Registration Dossier

Toxicological information

Eye irritation

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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: GLP Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other:
Principles of method if other than guideline:
Reconstitured Human Cornea: Determination of eye irritation potential using the SkinEthic Reconstituted Human Corneal model (RHC, SkinEthic Labs, Nice, France) following treatment periods of 10 and 60 minutes. The test is based on the hypothesis that irritant materials are able to penetrate the corneal epitelial tissue and are sufficiently cytotoxic to cuase cell death.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
human

Test system

Vehicle:
unchanged (no vehicle)

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
other: relative mean viability
Run / experiment:
10 mins
Value:
ca. 36.8
Negative controls validity:
valid
Remarks on result:
positive indication of irritation
Irritation parameter:
other: relative mean viability
Run / experiment:
60 mins
Value:
ca. 4.4
Negative controls validity:
valid
Remarks on result:
positive indication of irritation
Other effects / acceptance of results:
RHC Model: The relative mean viability of the test material treated tissue was 36.8% after 10minutes and 4.4% after 60 minute exposure.

Any other information on results incl. tables

results are from in vitro/ ex vivo studies and time points, score and max score are not applicable endpoints

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
GSK1873183A was considered to be irritating to eyes based upon the results of the in vitro/ex vivo studies.
Executive summary:

An in vitro test strategy was adopted to assess the potential eye irritation of GSK1873183A. In the rabbit enulceated eye test (REET), 0.1ml of test material was applied to the cornea of each of three enucleated eyes which had been maintained ata temperature of 32deg C within the superfusion chamber. A further two enucleated eyes were treated with saline solution as controls. Assessment or corneal cloudiness was made approx 60, 120, 180 and 240mins following treatment. Examination of the eye facilitated by use of a slit-lamp biomicroscope and the thickness of the cornea was measured using an ultrasonic pachymeter. In the Human Reconsititued Corneal Model (RHC) determination of eye irritation potential was assessed using the SkinEthic Reconstituted Human Corneal model (RHC, SkinEthic Labs, Nice, France) following treatment periods of 10 and 60 minutes. The test is based on the hypothesis that irritant materials are able to penetrate the corneal epitelial tissue and are sufficiently cytotoxic to cuase cell death.

The REET assay indicated that GSK1873183A is unlikely to have potential to cause severe ocular irritancy in vivo. The RHC model indicated thatthe test material is likley to be a moderate eye irritant and should be classified as R36; Irritating to eyes (GHS Category 2A)