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Administrative data

Description of key information

Skin sensitization

The sensitization rate of CR SB32N2 was 0% and CR SB32N2 caused weak 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 December 23, 2016 to March 30, 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
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: approximately 5 to 6 weeks
- Weight at study initiation: 314-399 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
Route:
intradermal and epicutaneous
Vehicle:
water
Remarks:
water for injection (WFI)
Concentration / amount:
0.1 mL of 10% and 0.4 mL of 50 % CR SB32N2 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:
0.2 mL of 10 % CR SB32N2
Day(s)/duration:
Day21
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)
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%.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
10% CR SB32N2
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
Water for injection
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
50% HCA
No. with + reactions:
3
Total no. in group:
5
Remarks on result:
positive indication of skin sensitisation

Group #1: Control group

Group #2: Treated group

 

Table 1. Individual Body Weightand Clinical Observations

Animal#

Group #

Body Weight (g)

Observation

Day 0

Day 24

D0-24

16

1

333

433

Normal

17

1

339

455

Normal

18

1

358

477

Normal

19

1

370

487

Normal

20

1

348

426

Normal

21

2

353

437

Normal

22

2

355

416

Normal

23

2

323

419

Normal

24

2

322

388

Normal

25

2

399

524

Normal

26

2

354

455

Normal

27

2

339

441

Normal

28

2

314

394

Normal

29

2

330

437

Normal

30

2

348

443

Normal

*On Day 1 and Day 21, pink colored skin or urine were observed in some treated animals.

 

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 / 2

4 / 3

4 / 3

4 / 4

4 / 2

4 / 2

ID_2

0 / 0

0 / 0

0 / 0

0 / 0

0 / 0

0 / 0

0 / 0

ID_3

0 / 1

3 / 2

4 / 3

4 / 3

4 / 3

4 / 2

4 / 2

Topical

-

-

2 / 2

2 / 2

2 / 3

2 / 2

2 / 2

17

1

ID_1

2 / 2

3 / 2

4 / 3

4 / 3

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

3 / 2

4 / 3

3 / 3

4 / 4

4 / 3

4 / 3

Topical

-

-

2 / 3

2 / 2

2 / 2

2 / 3

2 / 3

18

1

ID_1

0 / 1

3 / 3

3 / 2

4 / 3

4 / 3

4 / 2

4 / 2

ID_2

0 / 0

0 / 0

0 / 0

0 / 0

0 / 0

0 / 0

0 / 0

ID_3

0 / 1

3 / 3

4 / 2

4 / 3

4 / 4

4 / 2

4 / 2

Topical

-

-

1 / 2

2 / 2

2 / 3

2 / 2

2 / 2

19

1

ID_1

0 / 1

3 / 2

4 / 2

4 / 3

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

3 / 2

4 / 2

4 / 3

4 / 4

4 / 3

4 / 3

Topical

-

-

2 / 2

2 / 2

2 / 3

2 / 3

2 / 3

20

1

ID_1

0 / 1

3 / 2

4 / 3

4 / 3

4 / 3

4 / 3

4 / 3

ID_2

0 / 0

0 / 0

0 / 0

0 / 0

0 / 0

0 / 0

0 / 0

ID_3

0 / 1

3 / 2

4 / 3

4 / 3

4 / 3

4 / 3

4 / 3

Topical

-

-

2 / 2

2 / 2

2 / 2

2 / 3

2 / 3

21

2

ID_1

0 / 1

3 / 2

4 / 3

4 / 3

4 / 4

4 / 2

4 / 2

ID_2

2 / 1

2 / 2

0 / 0

0 / 0

0 / 0

0 / 0

0 / 0

ID_3

2 / 1

4 / 3

4 / 4

4 / 4

4 / 4

4 / 2

4 / 2

Topical

-

-

2 / 3

2 / 3

3 / 3

3 / 2

3 / 2

22

2

ID_1

0 / 1

3 / 2

4 / 3

4 / 4

4 / 3

4 / 3

4 / 3

ID_2

2 / 1

2 / 2

4 / 3

4 / 4

4 / 3

4 / 2

4 / 2

ID_3

3 / 1

4 / 3

4 / 4

4 / 4

4 / 4

4 / 2

4 / 2

Topical

-

-

2 / 3

4 / 3

3 / 3

2 / 3

2 / 3

23

2

ID_1

0 / 1

3 / 3

4 / 3

4 / 4

4 / 4

4 / 3

4 / 3

ID_2

0 / 0

3 / 3

4 / 4

4 / 4

4 / 4

4 / 2

4 / 2

ID_3

2 / 2

3 / 3

4 / 4

4 / 4

4 / 4

4 / 2

4 / 2

Topical

-

-

2 / 3

4 / 3

3 / 3

3 / 3

3 / 3

24

2

ID_1

0 / 1

3 / 3

4 / 4

4 / 4

4 / 4

4 / 3

4 / 3

ID_2

0 / 0

3 / 3

4 / 4

4 / 4

4 / 4

4 / 2

4 / 2

ID_3

2 / 2

3 / 3

4 / 4

4 / 4

4 / 4

4 / 2

4 / 2

Topical

-

-

3 / 3

4 / 3

3 / 3

3 / 3

3 / 3

25

2

ID_1

0 / 1

3 / 3

4 / 3

4 / 3

4 / 3

4 / 3

4 / 3

ID_2

2 / 0

3 / 3

4 / 4

4 / 3

4 / 4

4 / 2

4 / 2

ID_3

2 / 1

3 / 3

4 / 4

4 / 3

4 / 4

4 / 3

4 / 3

Topical

-

-

3 / 3

2 / 2

3 / 3

3 / 2

3 / 2

26

2

ID_1

0 / 1

3 / 3

4 / 4

4 / 4

4 / 4

4 / 3

4 / 3

ID_2

2 / 1

3 / 3

4 / 4

4 / 4

4 / 4

4 / 2

4 / 2

ID_3

2 / 1

3 / 3

4 / 4

4 / 4

4 / 4

4 / 2

4 / 3

Topical

-

-

3 / 3

4 / 3

3 / 3

3 / 2

3 / 2

27

2

ID_1

0 / 1

3 / 3

4 / 3

4 / 3

4 / 4

4 / 3

4 / 3

ID_2

0 / 0

3 / 3

4 / 4

4 / 3

4 / 4

4 / 2

4 / 2

ID_3

2 / 1

3 / 3

4 / 4

4 / 3

4 / 4

4 / 2

4 / 3

Topical

-

-

2 / 3

4 / 3

2 / 3

3 / 2

3 / 2

28

2

ID_1

0 / 1

3 / 3

4 / 4

4 / 4

4 / 4 

4 / 2

4 / 2

ID_2

0 / 0

3 / 3

4 / 4

4 / 4

4 / 4

4 / 2

4 / 2

ID_3

2 / 1

3 / 3

4 / 4

4 / 4

4 / 4

4 / 2

4 / 2

Topical

-

-

3 / 3

4 / 3

3 / 3

3 / 2

3 / 2

29

2

ID_1

0 / 1

3 / 2

4 / 4

4 / 4

4 / 4

4 / 3

4 / 3

ID_2

0 / 0

0 / 0

0 / 0

4 / 4

4 / 4

4 / 3

4 / 3

ID_3

2 / 1

3 / 2

4 / 4

4 / 4

4 / 4

4 / 3

4 / 3

Topical

-

-

3 / 3

4 / 3

3 / 3

3 / 3

3 / 3

30

2

ID_1

0 / 1

3 / 3

4 / 4

4 / 4

4 / 4

4 / 3

4 / 3

ID_2

0 / 0

3 / 3

4 / 4

4 / 4

4 / 4

4 / 2

4 / 2

ID_3

2 / 1

3 / 3

4 / 4

4 / 4

4 / 4

4 / 2

4 / 2

Topical

-

-

3 / 3

4 / 3

3 / 3

3 / 2

3 / 2

-: no observation was conducted

 

Table 3. Individual Sensitization Observation

Animal#

Group #

Score

24h

48h

16

1

1

1

17

1

1

1

18

1

0

1

19

1

1

1

20

1

1

1

21

2

1

1

22

2

1

1

23

2

1

1

24

2

1

1

25

2

1

1

26

2

1

1

27

2

0

1

28

2

1

0

29

2

1

1

30

2

1

1

Interpretation of results:
GHS criteria not met
Conclusions:
According to OECD 406 test method and “Magnusson and Kligman Maximization Grading”, the sensitization rate of CR SB32N2 was 0% and CR SB32N2 caused weak sensitization in guinea pigs. Therefore, CR SB32N2 was not met classification on GHS criteria.
Executive summary:

This test using the procedures outlined in the QPS Taiwan Study Plan for T65316014-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 CR SB32N2 show that test reliability criteria was met.

A 10% and 50% CR SB32N2 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 10% CR SB32N2. 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, no treated animals showed sensitization to the CR SB32N2. Under the conditions of this study, CR SB32N2 caused weak sensitization in guinea pigs.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A 10% and 50% CR SB32N2 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 10% CR SB32N2. 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, no treated animals showed sensitization to the CR SB32N2. Under the conditions of this study, CR SB32N2 caused weak sensitization in guinea pigs.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification