Registration Dossier
Registration Dossier
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EC number: 943-065-9 | 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:
- 2015-11-20 to 2015-11-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Boron doped barium europium strontium silicate, orthorombic
- EC Number:
- 943-065-9
- Cas Number:
- 1800467-81-5
- Molecular formula:
- Sr2-x-y-zBaxEuyBzSiO4 (x=0.05-1.8; y=0.01-0.3; z=0.001-0.1; x+y<1.9)
- IUPAC Name:
- Boron doped barium europium strontium silicate, orthorombic
- Test material form:
- solid: particulate/powder
Constituent 1
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- 750 µL (i.e. 150mg/750µL) of test item, negative or positive control
- Duration of treatment / exposure:
- 240 minutes
- Number of animals or in vitro replicates:
- in vitro: triplicate design
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- run 1
- Value:
- 113.9
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- run 1
- Value:
- 62.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein leakage
- Run / experiment:
- run 1
- Value:
- 3.45
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
| Opacity |
Permeability |
IVIS |
||||
| per cornea |
per group (mean value) |
SD |
||||
| Negative Control |
0.9 % NaCl Solution |
-0.062 |
-0.001 |
-0.082 |
0.8 |
0.9 |
| 1.816 |
-0.001 | 1.801 |
||||
| 0.706 |
-0.001 | 0.696 |
||||
| Positive Control |
20 % Imidazole solution |
70.793 |
2.142 |
102.928 |
106.6 |
4.1 |
| 71.315 |
2.303 |
105.860 |
||||
| 79.270 |
2.119 |
111.060 |
||||
| Test material |
Art. 132039 |
66.507 |
3.447 |
118.217 |
113.9 |
16.4 |
| 72.337 |
3.699 |
127.827 |
||||
| 47.660 |
3.206 |
95.780 |
||||
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Under the given experimental conditions the test material the test material has ocular corrosive potential.
- Executive summary:
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 437. The test material was corrosive in this in vitro assay.
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