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)
Rationale for reliability incl. deficiencies:
other: Completed by a CGLP laboratory to an approved methodology.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other:
Principles of method if other than guideline:
The SkinEthic HCE model consists of transformed human keratinocytes of the cell line HCE (LSU EYE Center) that form a corneal epithileal tissue (mucosa), devoid of stratum corneum, resembling, histologically, the mucosa of the human eye. The test material is applied directly to the culture surface, at the air interface, so that undiluted and/or end use dilution can be tested directly. The test is based on the hypothesis that irritant chemicals are able to penetrate the stratum corneum of the SkinEthic HCE model and are sufficiently cytotoxic to cause cel death in the underlying cell layers.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

In vivo

Results
Irritation parameter:
other: Tissue viability
Basis:
mean
Remarks:
Relative mean tissue viability
Time point:
other: 10mins
Score:
ca. 106
Max. score:
100
Reversibility:
not specified
Remarks on result:
other: in vitro study showing no signs of irritation

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment