Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 437
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
other: fresh bovine corneae

Test system

Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
90min

Results and discussion

Any other information on results incl. tables

This in vitro study was performed to assess the corneal irritation and damage potential of GR-50-0091 by means of the BCOP assay using fresh bovine corneae. After a first opacity measurement of the fresh bovine corneae (t0), the neat test item GR-50-0091, the positive, and the negative controls were applied to corneae and incubated for 10 minutes at 32 ± 1 °C. The posterior chamber contained MEM medium supplemented with sodium bicarbonate and L-glutamine and 1% fetal calf serum (FCS) (complete medium = cMEM). After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneae. Further, the corneae were incubated for another 120 minutes at 32 ± 1 °C in complete medium, and opacity was measured a second time (t130). After the opacity measurements permeability of the corneae was determined by measuring spectrophotometrically the transfer of fluorescein after incubation in a horizontal position for 90 minutes at 32 ± 1 °C. W ith the negative control (0.9% (w/v) NaCl solution in deionised water) neither an increase of opacity nor permeability of the corneae could be observed. The positive control (2-Ethoxyethanol) showed clear opacity and distinctive permeability of the corneae (mean in vitro score 56.2) corresponding to a classification as corrosive to the eye (CLP/EPA/GHS (cat. 1; H318)). Relative to the negative control, the test item GR-50-0091 caused an increase of the corneal opacity and permeability. The calculated mean in vitro score was 22.00. According to the INVITTOX (UK) protocol no. 98 the test item is classified as mild eye irritant. In conclusion, according to the current study and under the experimental conditions reported, the test item GR-50-0091 is not corrosive to the eye (EU CLP/GHS (cat. 1; H318)). Corresponding to the INVITTOX (UK) protocol no. 98 classification GR-50-0091 is mild eye irritant.

Applicant's summary and conclusion

Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Remarks:
Migrated information