Registration Dossier
Registration Dossier
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EC number: 949-344-1 | 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:
- 29.11. - 13.12.2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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)
- Version / remarks:
- 25 Jun 2018
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of L-alanyl-L-tyrosine hydrochloride and potassium chloride
- EC Number:
- 949-344-1
- Molecular formula:
- C12H16N2O4.ClH and KCl
- IUPAC Name:
- Reaction mass of L-alanyl-L-tyrosine hydrochloride and potassium chloride
Constituent 1
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- approx. 50 mg (83.3 mg/cm²)
- Duration of treatment / exposure:
- 6 ± 0.25 h
- Duration of post- treatment incubation (in vitro):
- 18 ± 0.25 h and 3 h ± 15 min
Results and discussion
In vitro
Results
- Irritation parameter:
- other: relative tissue viability
- Run / experiment:
- Experiment 1
- Value:
- 3.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In this study under the given conditions the test item showed irritant effects. The test item is therefore classified as “eye irritant” in accordance with UN GHS “Category 2”. However, as no follow-up studies regarding the endpoint "eye corrosion" were performed, the test item is concluded as " eye corrosive" in accordance with UN GHS “Category 1”.
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