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EC number: 943-083-7 | CAS number: 118578-12-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From November 25, 2016 to March 30, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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:
- 2-{[4-chloro-6-({8-hydroxy-3,6-disulfo-7-[(1-sulfo-2-naphthyl)diazenyl]-1-naphthyl}amino)-1,3,5-triazin-2-yl]amino}-5-sulfobenzoic acid, lithium sodium salts
- EC Number:
- 943-083-7
- Cas Number:
- 118578-12-4
- Molecular formula:
- Not applicable; this UVCB substance contains: C30H15ClN7O15S4.xLi.yNa, (x + y) = 5; 0 < (x,y) < 5 with 911.8 < MW < 992.1 g/mol (UVCB substance), C30H16N7O16S4.xLi.yNa, (x + y) = 5; 0 < (x,y) < 5 with 893.4 < MW < 973.7 g/mol (UVCB substnace), C23H11Cl2N6O10S3.xLi.yNa, (x + y) = 3; 0 < (x,y) < 3 with 719.3 < MW < 767.4 g/mol (UVCB substnace), and traces of NaCl.
- IUPAC Name:
- 2-{[4-chloro-6-({8-hydroxy-3,6-disulfo-7-[(1-sulfo-2-naphthyl)diazenyl]-1-naphthyl}amino)-1,3,5-triazin-2-yl]amino}-5-sulfobenzoic acid, lithium sodium salts
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- - Source: National Laboratory Animal Center, Taipei, Taiwan
- Age: approximately 5 to 6 weeks
- Weight at study initiation: 316-384 g
- Housing: Every two animals were housed in a stainless steel wire mesh cage
- Acclimation period: 7 days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 50 ± 20%
- Photoperiod: 12-hrs dark / 12-hrs light
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Remarks:
- Water of Injection (WFI)
- Concentration / amount:
- 0.1 mL 4% (w/v) and 0.4 mL 5% (w/v) of CJ308 for intradermal and epicutaneous, respectively
- Day(s)/duration:
- Day0 and Day7 for intradermal and epicutaneous, respectively
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- Water for Injection (WFI)
- Concentration / amount:
- 0.2 mL 2.5% (w/v) of CJ308
- Day(s)/duration:
- Day21
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- For control group (Group #1): five
For treated group (Group #2): ten - Positive control substance(s):
- yes
- Remarks:
- α-Hexylcinnamaldehyde (HCA)
Results and discussion
- Positive control results:
- The latest results showed that positive control animals had shown maximum skin reactions of 2 and the sensitization rate of α-Hexylcinnamaldehyde (HCA) was 60%.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 % (w/v)
- No. with + reactions:
- 7
- Total no. in group:
- 9
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- water for injection
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 5% HCA
- No. with + reactions:
- 3
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Group #1: Control group
Group #2: Treated group
Table 1. Individual Body Weight and Clinical Observations
Animal# |
Group # |
Body Weight (g) |
Observation |
|
Day 0 |
Day 24 |
D0-24 |
||
01 |
1 |
357 |
491 |
Normal |
02 |
1 |
345 |
469 |
Normal |
03 |
1 |
316 |
413 |
Normal |
04 |
1 |
349 |
456 |
Normal |
05 |
1 |
362 |
483 |
Normal |
06 |
2 |
332 |
459 |
Normal |
07 |
2 |
351 |
434 |
Normal |
08 |
2 |
325 |
413 |
Normal |
09 |
2 |
319 |
419 |
Normal |
10 |
2 |
343 |
481 |
Normal |
11 |
2 |
373 |
483 |
Normal |
12 |
2 |
324 |
461 |
Normal |
13 |
2 |
342 |
465 |
Normal |
14 |
2 |
350 |
449 |
Normal |
15 |
2 |
384 |
- |
Normal |
-: data missing
Table 2. Individual Skin Reaction on Induction Sites
Animal# |
Group # |
Site |
Maximum score (Erythema / Edema) |
||||||
Study Day |
|||||||||
3 |
7 |
10 |
14 |
17 |
21 |
24 |
|||
01 |
1 |
ID_1 |
1 / 2 |
2 / 3 |
2 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 3 |
ID_2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
||
ID_3 |
0 / 1 |
2 / 3 |
2 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 3 |
||
Topical |
- |
- |
2 / 2 |
2 / 2 |
2 / 2 |
2 / 2 |
2 / 2 |
||
02 |
1 |
ID_1 |
0 / 1 |
2 / 3 |
3 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 3 |
ID_2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
||
ID_3 |
0 / 1 |
2 / 3 |
2 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 3 |
||
Topical |
- |
- |
2 / 2 |
2 / 3 |
2 / 2 |
2 / 3 |
2 / 2 |
||
03 |
1 |
ID_1 |
0 / 1 |
2 / 3 |
3 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
ID_2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
||
ID_3 |
0 / 1 |
2 / 4 |
3 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
||
Topical |
- |
- |
2 / 2 |
2 / 2 |
2 / 2 |
2 / 3 |
2 / 3 |
||
04 |
1 |
ID_1 |
0 / 1 |
2 / 3 |
3 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
ID_2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
||
ID_3 |
0 / 1 |
2 / 2 |
3 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
||
Topical |
- |
- |
2 / 2 |
2 / 3 |
2 / 2 |
2 / 2 |
2 / 3 |
||
05 |
1 |
ID_1 |
0 / 1 |
2 / 3 |
2 / 2 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
ID_2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
||
ID_3 |
0 / 1 |
2 / 3 |
2 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
||
Topical |
- |
- |
2 / 2 |
2 / 2 |
2 / 3 |
2 / 2 |
2 / 3 |
||
06 |
2 |
ID_1 |
0 / 1 |
2 / 3 |
2 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
ID_2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
||
ID_3 |
2 / 3 |
2 / 3 |
3 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
||
Topical |
- |
- |
2 / 2 |
2 / 2 |
2 / 2 |
2 / 2 |
2 / 3 |
||
07 |
2 |
ID_1 |
0 / 1 |
4 / 4 |
3 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
ID_2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
||
ID_3 |
0 / 1 |
3 / 4 |
3 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
||
Topical |
- |
- |
2 / 2 |
2 / 3 |
2 / 2 |
2 / 2 |
2 / 3 |
||
08 |
2 |
ID_1 |
1 / 2 |
3 / 3 |
2 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 3 |
ID_2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
||
ID_3 |
1 / 1 |
3 / 3 |
3 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
||
Topical |
- |
- |
2 / 2 |
2 / 2 |
2 / 2 |
2 / 2 |
2 / 2 |
||
09 |
2 |
ID_1 |
0 / 1 |
2 / 3 |
3 / 3 |
4 / 4 |
4 / 4 |
4 / 3 |
4 / 4 |
ID_2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
||
ID_3 |
2 / 3 |
3 / 3 |
3 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
||
Topical |
- |
- |
2 / 2 |
2 / 2 |
2 / 2 |
2 / 2 |
2 / 3 |
||
10 |
2 |
ID_1 |
1 / 2 |
2 / 3 |
2 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 3 |
ID_2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
||
ID_3 |
0 / 1 |
3 / 3 |
2 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
||
Topical |
- |
- |
2 / 2 |
2 / 2 |
2 / 2 |
2 / 2 |
2 / 3 |
||
11 |
2 |
ID_1 |
1 / 1 |
2 / 3 |
2 / 3 |
4 / 4 |
4 / 4 |
4 / 3 |
4 / 4 |
ID_2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
||
ID_3 |
0 / 1 |
3 / 3 |
3 / 3 |
4 / 4 |
4 / 4 |
4 / 3 |
4 / 4 |
||
Topical |
- |
- |
2 / 2 |
2 / 2 |
2 / 2 |
2 / 2 |
2 / 3 |
||
12 |
2 |
ID_1 |
0 / 1 |
3 / 3 |
2 / 3 |
4 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
ID_2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
||
ID_3 |
0 / 1 |
3 / 4 |
3 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
||
Topical |
- |
- |
2 / 2 |
2 / 1 |
2 / 3 |
2 / 3 |
2 / 3 |
||
13 |
2 |
ID_1 |
1 / 1 |
2 / 3 |
3 / 3 |
4 / 3 |
4 / 4 |
4 / 3 |
4 / 4 |
ID_2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
||
ID_3 |
1 / 1 |
3 / 4 |
3 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
||
Topical |
- |
- |
2 / 2 |
2 / 1 |
2 / 2 |
2 / 2 |
2 / 2 |
||
14 |
2 |
ID_1 |
1 / 1 |
3 / 3 |
2 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
ID_2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
||
ID_3 |
3 / 4 |
3 / 3 |
3 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
||
Topical |
- |
- |
2 / 2 |
2 / 2 |
2 / 3 |
2 / 3 |
2 / 3 |
||
15 |
2 |
ID_1 |
0 / 1 |
3 / 3 |
3 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
ID_2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
||
ID_3 |
0 / 1 |
3 / 3 |
3 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
||
Topical |
- |
- |
2 / 2 |
2 / 2 |
2 / 2 |
2 / 2 |
2 / 3 |
||
Table 3. Individual Sensitization Observation
Animal# |
Group # |
Score |
|
24h |
48h |
||
01 |
1 |
1 |
0 |
02 |
1 |
1 |
0 |
03 |
1 |
1 |
1 |
04 |
1 |
1 |
0 |
05 |
1 |
1 |
0 |
06 |
2 |
2 |
1 |
07 |
2 |
3 |
3 |
08 |
2 |
2 |
1 |
09 |
2 |
3 |
3 |
10 |
2 |
3 |
2 |
11 |
2 |
2 |
2 |
12 |
2 |
0 |
0 |
13 |
2 |
0 |
0 |
14 |
2 |
2 |
2 |
15 |
2 |
1 |
- |
-: data missing
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- According to OECD 406 test method and “Magnusson and Kligman Maximization Grading”, the sensitization rate of CJ308 was 78% and CJ308 caused strong sensitization in guinea pigs. Therefore, CJ308 was classed as category 1 based on GHS criteria.
- Executive summary:
This test using the procedures outlined in the QPS Taiwan Study Plan for T65316011-IR which is based on the SOP for the OECD 406 (CTPS-TE00516) and OECD 406 (OECD, 1992). The results of this OECD 406 test for CJ308 show that test reliability criteria was met.
A 4% and 5% CJ308 was used for intradermal injection and occlusively patched, respectively, to ten test guinea pigs to induce sensitization. The water for injection was used for similar injection and occlusively patched to five control guinea pigs. Following a recovery period, animals received a challenge patch with 2.5% CJ308. The skin sensitization reactions were scored at approximately 24 and 48 hours after patch removal. At the end of study, body weight increase was observed in all animals. During 48 hours after challenge exposure, 78% treated animals showed sensitization to the CJ308. Under the conditions of this study, CJ308 caused strong sensitization in guinea pigs.
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