Registration Dossier
Registration Dossier
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EC number: 243-494-5 | CAS number: 20062-22-0
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:
- 2020
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)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2',4,4',6,6'-hexanitrostilbene
- EC Number:
- 243-494-5
- EC Name:
- 2,2',4,4',6,6'-hexanitrostilbene
- Cas Number:
- 20062-22-0
- Molecular formula:
- C14H6N6O12
- IUPAC Name:
- 1,3,5-trinitro-2-[(E)-2-(2,4,6-trinitrophenyl)ethenyl]benzene
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- Batch no. 18909-1
Composition 100 %
Expiry date 27/2/2028
Test animals / tissue source
- Details on test animals or tissues and environmental conditions:
- 3 reconstructed human cornea-like epithelium
Test system
- Controls:
- yes
- Duration of treatment / exposure:
- 6 hours exposure time
- Number of animals or in vitro replicates:
- one experiment.
Results and discussion
In vitro
Results
- Irritation parameter:
- percent tissue viability
- Value:
- 98
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- After treatment with the test item, the mean value of relative tissue viability was reduced to
98.0 %. This value is above the threshold for eye irritation potential (≤ 60%).
All validity criteria were met. The criterion for optical density of the negative control was
fulfilled: The OD value was 1.7 (> 0.8 and < 2.8).
The positive control induced a decrease in tissue viability as compared to the negative
control to 33.3%.
Variation within the replicates of the controls and the test item was acceptable (< 20%).
For these reasons, the result of the test is considered valid.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the test, HEXANITROSTILBENE is considered non- eye irritant in the EpiOcularTM Eye Irritation Test.
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