Registration Dossier
Registration Dossier
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EC number: - | 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:
- 2 020
- Report date:
- 2020
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:
- L-Tyrosine, N-acetyl-3,5-dinitro-, etyhl ester
- Cas Number:
- 29358-99-4
- Molecular formula:
- C13H15N3O8
- IUPAC Name:
- L-Tyrosine, N-acetyl-3,5-dinitro-, etyhl ester
Constituent 1
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- percent tissue viability
- Run / experiment:
- 2
- Value:
- ca. 48
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- percent tissue viability
- Run / experiment:
- 1
- Value:
- ca. 45.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- One valid experiment was performed.
The solid test item L-Tyrosine, N-acetyl-3,5-dinitro-, ethyl ester was applied to a three-dimensional human cornea tissue model in duplicate for an exposure time of 6 hours.
After treatment, the respective substance was rinsed from the tissue; then, cell viability of the tissues was evaluated by addition of MTT, which can be reduced to formazan. The formazan production was evaluated by measuring the optical density (OD) of the resulting solution.
Demineralised water was used as negative control and methyl acetate was used as positive control.
The controls showed the following results: After treatment with the negative control, the absorbance values were within the required acceptability criterion of mean OD > 0.8 and < 2.8, OD was 1.6. The positive control showed clear eye irritating effects, the mean value of the relative tissue viability was 33.2% (< 50%).
The variation within tissue replicates of the controls and the test item was acceptable (< 20%).
After treatment with the test item, the mean value of relative tissue viability was 46.6%.
This value is below the threshold for eye irritation potential (≤ 60%). Test items that induce values below the threshold are considered either eye irritant or inducing serious eye dam-age.
According to the OECD Guideline 492, the EpiOcularTM Eye Irritation Test does not allow discrimination between eye irritation/reversible effects on the eye (Category 2) and serious eye damage/irreversible effects on the eye (Category 1). For these purposes, further test-ing with other suitable test methods is required.
Under the conditions of the test, L-Tyrosine, N-acetyl-3,5-dinitro-, ethyl ester is con-sidered either eye irritant or inducing serious eye damage in the EpiOcularTM Eye Irritation Test. - Executive summary:
As OECD 437 test leads to no classification, the overall classification is "Eye irritant 2, H319"
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