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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
human
Details on test animals or tissues and environmental conditions:
Tissues used in this study were Reconstructed human Cornea-like Epithelia (EpiOcularTM), of a surface of 0.60 cm².

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
50 mg
Duration of treatment / exposure:
6 hours
Duration of post- treatment incubation (in vitro):
18 hours and 01 minute post-exposure incubation
Number of animals or in vitro replicates:
2 living RhCE tissues replicates
Details on study design:
Evaluation of direct interaction of the test item with MTT as well as spectral analysis of the test item in isopropanol were performed prior to the study.

Results and discussion

In vitro

Results
Irritation parameter:
other: tissue viability (%)
Run / experiment:
mean
Value:
ca. 104.57
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
Validity criteria were fulfilled.
There was no direct interaction between the test item and MTT and the test item did not interfere with the MTT assay.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions adopted and in accordance with the Regulation EC No. 1272/2008, the test item Gamma Chrome does not require classification for eye irritation or serious eye damage. It corresponds to the UN GHS No Category.
No hazard statement and the signal word are required.