Registration Dossier
Registration Dossier
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EC number: 308-964-7 | CAS number: 99328-47-9
Eye irritation
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:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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. QA statement)
Test material
- Reference substance name:
- Aluminum oxide (Al2O3), chromium-doped
- EC Number:
- 308-964-7
- EC Name:
- Aluminum oxide (Al2O3), chromium-doped
- Cas Number:
- 99328-47-9
- Molecular formula:
- Al2O3, Cr
- IUPAC Name:
- Aluminum oxide (Al2O3), chromium-doped
Constituent 1
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.
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