Registration Dossier
Registration Dossier
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EC number: 942-177-5 | 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)
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)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Plastic, waste, pyrolized, distn., oil
- Molecular formula:
- Not applicable
- IUPAC Name:
- Plastic, waste, pyrolized, distn., oil
- Test material form:
- liquid
- Details on test material:
- Substance manufactured by the lead registrant according to the third compostion included in the registration dossier of Plastic, waste, pyrolized, fractionation bottoms (Raw Diesel)
Constituent 1
Test animals / tissue source
- Species:
- human
- Strain:
- other: Reconstructed human Cornea-like Epithelium (RhCE)
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
Results and discussion
In vitro
Results
- Irritation parameter:
- other: % viability
- Run / experiment:
- 1
- Value:
- ca. 96.9
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- After treatment with the test item, the mean value of relative tissue viability was reduced to 96.9 %. This value is above the threshold for eye irritation potential (≤ 60%).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the test, TACOIL is considered non-eye irritant in the EpiOcularTM Eye Irritation Test.
After treatment with the test item, the mean value of relative tissue viability was reduced to 96.9 %. This value is above the threshold for eye irritation potential (≤ 60%).
All validity criteria were met. The criterion for optical density of the negative control was fulfilled: The OD value was 2.0 (> 0.8 and < 2.8).
The positive control induced a decrease in tissue viability as compared to the negative control to 31.5%.
The variation within the replicates of the controls and the test item was acceptable (< 20%).
For these reasons, the result of the test is considered valid.
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