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EC number: - | CAS number: -
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:
- Reaction products of 1,4-Benzenedisulfonic acid, 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulfo-1-naphthalenyl]azo]sulfo-1-naphthalenyl]azo]-, tetrasodium salt and lithium chloride
- Molecular formula:
- Not applicable; this UVCB substance contains: C29H16ClN9O12S4.xLi.yNa, (x + y) = 4; 0 < (x,y) < 4 with 873.9 < MW < 938.1 g/mol (UVCB substance), and traces of NaCl.
- IUPAC Name:
- Reaction products of 1,4-Benzenedisulfonic acid, 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulfo-1-naphthalenyl]azo]sulfo-1-naphthalenyl]azo]-, tetrasodium salt and lithium chloride
- 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: 300-361 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 for injection (WFI)
- Concentration / amount:
- 0.1 mL 10 % (w/v) and 0.4 mL 25 % (w/v) of CJ313 for intradermal and epicutaneous, respectively
- Day(s)/duration:
- D0 and D7 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 CJ313
- Day(s)/duration:
- D21
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- For Control group: five
For Treated group: 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:
- 24
- Group:
- negative control
- Dose level:
- 0.4 mL
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- The skin sensitizing potential of the test article was evaluated according to the reactions observed in each control and treated animal. Since the score=1 was seen in control animals, sensitizing score >1 in the treated animals represented sensitization.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.4 mL
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- The skin sensitizing potential of the test article was evaluated according to the reactions observed in each control and treated animal. Since the score=1 was seen in control animals, sensitizing score >1 in the treated animals represented sensitization.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.4 mL of 25%(w/v) CJ313
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- The skin sensitizing potential of the test article was evaluated according to the reactions observed in each control and treated animal. Since the score=1 was seen in control animals, sensitizing score >1 in the treated animals represented sensitization.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.4 mL of 25%(w/v) CJ313
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- The skin sensitizing potential of the test article was evaluated according to the reactions observed in each control and treated animal. Since the score=1 was seen in control animals, sensitizing score >1 in the treated animals represented sensitization.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- not measured/tested
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 |
||
16 |
1 |
324 |
464 |
Normal |
17 |
1 |
318 |
464 |
Normal |
18 |
1 |
352 |
462 |
Normal |
19 |
1 |
361 |
465 |
Normal |
20 |
1 |
342 |
455 |
Normal |
21 |
2 |
310 |
427 |
Normal |
22 |
2 |
342 |
440 |
Normal |
23 |
2 |
308 |
427 |
Normal |
24 |
2 |
346 |
464 |
Normal |
25 |
2 |
333 |
449 |
Normal |
26 |
2 |
330 |
415 |
Normal |
27 |
2 |
339 |
470 |
Normal |
28 |
2 |
325 |
442 |
Normal |
29 |
2 |
300 |
380 |
Normal |
30 |
2 |
333 |
452 |
Normal |
Table 2. Individual Skin Reaction on Induction Sites
Animal# |
Group # |
Site |
Maximum score (Erythema / Edema) |
||||||
Study Day |
|||||||||
3 |
7 |
10 |
14 |
17 |
21 |
24 |
|||
16 |
1 |
ID_1 |
0 / 1 |
2 / 3 |
2 / 2 |
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 / 1 |
2 / 1 |
2 / 2 |
2 / 2 |
2 / 2 |
||
17 |
1 |
ID_1 |
0 / 1 |
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 |
3 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 3 |
||
Topical |
- |
- |
2 / 1 |
2 / 1 |
2 / 2 |
2 / 2 |
2 / 2 |
||
18 |
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 |
3 / 3 |
2 / 2 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
||
Topical |
- |
- |
2 / 1 |
2 / 2 |
2 / 2 |
2 / 2 |
2 / 2 |
||
19 |
1 |
ID_1 |
0 / 1 |
2 / 3 |
3 / 3 |
4 / 4 |
4 / 4 |
4 / 3 |
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 / 3 |
4 / 3 |
||
Topical |
- |
- |
2 / 1 |
2 / 1 |
2 / 2 |
2 / 2 |
2 / 3 |
||
20 |
1 |
ID_1 |
0 / 1 |
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 / 3 |
||
Topical |
- |
- |
1 / 1 |
1 / 1 |
2 / 2 |
2 / 2 |
2 / 2 |
||
21 |
2 |
ID_1 |
0 / 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 |
0 / 1 |
3 / 4 |
3 / 4 |
4 / 4 |
4 / 4 |
4 / 3 |
4 / 4 |
||
Topical |
- |
- |
2 / 2 |
2 / 2 |
2 / 2 |
2 / 2 |
2 / 3 |
||
22 |
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 |
0 / 1 |
3 / 3 |
2 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
||
Topical |
- |
- |
2 / 1 |
2 / 2 |
2 / 2 |
2 / 2 |
2 / 3 |
||
23 |
2 |
ID_1 |
0 / 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 |
0 / 1 |
3 / 3 |
2 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
||
Topical |
- |
- |
2 / 1 |
2 / 1 |
2 / 3 |
2 / 3 |
2 / 3 |
||
24 |
2 |
ID_1 |
0 / 0 |
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 |
2 / 3 |
2 / 3 |
4 / 4 |
2 / 3 |
4 / 3 |
4 / 4 |
||
Topical |
- |
- |
2 / 1 |
2 / 1 |
2 / 2 |
2 / 3 |
2 / 3 |
||
25 |
2 |
ID_1 |
2 / 2 |
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 / 4 |
3 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
||
Topical |
- |
- |
2 / 1 |
2 / 1 |
2 / 2 |
2 / 3 |
2 / 3 |
||
26 |
2 |
ID_1 |
1 / 2 |
3 / 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 |
3 / 3 |
3 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
||
Topical |
- |
- |
2 / 1 |
2 / 2 |
2 / 3 |
2 / 3 |
2 / 3 |
||
27 |
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 / 4 |
2 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
||
Topical |
- |
- |
2 / 1 |
2 / 1 |
2 / 3 |
2 / 3 |
2 / 3 |
||
28 |
2 |
ID_1 |
0 / 1 |
2 / 2 |
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 / 0 |
3 / 3 |
2 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
||
Topical |
- |
- |
2 / 2 |
2 / 2 |
2 / 2 |
2 / 3 |
2 / 3 |
||
29 |
2 |
ID_1 |
0 / 1 |
2 / 3 |
2 / 2 |
4 / 4 |
4 / 3 |
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 |
3 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 3 |
||
Topical |
- |
- |
2 / 1 |
2 / 1 |
2 / 2 |
2 / 2 |
2 / 3 |
||
30 |
2 |
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 |
3 / 3 |
2 / 3 |
4 / 4 |
4 / 4 |
4 / 4 |
4 / 4 |
||
Topical |
- |
- |
2 / 1 |
2 / 1 |
2 / 2 |
2 / 3 |
2 / 2 |
||
Table 3. Individual Sensitization Observation
Animal# |
Group # |
Score |
|
24h |
48h |
||
16 |
1 |
0 |
1 |
17 |
1 |
1 |
1 |
18 |
1 |
0 |
0 |
19 |
1 |
1 |
0 |
20 |
1 |
1 |
0 |
21 |
2 |
1 |
1 |
22 |
2 |
2 |
1 |
23 |
2 |
2 |
1 |
24 |
2 |
1 |
1 |
25 |
2 |
1 |
2 |
26 |
2 |
1 |
1 |
27 |
2 |
1 |
1 |
28 |
2 |
0 |
0 |
29 |
2 |
0 |
0 |
30 |
2 |
0 |
0 |
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 CJ313 was 30% and CJ313 caused moderate sensitization in guinea pigs. Therefore, CJ313 was category 1 based on GHS criteria.
- Executive summary:
This test using the procedures outlined in the QPS Taiwan Study Plan for T65316012-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 CJ313 show that test reliability criteria was met.
A 10% and 25% CJ313 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% CJ313. 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, 30% treated animals showed sensitization to the CJ313. Under the conditions of this study, CJ313 caused moderate sensitization in guinea pigs.
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