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Diss Factsheets

Administrative data

Description of key information

According to OECD 406 test method and Magnusson and Kligman Maximization Grading, the sensitization rate was 100%. Therefore, the substance was categorized as indication skin sensitising potential based on GHS criteria.

The induction concentrations were > 1% so cannot be determined if 1A or 1B.

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
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.
Specific details on test material used for the study:
Date of receipt 26 October 2015
Source Supplied by sponsor
Batch/Lot number 5507
Storage conditions 2-8 °C
Physical appearance Orange-yellow powder
Expiration date 30 September 2017
Species:
guinea pig
Strain:
Hartley
Sex:
male
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: 302-383g
- Housing: Every two animals were housed in a stainless steel wire mesh cage
- Water: ad libitum
- Acclimation period: 7 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:
0.1mL of 10% (w/v) and 0.5 mL 50% (w/v) CJ301 for intradermal and epicutaneous, respectively
Day(s)/duration:
Day 0 and Day 7 for intraderma 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 50% (w/v) CJ301
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:
historical controls 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:
test chemical
Dose level:
0.4 mL 50% (w/v)
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 50% (w/v)
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
Scores 1 to 3
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.4 mL 50% (w/v)
No. with + reactions:
0
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 50% (w/v)
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no 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

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

1

1

319

415

Normal

D0-24

2

1

316

385

Normal

D0-24

3

1

370

435

Normal

D0-24

4

1

375

457

Normal

D0-24

5

1

383

537

Normal

D0-24

6

2

322

404

Normal

D0-24

7

2

335

441

Normal

D0-24

8

2

354

420

Normal

D0-24

9

2

381

440

Normal

D0-24

10

2

325

412

Normal

D0-24

11

2

302

395

Normal

D0-24

12

2

320

401

Normal

D0-24

13

2

307

412

Normal

D0-24

14

2

370

476

Normal

D0-24

15

2

358

430

Normal

D0-24

Table 2. Individual Skin Reaction on Induction Sites; Three induction sites used

ID 1 = Freunds Complete Adjuvant in water

ID 2 = Test material in water (just water for controls)

ID 3 = Test material in water with FCA (FCA and water only in control)

Animal#

Group#

Site

Maximum score (Erythema/Edema)

Study Day

1

2

5

7

12

15

19

1

1

ID_1

2/2

2/2

4/2

4/2

4/2

4/2

4/2

ID_2

0/0

0/0

0/0

0/0

0/0

0/0

0/0

ID_3

2/2

2/2

2/2

4/2

4/2

4/2

4/2

Topical

-

-

-

-

2/2

2/2

2/2

2

1

ID_1

2/2

2/2

2/2

4/2

4/2

4/2

4/2

ID_2

0/0

0/0

0/0

0/0

0/0

0/0

0/0

ID_3

2/2

2/2

4/2

4/2

4/2

4/2

4/2

Topical

-

-

-

-

2/2

2/2

2/2

3

1

ID_1

2/2

2/2

4/2

4/2

4/2

4/2

4/2

ID_2

0/0

0/0

0/0

0/0

0/0

0/0

0/0

ID_3

2/2

2/2

4/2

4/2

4/2

4/2

4/2

Topical

-

-

-

-

2/2

2/2

2/2

4

1

ID_1

2/2

2/2

3/2

4/2

4/2

4/2

4/2

ID_2

0/0

0/0

0/0

0/0

0/0

0/0

0/0

ID_3

2/2

2/2

3/2

4/2

4/2

4/2

4/2

Topical

-

-

-

-

2/2

2/2

2/2

5

1

ID_1

2/2

2/2

4/2

4/2

4/2

4/2

4/2

ID_2

0/0

0/0

0/0

0/0

0/0

0/0

0/0

ID_3

2/2

2/2

4/2

4/2

4/2

4/2

4/2

Topical

-

-

-

-

2/2

2/2

2/2

6

2

ID_1

-

2/2

4/2

4/2

4/2

4/2

4/2

ID_2

-

0/0

0/0

0/0

0/0

0/0

0/0

ID_3

-

NA/2

4/2

4/2

4/2

4/2

4/2

Topical

-

-

-

-

2/2

2/2

2/2

7

2

ID_1

-

2/2

4/2

4/2

4/2

4/2

4/2

ID_2

-

0/0

0/0

0/0

0/0

0/0

0/0

ID_3

-

NA/2

4/2

4/2

4/2

4/2

4/2

Topical

-

-

-

-

2/2

2/2

2/2

8

2

ID_1

-

2/2

4/2

4/2

4/2

4/2

4/2

ID_2

-

0/0

0/0

0/0

0/0

0/0

0/0

ID_3

-

NA/2

4/2

4/2

4/2

4/2

4/2

Topical

-

-

-

-

2/2

2/2

2/2

9

2

ID_1

-

2/2

4/2

4/2

4/2

4/2

4/2

ID_2

-

0/0

0/0

0/0

0/0

0/0

0/0

ID_3

-

3/2

4/2

4/2

4/2

4/2

4/2

Topical

-

-

-

-

2/2

4/2

4/2

10

2

ID_1

-

2/2

4/2

4/2

4/2

4/2

4/2

ID_2

-

0/0

0/0

0/0

0/0

0/0

0/0

ID_3

-

NA/2

4/2

4/2

4/2

4/2

4/2

Topical

-

-

-

-

2/2

2/2

2/2

11

2

ID_1

-

2/2

4/2

4/2

4/2

4/2

4/2

ID_2

-

0/0

0/0

0/0

0/0

0/0

0/0

ID_3

-

3/2

4/2

4/2

4/2

4/2

4/2

Topical

-

-

-

-

2/2

2/2

2/2

12

2

ID_1

-

2/2

4/2

4/2

4/2

4/2

4/2

ID_2

-

0/0

0/0

0/0

4/2

4/2

4/2

ID_3

-

NA/2

4/2

4/2

4/2

4/2

4/2

Topical

-

-

-

-

4/2

4/2

4/2

13

2

ID_1

-

2/2

4/2

4/2

4/2

4/2

4/2

ID_2

-

0/0

0/0

0/0

0/0

0/0

0/0

ID_3

-

NA/2

4/2

4/2

4/2

4/2

4/2

Topical

-

-

-

-

2/2

2/2

2/2

14

2

ID_1

-

2/2

4/2

4/2

4/2

4/2

4/2

ID_2

-

0/0

0/0

0/0

0/0

0/0

0/0

ID_3

-

NA/2

4/2

4/2

4/2

4/2

4/2

Topical

-

-

-

-

2/2

2/2

2/2

15

2

ID_1

-

2/2

3/2

4/2

4/2

4/2

4/2

ID_2

-

0/0

0/0

0/0

0/0

0/0

0/0

ID_3

-

3/2

4/2

4/2

4/2

4/2

4/2

Topical

-

-

-

-

2/2

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

1

1

0

0

2

1

0

0

3

1

0

0

4

1

0

0

5

1

0

0

6

2

3

3

7

2

3

3

8

2

2

2

9

2

3

3

10

2

1

1

11

2

0

1

12

2

3

3

13

2

3

3

14

2

2

2

15

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 Grading, the sensitization rate was 100%. Therefore, the substance was categorized as indication skin sensitising potential based on GHS criteria.

The induction concentrations were > 1% so cannot be determined if 1A or 1B.
Executive summary:

This test using the procedures outlined in the QPS Taiwan Study Plan for T65315019-IR which is based on the SOP for the OECD 406 (CTPS-TE00516) and OECD 406 (OECD, 1992). The results of this OECD 221 test show that test reliability criteria was met.

A 10% and 50% (w/v) CJ301 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) . 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, 100% treated animals showed sensitization .

Under the conditions of this study there was sensitization in guinea pigs.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

A 10% and 50% (w/v) 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). 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, 100% treated animals showed sensitization.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification