Registration Dossier
Registration Dossier
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EC number: 238-475-3 | CAS number: 14481-26-6
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:
- 2 019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Qualifier:
- according to guideline
- Guideline:
- EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Dipotassium titanium oxide dioxalate
- EC Number:
- 238-475-3
- EC Name:
- Dipotassium titanium oxide dioxalate
- Cas Number:
- 14481-26-6
- Molecular formula:
- C4K2O9Ti
- IUPAC Name:
- dipotassium oxotitaniumbis(ylium) dioxalate
Constituent 1
Test animals / tissue source
- Species:
- chicken
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 30 mg
- Duration of treatment / exposure:
- 10 seconds
- Number of animals or in vitro replicates:
- 3 enucleated chicken eyes
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- mean
- Value:
- 0
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- mean
- Value:
- 2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- mean
- Value:
- 11
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The combination of the three endpoints (mean score of corneal opacity, mean score of fluorescein retention, mean corneal swelling) for the test item Oxalate de Titanyl Potassium was 1xIII, 1xII, 1xI.
In accordance with the Regulation 1272/2008, the results obtained under these experimental conditions lead to the category "No prediction can be made", as defined by the OECD guideline 438.
Therefore, the test item Oxalate de Titanyl Potassium is not predicted as causing serious eye damage (Category 1) or as not classified for eye irritation/serious eye damage (No category) with the Isolated Chicken Eye test method. Additional testing (in vitro and/or in vivo) are required to established a definitive classification.
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