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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

In vitro

Results
Irritation parameter:
other: ICE class
Value:
ca. 1
Remarks on result:
other:
Remarks:
ICE class is I for all values of the test item.
Other effects / acceptance of results:
In both experiments, no significant corneal swelling, corneal opacity change or fluorescein retention change was observed during the observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Based on the in vitro eye irritaion tests in isolated chicken eyes, the test item is not irritant to eye.