Registration Dossier
Registration Dossier
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EC number: 953-553-3 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The test started on November 17. 2021 (9.30 a.m.), and ended on November 18, 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- OECD 492:2019
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
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 (incl. QA statement)
Test material
- Reference substance name:
- Fatty acids, palm-oil (C16-C18), Me esters, chlorinated (35-45 % w/w)
- EC Number:
- 953-553-3
- Cas Number:
- 95009-45-3
- Molecular formula:
- It cannot be provided.
- IUPAC Name:
- Fatty acids, palm-oil (C16-C18), Me esters, chlorinated (35-45 % w/w)
- Test material form:
- liquid
- Details on test material:
- Batch number: SV210723R 4001
Constituent 1
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- Reconstructed human corneal epithelium (RhCE) tissues
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- yes, concurrent positive control
- Amount / concentration applied:
- 50 mg
- Duration of treatment / exposure:
- 6 hours
- Duration of post- treatment incubation (in vitro):
- 18 hours
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vitro
Results
- Irritation parameter:
- percent tissue viability
- Run / experiment:
- two replicates
- Value:
- ca. 77.2
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Mean OD for the negative control tissues (C-) was 1.319. This value corresponds to 100% vitality of the tissues.
The vitality of positive control was 20.8%.
The vitality of treated samples was 77.2% with SD% of 0.2.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on above results, the test substance may be considered as: not irritant for the eyes.
The present test does not allow to discern between irritant category 1 or 2. - Executive summary:
The test substance was tested through a validated in vitro eye irritation study in accordance with bottom-up approach. Under the test conditions, the test substance was not irritant for Reconstructed human corneal epithelium (RhCE) as % tissue viability was about 77.2. Overall, the test substance is not considered as an eye irritant.
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