Registration Dossier
Registration Dossier
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EC number: 211-322-8 | CAS number: 638-16-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08.10.2019 to 18.11.2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
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:
- 1,3,5-triazine-2,4,6(1H,3H,5H)-trithione
- EC Number:
- 211-322-8
- EC Name:
- 1,3,5-triazine-2,4,6(1H,3H,5H)-trithione
- Cas Number:
- 638-16-4
- Molecular formula:
- C3H3N3S3
- IUPAC Name:
- 1,3,5-triazine-2,4,6(1H,3H,5H)-trithione
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- This test uses the three-dimensional RhCE EpiOcular™ (MatTek). It consists of normal, human-derived epidermal keratinocytes and mimics the histological, morphological, biochemical and physiological properties of the human corneal epithelium. The MatTek EpiOcular™ model has been widely used as a research and testing model for many years.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 50 mg of test item
- Duration of treatment / exposure:
- 6 h
- Duration of post- treatment incubation (in vitro):
- 18 h
- Number of animals or in vitro replicates:
- 2
Results and discussion
In vitro
Results
- Irritation parameter:
- other: mean relative tissue viability [%]
- Run / experiment:
- 1
- Value:
- 72.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item showed no irritant effects. The test item showed no irritant effects. The mean relative tissue viability (% negative control) was > 60% (72.8%). The test item is classified as “non-irritant“ in accordance with UN GHS “No Category”.
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