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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
Study period:
2008
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The test consists of a topical exposure of the neat test item to a human reconstructed cornea model followed by a cell viability test. Cell viability is measured by dehydrogenase conversion of MTT [(3,.4,5-dimethylthiazole 2-yl) 2,5-diphenyl-tetrazoliumbromide], present in cell mithocondria, into a blue formazan salt that is quantitatively measured after extraction from tissues. The percent reduction of cell viability in comparison of untreated negative controls is used to predict eye irritation potential.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals / tissue source

Species:
other: tissues of human cornea model Epiocular

Test system

Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
3, 30 and 60min

Results and discussion

Any other information on results incl. tables

The in vitro study was performed to assess the eye irritation potential of GR-86 -2406 by means of the Human Cornea Model Test.

Tissues of the human cornea model EpiOcular were treated with the test item for 3, 30 and 60 minutes in duplicate. The cells for the negative control were treated for 60min and the positive control were treated for 60min and the positive control for 15 and 45min each in duplicate.

100microL of the liquid test item were applied to each tissue, spread to match the tissue size.

100microL of either the negative control (deionised water) or the positive control (0.3% Triton X-100) were applied to each tissue.

After treatment with the negative control the absorbance values were well above the required acceptability criterion of mean OD>=0.8 for the 60 min treatment interval thus showing the quality of the tissues.

Treatment with the positive control induced a sufficient decrease in the relative absorbance after both treatment intervals as compared to the negative control thus ensuring validity of the test system. No irritating effects were observed following incubation with GR-86 -2406 up to the longest treatment period (60 min). Due to the lack of cytotoxicity, a ET50 value could not be calculated.

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item GR-86 -2406 does not possess any eye irritating potential.

Applicant's summary and conclusion