Registration Dossier
Registration Dossier
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EC number: 425-880-7 | 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:
- Sep 11, 2018 - Jun 27, 2018
- 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:
- 2018
Materials and methods
Test guidelineopen allclose all
- 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)
- Version / remarks:
- October 9, 2017
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: DB-ALM Protocol No. 164: Ocular Irritation Assay for Chemicals using EpiOcular™ EIT,
- Version / remarks:
- September 14, 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EpiOcular Eye Irritation Test (OCL-200-EIT) for the prediction of acute ocular irritation of chemicals; For use with MatTek Corporation`s Reconstructed Human EpiOcular Model; MatTek Corporation
- Version / remarks:
- June 29, 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 425-880-7
- EC Name:
- -
- Cas Number:
- 182311-45-1
- Molecular formula:
- C31H40O5
- IUPAC Name:
- 4-[(1s,4r)-4-propylcyclohexyl]phenyl 4-{[6-(prop-2-enoyloxy)hexyl]oxy}benzoate
- Test material form:
- solid: bulk
Constituent 1
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL: 50 µL per tissue
NEGATIVE / VEHICLE CONTROL: 50 µL per tissue
Sterile deionized water was used as negative control.
POSITIVE CONTROL: 50 µL per tissue
Designation: Art. 8.09711
Synonym: Methyl acetate
Supplier: Merck KGaA
CAS No.: 79-20-9
Batch No.: S7451611
Appearance: Liquid
Content (GC): 99.6 % (a/a)
Expiry Date: June 30, 2022
Storage conditions: Tightly closed, dark, at room temperature (15 – 25°C) - Duration of treatment / exposure:
- 30 ± 2 minutes
- Number of animals or in vitro replicates:
- in vitro: duplicate design
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Viability %
- Run / experiment:
- Run 1 / Experiment 1
- Value:
- 100.6
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No observations
ACCEPTANCE OF RESULTS:
The results are acceptable if:
1. The negative control OD >0.8 and <2.5
2. The mean relative viability of the positive control is:
a) 30 minute exposure: below 50% of control viability
b) 6 hour exposure: below 50% of control viability
3. The difference of viability between the two relating tissues of a single chemical is <20% in the same run (for positive and negative control tissues and tissues of single chemicals). This applies also to the killed controls (single chemicals and negative killed control) and the colorant controls which are calculated as percent values related to the viability of the relating negative control.
Any other information on results incl. tables
| Mean OD | Mean Viability | |
| Negative Control | 1.804 | 100.0% |
| Positive Control | 0.482 | 26.7% |
| Test Item | 1.814 | 100.6% |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, the test item did not show an eye hazard potential. The test item is identified as not requiring classification and labeling according to UN GHS (No Category).
- Executive summary:
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 492.
Under the conditions of the present study, the test item did not show an eye hazard potential. The test item is identified as not requiring classification and labeling according to UN GHS (No Category).
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