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EC number: 276-982-1 | CAS number: 72905-97-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-01-14~2015-02-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The guinea pig maximization test (GPMT) is already available for the registration outside of EU. Therefore, LLNA is not conducted.
Test material
- Reference substance name:
- Cuprate(4-), [μ-[[3,3'-[azobis[(2-hydroxy-4,1-phenylene)azo]]bis[4-hydroxy-6-[(3-sulfophenyl)amino]-2-naphthalenesulfonato]](8-)]]di-, ammonium sodium
- EC Number:
- 276-982-1
- EC Name:
- Cuprate(4-), [μ-[[3,3'-[azobis[(2-hydroxy-4,1-phenylene)azo]]bis[4-hydroxy-6-[(3-sulfophenyl)amino]-2-naphthalenesulfonato]](8-)]]di-, ammonium sodium
- Cas Number:
- 72905-97-6
- Molecular formula:
- C44H24Cu2N8O17S4.xNa xNH4, x=0~4 , typical x=2
- IUPAC Name:
- Cuprate(4-), [μ-[[3,3'-[azobis[(2-hydroxy-4,1-phenylene)azo]]bis[4-hydroxy-6-[(3-sulfophenyl)amino]-2-naphthalenesulfonato]](8-)]]di-, ammonium sodium
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report):Everdirect SH14(DBk112)
- Substance type:Powder
- Composition of test material, percentage of components:88.53%
- Lot/batch No.:4401
- Expiration date of the lot/batch:2016-10-31
- Storage condition of test material:Refrigeration(5 ± 3℃)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- For pilot study : 12%, 10%, 8% and 6%
For main study : 12%
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- For pilot study : 12%, 10%, 8% and 6%
For main study : 12%
- No. of animals per dose:
- For pilot study : three
For main study : Control group:five ; Test group:ten
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 12% of test article
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No visible change
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 12% of test article. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No visible change.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 12% of test article
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No visible change
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 12% of test article. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No visible change.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 12% of test article
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No visible change
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 12% of test article. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No visible change.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 12% of test article
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No visible change
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 12% of test article. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No visible change.
Any other information on results incl. tables
Table 1 : Result of pilot study
Treatment |
Animal ID. |
Sex |
Grade of skin reaction/Concentration of test article |
|||||||
24 hrs |
48 hrs |
|||||||||
12% |
10% |
8% |
6% |
12% |
10% |
8% |
6% |
|||
Intradermal injection |
01 |
Male |
0 |
0 |
0 |
NA |
0 |
0 |
0 |
NA |
Epidermal application |
02 |
Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
03 |
Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Table 2 : The body weight of the guinea pigs
Group |
Sex |
Animal ID. |
Animal Weight (g) |
Weighy Change (g) |
|
Day 1 |
Day 26 |
||||
Control group |
Male |
391 |
356.6 |
503.4 |
+146.8 |
392 |
326.2 |
485.4 |
+159.2 |
||
393 |
343.8 |
506.4 |
+162.6 |
||
394 |
344.8 |
489.6 |
+144.8 |
||
395 |
341.8 |
500.8 |
+159.0 |
||
Test group |
Male |
396 |
337.4 |
494.6 |
+157.2 |
397 |
361.2 |
482.4 |
+121.2 |
||
398 |
367.8 |
522.0 |
+154.2 |
||
399 |
345.8 |
480.6 |
+134.8 |
||
400 |
366.8 |
507.4 |
+140.6 |
||
401 |
335.4 |
480.4 |
+145.0 |
||
402 |
343.8 |
496.6 |
+152.8 |
||
403 |
331.8 |
492.8 |
+161.0 |
||
404 |
351.8 |
520.8 |
+169.0 |
||
405 |
354.6 |
484.9 |
+130.3 |
||
Table 3 : Individual skin reaction of guinea pigs
Group |
Sex |
Animal ID. |
Grade of skin reaction |
Percent of Animals Sensitized |
Sensitizing Capacity |
|
24 hrs |
48 hrs |
|||||
Control group |
Male |
391 |
0 |
0 |
0% |
Weak |
392 |
0 |
0 |
||||
393 |
0 |
0 |
||||
394 |
0 |
0 |
||||
395 |
0 |
0 |
||||
Teat group |
Male |
396 |
0 |
0 |
0% |
Weak |
397 |
0 |
0 |
||||
398 |
0 |
0 |
||||
399 |
0 |
0 |
||||
400 |
0 |
0 |
||||
401 |
0 |
0 |
||||
402 |
0 |
0 |
||||
403 |
0 |
0 |
||||
404 |
0 |
0 |
||||
405 |
0 |
0 |
||||
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- A challenge application was performed on the upper flank. Any skin reaction present in the treated areas was observed and recorded at 24 and 48 hours after the challenge. Results indicated that neither the test group nor the control group guinea pigs exhibited a hypersensitivity response on upper flank skin after application of the challenge does (0% sensitized).
- Executive summary:
According to OECD Guideline 406 (Skin Sensitisation), this test article was classified as having weak allergenic potential. The test result is "not sensitising", so that hazard category in CLP is not classified.
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