Registration Dossier
Registration Dossier
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EC number: 904-790-6 | CAS number: -
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:
- 2 022
- Report date:
- 2023
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:
- Reaction mass of (24R)-ergost-5-en-3β-ol and stigmast-5-en-3-β-ol and stigmasta-5,22-dien-3-β-ol
- EC Number:
- 904-790-6
- Molecular formula:
- C28H48O; C29H50O; C29H48O
- IUPAC Name:
- Reaction mass of (24R)-ergost-5-en-3β-ol and stigmast-5-en-3-β-ol and stigmasta-5,22-dien-3-β-ol
Constituent 1
- Specific details on test material used for the study:
- Identity MIXTURE OF PHYTOSTEROLS
Alternative name Mixture of beta-sitosterol, stigmasterol, campesterol, brassicasterol
Batch number YH18ZC040304
Expiry date October 2023
Storage conditions Room temperature
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- In the Main Assay, the test item was applied in two replicates at the treatment level of 30 ± 2 mg/tissue unit.
- Duration of treatment / exposure:
- 4 hours followed by a 30 minutes post-soak period
- Duration of post- treatment incubation (in vitro):
- 18 hours
- Number of animals or in vitro replicates:
- two replicates
Results and discussion
In vitro
Results
- Irritation parameter:
- mean percent tissue viability
- Run / experiment:
- Main Assay I
- Value:
- 97
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results obtained, the test item MIXTURE OF PHYTOSTEROLS is considered
as non-irritant to the eye (UN GHS No Category).
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