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EC number: 218-566-4 | CAS number: 2184-11-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-11-25~2014-11-28
- 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 404 (Acute Dermal 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
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Duration of treatment / exposure:
- Test article in a dose of 0.5 g were applied topically on backside skin of test animals for 4 hrs.
- Observation period:
- 1, 24, 48 and 72 hrs after patch removal
- Number of animals:
- Three female New Zealand white rabbits
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 70
- Time point:
- other: 1, 24, 48 and 72 hrs
- Score:
- 0
- Remarks on result:
- other: no erythema
- Irritation parameter:
- edema score
- Basis:
- animal: 70
- Time point:
- other: 1, 24, 48 and 72 hrs
- Score:
- 0
- Remarks on result:
- other: no edema
- Irritation parameter:
- erythema score
- Basis:
- animal: 71
- Time point:
- other: 1, 24, 48 and 72 hrs
- Score:
- 0
- Remarks on result:
- other: no erythema
- Irritation parameter:
- edema score
- Basis:
- animal: 71
- Time point:
- other: 1, 24, 48 and 72 hrs
- Score:
- 0
- Remarks on result:
- other: no edema
- Irritation parameter:
- erythema score
- Basis:
- animal: 72
- Time point:
- other: 1, 24, 48 and 72 hrs
- Score:
- 0
- Remarks on result:
- other: no erythema
- Irritation parameter:
- edema score
- Basis:
- animal: 72
- Time point:
- other: 1, 24, 48 and 72 hrs
- Score:
- 0
- Remarks on result:
- other: no edema
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: overall at 1, 24, 48 and 72 hrs
- Score:
- 0
- Remarks on result:
- other: non-irritant
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 |
||
70 |
Female |
2.0206 |
2.1040 |
71 |
Female |
2.0326 |
2.0998 |
72 |
Female |
2.0328 |
2.1106 |
Table 2 : Individual skin reaction
Animal I.D. |
Observation time (hours) |
Grading (erythema/edema) |
|||
Test area |
Control area |
||||
70 |
1 |
0/0 |
0/0 |
0/0 |
0/0 |
24 |
0/0 |
0/0 |
0/0 |
0/0 |
|
48 |
0/0 |
0/0 |
0/0 |
0/0 |
|
72 |
0/0 |
0/0 |
0/0 |
0/0 |
|
71 |
1 |
0/0 |
0/0 |
0/0 |
0/0 |
24 |
0/0 |
0/0 |
0/0 |
0/0 |
|
48 |
0/0 |
0/0 |
0/0 |
0/0 |
|
72 |
0/0 |
0/0 |
0/0 |
0/0 |
|
72 |
1 |
0/0 |
0/0 |
0/0 |
0/0 |
24 |
0/0 |
0/0 |
0/0 |
0/0 |
|
48 |
0/0 |
0/0 |
0/0 |
0/0 |
|
72 |
0/0 |
0/0 |
0/0 |
0/0 |
|
Table 3 : Individual animal primary irritation scores
Animal I.D. |
Scores |
Primary Irritation Scores (PIS) |
|
Test area |
Control area |
||
70 |
0 |
0 |
0 |
71 |
0 |
0 |
0 |
72 |
0 |
0 |
0 |
Primary Irritation index (PII) = 0 |
|||
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dorsal part of three New Zealand white rabbits after single dermal application with the test article for 4 hours were observed by experienced veterinarian, and found that there was no irritation response within 72 hours after patch removal. The primary irritation index (PII) of the test article was zero.
- Executive summary:
According to OECD Guideline 404 (Acute Dermal Irritation / Corrosion), the test article was considered as non-irritant on the skin of the New Zealand white rabbits. The test results are "non irritating", so that hazard category in CLP is not classified.
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