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Diss Factsheets

Administrative data

Description of key information

The skin sensitization rate of CJ312 was 50% and CJ312 cause caused moderate sensitization in guinea pigs. (OECD TG406).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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.
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: 336-413g
- 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
Route:
intradermal and epicutaneous
Vehicle:
water
Remarks:
water for injection (WFI)
Concentration / amount:
0.1 mL of 10% (w/v) and 0.5 mL 50% (w/v) CJ312 for intradermal 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
Route:
epicutaneous, occlusive
Vehicle:
water
Remarks:
water for injection (WFI)
Concentration / amount:
0.4 mL of 50% (w/v) CJ312
Day(s)/duration:
Day 21
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Control group: five
Treated group: ten
Positive control substance(s):
yes
Remarks:
HCA (CAS No. 101-86-0)
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%.
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
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.4 mL
No. with + reactions:
3
Total no. in group:
5
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:
2
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.4 mL of 50%(w/v) CJ312
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
The challenge site of control animals presented 0-2 grade and five treated animals got scores 3 within 24 hours after challenge exposure. The sensitization rate was 50% and indicated that the test article caused moderate sensitization.
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.4 mL of 50%(w/v) CJ312
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
The challenge site of control animals presented 0-2 grade and five treated animals got scores 3 within 48 hours after challenge exposure. The sensitization rate was 50% and indicated that the test article caused moderate sensitization.
Remarks on result:
positive indication of skin sensitisation

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

76

1

367

442

Normal

D0-24

77

1

343

404

Normal

D0-24

78

1

362

459

Normal

D0-24

79

1

347

430

Normal

D0-24

80

1

367

431

Normal

D0-24

81

2

413

473

Normal

D0-21

82

2

377

411

Normal

D0-24

83

2

356

447

Normal

D0-24

84

2

361

459

Normal

D0-24

85

2

336

426

Normal

D0-24

86

2

354

460

Normal

D0-24

87

2

350

461

Normal

D0-24

88

2

358

457

Normal

D0-24

89

2

376

455

Normal

D0-24

90

2

361

472

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

76

1

ID_1

2/2

2/2

4/1

4/2

4/2

4/2

ID_2

0/0

0/0

2/1

0/2

0/1

2/2

ID_3

2/2

4/2

4/1

4/2

4/2

4/2

Topical

-

-

2/1

2/2

2/2

2/2

77

1

ID_1

2/2

4/2

4/1

4/2

4/2

4/2

ID_2

0/0

0/0

2/1

0/2

0/1

2/2

ID_3

2/2

4/2

4/1

4/2

4/2

4/2

Topical

-

-

2/1

2/2

2/2

2/2

78

1

ID_1

2/2

4/2

4/1

4/2

4/2

4/2

ID_2

0/0

0/0

1/1

0/2

2/2

2/2

ID_3

2/2

4/2

4/1

4/2

4/2

4/2

Topical

-

-

1/1

2/2

2/2

2/2

79

1

ID_1

2/2

2/1

4/1

4/2

4/2

4/2

ID_2

0/0

0/0

1/1

0/2

0/2

2/2

ID_3

2/2

4/2

4/1

4/2

4/2

4/2

Topical

-

-

1/1

2/2

2/2

2/2

80

1

ID_1

2/2

4/2

4/2

4/2

4/2

4/2

ID_2

0/0

0/0

2/2

0/2

0/2

2/2

ID_3

2/2

4/2

4/2

4/2

4/2

4/2

Topical

-

-

2/2

2/2

2/2

2/2

81

2

ID_1

1/1

4/2

4/3

4/2

4/2

4/2

ID_2

0/0

0/0

4/3

4/2

4/2

3/2

ID_3

0/1

4/2

4/3

4/2

4/2

4/2

Topical

-

-

4/3

4/2

3/2

3/2

82

2

ID_1

0/1

4/2

4/3

4/2

4/2

4/2

ID_2

0/0

0/0

4/3

4/2

4/2

4/2

ID_3

0/1

4/2

4/3

4/2

4/2

4/2

Topical

-

-

4/3

4/2

4/2

4/2

83

2

ID_1

2/1

2/1

4/3

4/2

4/2

4/2

ID_2

0/0

0/0

4/3

4/2

0/2

2/2

ID_3

0/0

4/2

4/3

4/2

4/2

4/2

Topical

-

-

4/3

3/2

3/2

2/2

84

2

ID_1

2/1

4/2

4/3

4/2

4/2

4/2

ID_2

0/0

0/0

2/3

0/2

0/2

2/2

ID_3

1/1

4/2

4/3

4/2

4/2

4/2

Topical

-

-

2/3

2/2

2/2

2/2

85

2

ID_1

2/2

3/2

4/2

4/2

4/2

4/2

ID_2

0/0

0/0

2/2

4/2

2/2

2/2

ID_3

2/2

4/2

4/2

4/2

4/2

4/2

Topical

-

-

2/2

3/2

4/2

2/2

86

2

ID_1

2/1

4/2

4/2

4/2

4/2

4/2

ID_2

0/0

0/0

2/2

3/2

0/2

2/2

ID_3

0/1

4/2

4/2

4/2

4/2

4/2

Topical

-

-

2/2

3/2

4/2

3/2

87

2

ID_1

3/2

2/1

4/2

4/2

4/2

4/2

ID_2

0/0

0/0

2/2

0/2

0/2

2/2

ID_3

2/2

4/2

4/2

4/2

4/2

4/2

Topical

-

-

2/2

3/2

3/2

2/2

88

2

ID_1

2/2

3/1

4/2

4/2

4/2

4/2

ID_2

0/0

0/0

2/2

3/2

2/2

4/2

ID_3

NA/2

4/2

4/2

4/2

4/2

4/2

Topical

-

-

2/2

2/2

4/2

2/2

89

2

ID_1

1/1

4/2

4/3

4/2

4/2

4/2

ID_2

0/0

0/0

2/3

3/2

2/2

2/2

ID_3

1/1

4/2

4/3

4/2

4/3

4/2

Topical

-

-

2/3

3/2

4/2

4/2

90

2

ID_1

1/0

4/2

4/1

4/2

4/2

4/2

ID_2

0/0

0/0

4/1

2/2

0/2

2/2

ID_3

0/0

4/2

4/1

4/2

4/2

4/2

Topical

-

-

1/1

2/2

2/2

1/2

-: 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

76

1

0

0

77

1

0

0

78

1

1

0

79

1

1

1

80

1

2

2

81

2

3

3

82

2

3

3

83

2

3

3

84

2

3

3

85

2

3

3

86

2

1

1

87

2

2

1

88

2

1

2

89

2

0

1

90

2

1

1
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 CJ312 was 50% and CJ312 caused moderate sensitization in guinea pigs. Therefore, CJ312 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 T65315024-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 CJ312 show that test reliability criteria was met.

A 10% and 50% (w/v) CJ312 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) CJ312. 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, 50% treated animals showed sensitization to the CJ312. Under the conditions of this study, CJ312 caused moderate sensitization in guinea pigs.

 

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Additional information:

Skin sensitization

A 10% and 50% (w/v) CJ312 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) CJ312. 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, 50% treated animals showed sensitization to the CJ312. Under the conditions of this study, CJ312 caused moderate sensitization in guinea pigs.

Justification for classification or non-classification