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Diss Factsheets

Administrative data

Description of key information

The skin sensitization rate of CJ304 was 100% and CJ304 caused extreme skin 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 May 09, 2016 to September 26, 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: 6-7 weeks
- Weight at study initiation: 349-422g
- 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 of 50% (w/v) CJ304 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) CJ304
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:
negative control
Dose level:
0.4mL
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
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:
test chemical
Dose level:
0.4 mL of 50% (w/v) CJ304
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
One animal was found dead on Day 22.
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.4 mL of 50% (w/v) CJ304
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
One animal was found dead on Day 22.
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

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

31

1

374

438

Normal

D0-24

32

1

363

444

Normal

D0-24

33

1

374

470

Normal

D0-24

34

1

383

452

Normal

D0-24

35

1

354

419

Normal

D0-24

36

2

354

-

Normal

D0-21

Found dead

D22

37

2

393

482

Normal

D0-24

38

2

374

461

Normal

D0-24

39

2

384

483

Normal

D0-24

40

2

422

532

Normal

D0-24

41

2

388

459

Normal

D0-24

42

2

377

443

Normal

D0-24

43

2

349

398

Normal

D0-24

44

2

355

421

Normal

D0-24

45

2

366

436

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

31

1

ID_1

1/1

4/2

4/1

4/2

4/2

4/2

ID_2

0/0

0/0

0/0

0/0

0/0

2/2

ID_3

1/1

4/2

4/1

4/2

4/2

4/2

Topical

-

-

2/2

2/2

2/2

2/2

32

1

ID_1

1/1

4/1

4/1

4/2

4/2

4/2

ID_2

0/0

0/0

0/0

0/0

0/0

2/2

ID_3

1/1

4/1

4/1

4/2

4/2

4/2

Topical

-

-

2/2

2/2

2/2

2/2

33

1

ID_1

1/1

4/2

4/1

4/2

4/2

4/2

ID_2

1/0

0/0

0/0

0/0

0/0

0/0

ID_3

1/1

4/2

4/1

4/2

4/2

4/2

Topical

-

-

2/2

2/2

2/2

2/2

34

1

ID_1

1/1

4/2

4/2

4/2

4/2

4/2

ID_2

0/0

0/0

0/0

0/0

4/2

4/2

ID_3

1/1

4/2

4/2

4/2

4/2

4/2

Topical

-

-

2/2

2/2

2/2

2/2

35

1

ID_1

1/1

4/2

4/1

4/2

4/2

4/2

ID_2

0/0

0/0

0/0

0/0

0/0

0/0

ID_3

1/1

4/2

4/1

4/2

4/2

4/2

Topical

-

-

2/2

2/2

2/2

2/2

36

2

ID_1

0/0

4/2

4/2

4/2

4/2

4/2

ID_2

0/0

0/0

0/0

0/0

4/2

4/2

ID_3

0/0

4/2

4/2

4/2

4/2

4/2

Topical

-

-

2/2

2/2

2/2

2/2

37

2

ID_1

1/0

4/2

4/1

4/2

4/2

4/2

ID_2

0/0

0/0

0/0

0/0

0/0

2/2

ID_3

0/0

4/2

4/1

4/2

4/2

4/2

Topical

-

-

2/2

2/2

2/2

2/2

38

2

ID_1

1/0

4/2

4/1

4/2

4/2

4/2

ID_2

0/0

0/0

4/1

0/0

0/0

0/0

ID_3

0/0

4/2

4/1

4/2

4/2

4/2

Topical

-

-

2/2

2/2

2/2

2/2

39

2

ID_1

1/0

4/2

4/2

4/2

4/2

4/2

ID_2

0/0

0/0

4/2

0/0

0/0

2/2

ID_3

0/0

4/2

4/2

4/2

4/2

4/2

Topical

-

-

2/2

2/2

2/2

2/2

40

2

ID_1

1/0

4/2

4/2

4/2

4/2

4/2

ID_2

4/0

0/0

4/2

0/0

0/0

2/2

ID_3

4/0

4/2

4/2

4/2

4/2

4/2

Topical

-

-

2/2

2/2

2/2

2/2

41

2

ID_1

1/0

4/2

4/1

4/2

4/2

4/2

ID_2

4/0

0/0

4/1

0/0

0/0

2/2

ID_3

1/0

0/0

4/1

4/2

4/2

4/2

Topical

-

-

2/2

2/2

2/2

2/2

42

2

ID_1

1/0

4/0

4/2

4/2

4/2

4/2

ID_2

4/0

4/0

0/0

4/2

4/2

4/2

ID_3

0/0

0/0

4/1

4/2

4/2

4/2

Topical

-

-

2/2

2/2

2/2

2/2

43

2

ID_1

1/0

4/0

4/2

4/2

4/2

4/2

ID_2

4/0

4/0

4/2

4/2

4/2

4/2

ID_3

4/0

4/0

4/2

4/2

4/2

4/2

Topical

-

-

2/2

2/2

2/2

2/2

44

2

ID_1

1/0

4/0

4/2

4/2

4/2

4/2

ID_2

4/0

4/0

0/0

4/2

4/2

4/2

ID_3

0/0

0/0

4/2

4/2

4/2

4/2

Topical

-

-

2/2

2/2

2/2

2/2

45

2

ID_1

1/0

4/0

4/1

4/2

4/2

4/2

ID_2

4/0

4/0

4/1

4/2

4/2

4/2

ID_3

0/0

4/0

4/1

4/2

4/2

4/2

Topical

-

-

2/2

2/2

2/2

2/2

-: no observation was conducted

Table 3. Individual Sensitization Observation

Animal#

Group#

Score

24h

48h

31

1

0

0

32

1

0

0

33

1

0

0

34

1

0

0

35

1

0

0

36

2

-

-

37

2

0

1

38

2

3

3

39

2

2

1

40

2

0

1

41

2

0

1

42

2

3

3

43

2

2

2

44

2

3

3

45

2

2

2
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 CJ304 was 100% and CJ304 caused extreme sensitization in guinea pigs. Therefore, CJ304 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 T65315021-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 CJ304 show that test reliability criteria was met.

A 10% and 50% (w/v) CJ304 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) CJ304. The skin sensitization reactions were scored at approximately 24 and 48 hours after patch removal. One treated animal was found dead on Day 22 and the cause of death was unknown. 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 to the CJ304. Under the conditions of this study, CJ304 caused extreme sensitization in guinea pigs.

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

Skin sensitization

A 10% and 50% (w/v) CJ304 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) CJ304. The skin sensitization reactions were scored at approximately 24 and 48 hours after patch removal. One treated animal was found dead on Day 22 and the cause of death was unknown. 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 to the CJ304. Under the conditions of this study, CJ304 caused extreme sensitization in guinea pigs.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

CJ304 is found to be sensitising to skin in guinea pigs.