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EC number: 218-566-4 | CAS number: 2184-11-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-11-24~2014-11-28
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tetrasodium 7,7'-[[6-(morpholin-4-yl)-1,3,5-triazine-2,4-diyl]diimino]bis[4-hydroxy-3-[(4-methoxy-2-sulphonatophenyl)azo]naphthalene-2-sulphonate]
- EC Number:
- 218-566-4
- EC Name:
- Tetrasodium 7,7'-[[6-(morpholin-4-yl)-1,3,5-triazine-2,4-diyl]diimino]bis[4-hydroxy-3-[(4-methoxy-2-sulphonatophenyl)azo]naphthalene-2-sulphonate]
- Cas Number:
- 2184-11-4
- Molecular formula:
- C41H36N10O17S4.4Na
- IUPAC Name:
- tetrasodium 7,7'-[[6-(morpholin-4-yl)-1,3,5-triazine-2,4-diyl]diimino]bis[4-hydroxy-3-[(4-methoxy-2-sulphonatophenyl)azo]naphthalene-2-sulphonate]
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report):Everdirect SH05(DR224)
- Substance type:Powder
- Composition of test material, percentage of components:68.89%
- Lot/batch No.:4501
- Expiration date of the lot/batch:2016-10-31
- Storage condition of test material:Refrigeration (5 ± 3℃)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- A dose of 0.1 g test article was applied to the conjunctival sac of the left eye of each rabbit. After application, the lid were gently held together for about 5~10 seconds. And right eye of each rabbits was served as blank control.
- Observation period (in vivo):
- 1, 24, 48, 72 hours after test article application
- Number of animals or in vitro replicates:
- Three female New Zealand white rabbits
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- Opacity, Area
- Basis:
- animal: 67
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: test group : left eye ; blank control group : right eye
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness, Chemosis, Discharge
- Basis:
- animal: 67
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: test group : left eye ; blank control group : right eye
- Irritation parameter:
- iris score
- Basis:
- animal: 67
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: test group : left eye ; blank control group : right eye
- Irritation parameter:
- cornea opacity score
- Remarks:
- Opacity, Area
- Basis:
- animal: 68
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: test group : left eye ; blank control group : right eye
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness, Chemosis, Discharge
- Basis:
- animal: 68
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: test group : left eye ; blank control group : right eye
- Irritation parameter:
- iris score
- Basis:
- animal: 68
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: test group : left eye ; blank control group : right eye
- Irritation parameter:
- cornea opacity score
- Remarks:
- Opacity, Area
- Basis:
- animal: 69
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: test group : left eye ; blank control group : right eye
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness, Chemosis, Discharge
- Basis:
- animal: 69
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: test group : left eye ; blank control group : right eye
- Irritation parameter:
- iris score
- Basis:
- animal: 69
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: test group : left eye ; blank control group : right eye
Any other information on results incl. tables
Table 1 : Body weight of the rabbits
Animal I.D. |
Sex |
Body weight (kg) |
|
Day 1 |
Day 4 |
||
67 |
Female |
2.0708 |
2.1146 |
68 |
Female |
2.0906 |
2.1350 |
69 |
Female |
2.1026 |
2.1906 |
Table 2 : Individual response of the test rabbits
Animal I.D. |
Time (hour) |
|
Grades of the irritation reaction |
|||||
Cornea |
Conjunctivae |
Iris |
||||||
Opacity |
Area |
Redness |
Chemosis |
Discharge |
||||
67 |
1 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
24 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
48 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
72 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
68 |
1 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
24 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
48 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
72 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
69 |
1 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
24 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
48 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
72 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The local irritation response of the rabbit eye were evaluated within 72 hours after the application. The result of this study indicated that all the three rabbit did not show any eye irritation response after application of the test article.
- Executive summary:
According to OECD Guideline 405 (Acute Eye Irritation / Corrosion), the test article was considered as non-irritant on the eye of the New Zealand white rabbits. The test results are "not irritating", so that hazard category in CLP is not classified.
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