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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From June 13, 2016 to November 01, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

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

Constituent 1
Chemical structure
Reference substance name:
Reaction products of 2,7-Naphthalenedisulfonic acid, 4-amino-6-[2-[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulfophenyl]diazenyl]-3-[2-(2,5-disulfophenyl)diazenyl]-5-hydroxy-, pentasodium salt and lithium chloride
Molecular formula:
Not applicable; this UVCB substance contains: C25H14ClN10O16S5.xLi.yNa, (x + y) = 5; 0 < (x,y) < 5 with 940.9 < MW < 1021.1 g/mol (UVCB substance), and traces of NaCl.
IUPAC Name:
Reaction products of 2,7-Naphthalenedisulfonic acid, 4-amino-6-[2-[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulfophenyl]diazenyl]-3-[2-(2,5-disulfophenyl)diazenyl]-5-hydroxy-, pentasodium salt and lithium chloride
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

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 at study initiation: 5-6 weeks
- Weight at study initiation: 308-377g
- Housing: Every two animals were housed in a stainless steel wire mesh cage
- Water: ad libitum
- Acclimation period: 8 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 of 10% (w/v) and 0.5 mL of 50% (w/v) CJ309 for intradeermal and epicutaneous, respectively
Day(s)/duration:
Day 0 and Day 7 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:
0.4mL of 50% (w/v) CJ309
Day(s)/duration:
Day 21
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Control group: 5
Treated group: 10
Details on study design:
In the pilot study, the 10% (w/v) of TA for intradermal induction was well-tolerated systemically and the highest concentration that caused mild-to-moderate skin irritation. The 50% (w/v) of TA used for topical induction and challenge was the highest concentration that can be applied to animal and also the nonirritant dose. The dosing route used in the induction and challenge is determined in OECD406.
Positive control substance(s):
yes
Remarks:
HCA(CAS No. 101-86-0)

Results and discussion

Positive control results:
The latest results showed that positive control animals had shown maximum skin reactions of 3 and the sensitization rate of HCA (CAS No. 101-86-0) was 80%.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.4 mL of 50% (w/v) CJ309
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
all treated animals got scores 1 to 3
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.4 mL of 50% (w/v) CJ309
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
all treated animals got scores 1 to 3
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.4 mL of 50% (w/v)
No. with + reactions:
4
Total no. in group:
5
Clinical observations:
scores 1
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.4 mL of 50% (w/v)
No. with + reactions:
1
Total no. in group:
5
Clinical observations:
scores 1
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

In the table, Group#1 and Group#2 were control group and treated group, respectively.

Table 1. Individual Body Weights and Clinical Observations

Animal#

Group#

Study Day

Observation

Days Seen

0

24

61

1

328

432

Normal

D0-24

62

1

318

391

Normal

D0-24

63

1

323

430

Normal

D0-24

64

1

342

434

Normal

D0-24

65

1

353

452

Normal

D0-24

66

2

308

389

Normal

D0-24

67

2

330

439

Normal

D0-24

68

2

334

417

Normal

D0-24

69

2

360

454

Normal

D0-24

70

2

361

444

Normal

D0-24

71

2

377

458

Normal

D0-24

72

2

334

437

Normal

D0-24

73

2

364

439

Normal

D0-24

74

2

353

471

Normal

D0-24

75

2

359

463

Normal

D0-24

Table 2. Individual Skin Reaction on Induction Sites

Animal#

Group#

Site

Maximum score (Erythema/Edema)

Study Day

1

5

10

12

15

19

61

1

ID_1

2/2

4/2

4/2

4/2

4/2

4/2

ID_2

0/0

0/2

2/2

0/0

0/0

0/2

ID_3

2/2

4/2

4/2

4/2

4/2

4/2

Topical

-

-

2/2

0/1

1/1

1/2

62

1

ID_1

2/2

4/2

4/2

4/2

4/2

4/2

ID_2

0/0

0/2

2/2

0/0

0/0

1/2

ID_3

2/2

4/2

4/2

4/2

4/2

4/2

Topical

-

-

2/2

0/1

1/1

2/2

63

1

ID_1

2/2

4/2

4/2

4/2

4/2

4/2

ID_2

0/0

0/2

2/1

0/0

0/0

2/2

ID_3

2/2

4/2

4/2

4/2

4/2

4/2

Topical

-

-

2/1

1/1

1/1

2/2

64

1

ID_1

1/2

4/2

4/1

4/2

4/2

4/2

ID_2

0/0

0/2

1/1

0/0

0/0

2/2

ID_3

1/2

4/2

4/1

4/2

4/2

4/2

Topical

-

-

1/1

1/1

1/1

2/2

65

1

ID_1

1/1

4/2

4/2

4/2

4/2

4/2

ID_2

0/0

0/2

2/2

0/0

0/0

2/2

ID_3

1/1

4/2

4/2

4/2

4/2

4/2

Topical

-

-

2/2

1/1

1/1

2/2

66

2

ID_1

NA/1

3/2

4/2

4/2

4/2

4/2

ID_2

NA/0

0/2

NA/NA

0/0

0/0

2/2

ID_3

NA/1

4/2

4/2

4/2

4/2

4/2

Topical

-

-

NA/NA

1/1

1/1

2/2

67

2

ID_1

NA/2

3/2

NA/NA

4/2

4/2

4/2

ID_2

NA/0

0/2

NA/NA

0/0

0/0

2/2

ID_3

NA/2

4/2

NA/NA

4/2

4/2

4/2

Topical

-

-

NA/NA

1/1

1/1

2/2

68

2

ID_1

1/1

3/2

4/NA

4/2

4/2

4/2

ID_2

NA/0

0/2

NA/NA

0/0

0/0

2/2

ID_3

NA/1

4/2

4/NA

4/2

4/2

4/2

Topical

-

-

NA/NA

1/1

1/1

2/2

69

2

ID_1

0/1

3/2

4/NA

4/2

4/2

4/2

ID_2

0/0

0/2

NA/NA

0/0

0/0

2/2

ID_3

0/2

4/2

4/NA

4/2

4/2

4/2

Topical

-

-

NA/NA

1/1

1/1

2/2

70

2

ID_1

1/1

3/2

4/2

4/2

4/2

4/2

ID_2

0/0

0/2

2/2

0/0

0/0

2/2

ID_3

NA/0

4/2

4/2

4/2

4/2

4/2

Topical

-

-

2/2

1/1

2/2

2/2

71

2

ID_1

0/1

2/2

4/2

4/2

4/2

4/2

ID_2

0/0

0/2

2/2

0/0

0/0

2/2

ID_3

NA/1

4/2

4/2

4/2

4/2

4/2

Topical

-

-

2/2

1/1

2/2

2/2

72

2

ID_1

NA/0

3/2

4/2

4/2

4/3

4/2

ID_2

0/0

0/2

NA/2

0/0

0/0

2/2

ID_3

NA/0

4/2

4/2

4/2

4/3

4/2

Topical

-

-

NA/2

1/1

2/2

2/2

73

2

ID_1

1/2

2/2

4/2

4/2

4/2

4/2

ID_2

0/0

0/2

NA/2

0/0

0/0

2/2

ID_3

NA/1

4/2

4/2

4/2

4/2

4/2

Topical

-

-

NA/2

1/1

1/2

2/2

74

2

ID_1

NA/1

4/2

4/2

4/2

4/2

4/2

ID_2

0/0

0/2

0/2

0/0

0/0

3/2

ID_3

NA/0

4/2

4/2

4/2

4/2

4/2

Topical

-

-

0/2

1/1

1/1

2/2

75

2

ID_1

NA/1

2/2

4/2

4/2

4/2

4/2

ID_2

0/0

0/2

2/2

0/0

0/0

2/2

ID_3

NA/0

4/2

4/2

4/2

4/2

4/2

Topical

-

-

2/2

1/1

2/2

2/2

-: no observation was conducted

NA: the site could not be observed because test article stain

Table 3. Individual Sensitization Observation

Animal#

Group#

Score

24h

48h

61

1

1

0

62

1

1

0

63

1

0

0

64

1

1

0

65

1

1

1

66

2

1

1

67

2

2

2

68

2

2

2

69

2

2

2

70

2

2

2

71

2

2

2

72

2

2

1

73

2

2

1

74

2

1

1

75

2

2

2

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 Grsding, the sensitization rate of CJ309 was 80% and CJ309 caused strong sensitization in guinea pigs. Therefore, CJ309 was categorized as indication of skin sensitising (Category 1) based on GHS criteria.
Executive summary:

This test using the procedures outlined in the QPS Taiwan Study Plan for T65315023-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 CJ309 show that test reliability criteria was met.

A 10% and 50% (w/v) CJ309 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 50% (w/v) CJ309. The skin sensitization reactions were scored at approximately 24 and 48 hours after patch removal. No test article-related adverse systemic effects were observed clinically in surviving animals during the study period. At the end of study, body weight increase was observed in all surviving animals. During 48 hours after challenge exposure, 80% treated animals showed sensitization to the CJ309. Under the conditions of this study, CJ309 caused strong sensitization in guinea pigs.