Registration Dossier
Registration Dossier
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EC number: 814-615-4 | CAS number: 122958-50-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2015
Materials and methods
Test guideline
- 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)
- GLP compliance:
- yes
Test material
- Reference substance name:
- (5R)-5-[(1S)-1,2-dihydroxyethyl]-3,4-dihydroxy-2,5-dihydrofuran-2-one titanium
- EC Number:
- 814-615-4
- Cas Number:
- 122958-50-3
- Molecular formula:
- TiO(Asc)2 x2 H2O
- IUPAC Name:
- (5R)-5-[(1S)-1,2-dihydroxyethyl]-3,4-dihydroxy-2,5-dihydrofuran-2-one titanium
Constituent 1
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- Mean maximum corneal opacity
- Value:
- 0.5
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- corneal swelling
- Remarks:
- Mean maximum corneal swelling at up to 75 min
- Value:
- 3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Mean maximum corneal swelling at up to 240 min
- Value:
- 4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- In this ICET, TITANIUM DIASCORBATE did not cause ocular corrosion or severe irritation in the enucleated chicken eyes in both cases. The overall ICE class was 2xI, 1xII in the first and 1xI, 2xII in the additional experiment.
Positive and negative controls showed the expected results. The experiment was considered to be valid.
In this in vitro eye irritation study, using the Isolated Chicken Eye model with TITANIUM DIASCORBATE, no ocular corrosion or severe irritation potential was observed. The overall ICE class was 2xI, 1xII in the first and 1xI, 2xII in the additional experiment.
According to the guideline OECD 438, TITANIUM DIASCORBATE is categorized as “No Category”.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this in vitro eye irritation study, using the Isolated Chicken Eye model with TITANIUM DIASCORBATE, no ocular corrosion or severe irritation potential was observed. The overall ICE class was 2xI, 1xII in the first and 1xI, 2xII in the additional experiment.
According to the guideline OECD 438, TITANIUM DIASCORBATE is categorized as “No Category”.
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