Registration Dossier
Registration Dossier
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EC number: 615-738-4 | CAS number: 72245-35-3
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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
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:
- Hydrolysis product of chloro(dimethyl)octadecylsilane and silica gel
- EC Number:
- 615-738-4
- Cas Number:
- 72245-35-3
- Molecular formula:
- SiC20H43
- IUPAC Name:
- Hydrolysis product of chloro(dimethyl)octadecylsilane and silica gel
1
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- Reconstructed human Cornea-like Epithelium
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 at 37 ± 1°C, 5 ± 1 % CO2
- Number of animals or in vitro replicates:
- 2
Results and discussion
In vitro
Results
- Irritation parameter:
- percent tissue viability
- Value:
- 116.89
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD 492:2019, under the test conditions applied, the test substance is considered as not requiring classification and labeling according to UN GHS (No category).
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