY RESIN T1800 (batch No. 81016) tested in its original form is classified as slightly irritant for the isolated calf cornea.

Categories Display