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Registration Dossier
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EC number: 942-795-5 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 to 4.5 hour exposure
- 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 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-[(4-chloro-6-{[(3 or 4)-sulfophenyl]amino}-1,3,5-triazin-2-yl)amino]-2-{[1-ethyl-2-hydroxy-4-methyl-6-oxo-5-(sulfonatomethyl)-1,6-dihydropyridin-3-yl]diazenyl}benzenesulfonic acid, lithium sodium salts
- EC Number:
- 942-795-5
- Molecular formula:
- Not applicable; this UVCB substance contains: C24H20ClN8O11S3.xLi.yNa, (x + y) = 3; 0 < (x,y) < 3 with 748.9 < MW < 797.0 g/mol (UVCB substance), C24H21N8O12S3.xLi.yNa, (x + y) = 3; 0 < (x,y) < 3 with 730.4 < MW < 778.6 g/mol (UVCB substance), C18H15Cl2N7O8S2.xLi.yNa, (x + y) = 2; 0 < (x,y) < 2 with 606.2 < MW < 638.3 g/mol (UVCB substance), C21H17N8O9S3.xLi.yNa, (x + y) = 3; 0 < (x,y) < 3 with 642.4 < MW < 690.5 g/mol (UVCB substance), C30H25N9O14S4.xLi.yNa, (x + y) = 4; 0 < (x,y) < 4 with 891.5 < MW < 955.7 g/mol (UVCB substnace), and traces of NaCl and Na2SO4.
- IUPAC Name:
- 4-[(4-chloro-6-{[(3 or 4)-sulfophenyl]amino}-1,3,5-triazin-2-yl)amino]-2-{[1-ethyl-2-hydroxy-4-methyl-6-oxo-5-(sulfonatomethyl)-1,6-dihydropyridin-3-yl]diazenyl}benzenesulfonic acid, lithium sodium salts
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Source: Kitayama Labes Co., Ltd. (Japan)
- Age at study initiation: approximately 11 to 12 months
- Weight at study initiation: 3595 to 4685 g
- Housing: individually in a stainless steel wire mesh cage
- Water: ad libitum
- Acclimation period: at least 5 days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 50 ± 20%
- Photoperiod: 12hrs dark / 12hrs light
Test system
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- Water for injection (WFI, Taiwan Biotech Co., Ltd., Lot: 4KO1838)
- Controls:
- yes
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit): 0.5 g test article was moistened with 0.3 mL water for injection
- Duration of treatment / exposure:
- 4-4.5 hours
- Observation period:
- 1, 24, 48 and 72 hour
- Number of animals:
- three
- Details on study design:
- - Area of exposure: left dorsal area
- Washing (if done): with lukewarm water
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: mean of all observation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Remarks on result:
- other: mean of all observation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: mean of all observation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: mean of all observation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: mean of all observation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: mean of all observation
Any other information on results incl. tables
Table 1. Individual Body Weights and Clinical Observations
Animal ID |
Body weight (g) |
Body weight change (g) |
Clinical observation |
|
D1 |
D4 |
D4-D1 |
||
1 |
3595 |
3561 |
-34 |
Normal |
2 |
4384 |
4396 |
12 |
Normal |
3 |
4685 |
4748 |
63 |
Normal |
Table 2. Individual Scores and Total Scores for Skin Irritation During 72 hours
Animal ID |
1 |
2 |
3 |
|||||||||
Score on each observation point (hour) |
||||||||||||
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
|
Control site |
||||||||||||
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Total irritation score for vehicle* |
0 |
0 |
0 |
|||||||||
Test site |
||||||||||||
Erythema |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Total irritation score for vehicle* |
0 |
1 |
0 |
|||||||||
PII** |
0.11 |
|||||||||||
* The sum of scores at 24, 48 and 72 hours.
** (Total irritation score for test article-Total irritation score for vehicle)/9
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD 404 test method and Draize Dermal Classification System, the PII for CJ301 in intact skin was 0.11 and CJ301 was categorized as mild irritant based on GHS criteria. However, according to ECHA guidance on the application of the CLP Criteria 3.2.2.3.2.2 in vivo data, for up to 3 rabbits test the Skin Irritant Category 2 is used if at least 2 animals show a mean score of 2.3 or above. Therefore, CJ301 is not classified as irritant based on CLP criteria.
- Executive summary:
This test using the procedures outlined in the QPS Taiwan Study Plan for T65315013-IR which is based on the SOP for the OECD 404 (CTPS-TE00440) and OECD 404 (OECD, 2015). The sites were grades for erythema and edema at 1, 24, 48 and 72 hours after the patches removal. No clinical signs of toxicity were found. Body weight changes were within the normal range in all animals. Erythema with score 1 was observed in one animal during 24 hours after patch removal. The Primary Irritation Index for CJ301 was calculated to be 0.11. On the basis of CJ301 given above and according to Draize Dermal Classification System, the response of the test article was categorized as mild irritant.
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