Registration Dossier

Administrative data

Description of key information

The sensitization rate of CR SB08 was 0% and CR SB08 did not caused any 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 09, 2015 to June 27, 2016
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:
male
Details on test animals and environmental conditions:
- Source: WEI XIN HANG
- Weight at study initiation: 352.1-379.6g
- Housing: Every five 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:
physiological saline
Concentration / amount:
0.1mL and 0.5mL of 10% CR SB08 for intradermal and epicutaneous, respectively
Day(s)/duration:
Day1 and Day7 for intradermal and epicutaneous, respectively
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
0.5mL of 10% CR SB08
Day(s)/duration:
Day23
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Control group: five
Test group: ten
Positive control substance(s):
yes
Remarks:
α-Hexylcinnamaldehyde
Positive control results:
The latest results showed that positive control animals had shown skin reactions of 1-2 and the sensitization rate of α-Hexylcinnamaldehyde (HCA) was 100%.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
0.5 mL of 10% CR SB08
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
There was no emergence of erythema and edema on the skin of the observation period
Remarks on result:
no indication of skin sensitisation

Table 1. The body weight of the guinea pigs

Group

Sex

Animal ID.

Animal Weight (g)

Weight Change

(g)

Day 1

Day 26

Control group

Male

466

369.5

468.2

+98.7

467

376.4

478.6

+102.2

468

359.2

460.9

+101.7

469

368.0

470.1

+102.1

470

375.4

474.8

+99.4

Test group

Male

471

373.1

477.6

+104.5

472

359.3

461.5

+102.2

473

367.2

471.0

+103.8

474

364.1

463.9

+99.8

475

357.2

457.2

+100.0

476

377.6

483.5

+105.9

477

379.6

480.5

+100.9

478

354.2

459.9

+105.7

479

363.7

467.3

+103.6

480

352.1

451.4

+99.3

Table 2. Individual skin reaction of guinea pigs

Group

Sex

Animal ID.

Grade of skin reaction1

Percent of Animals Sensitized

Sensitizing Capacity2

24 ± 1 hrs

48 ± 1 hrs

Control group

Male

466

0

0

0%

Weak

467

0

0

468

0

0

469

0

0

470

0

0

Test group

Male

471

0

0

0%

Weak

472

0

0

473

0

0

474

0

0

475

0

0

476

0

0

477

0

0

478

0

0

479

0

0

480

0

0

1The skin reaction was grading according to “Magnusson and Kligman scale”.

2The sensitizing capacity of the test article was classified according to the “Scoring system of Kligman”.

Interpretation of results:
GHS criteria not met
Conclusions:
According to OECD 406 test method and “Scoring system of Kligman”, the sensitization rate of CR SB08 was 0% and CR SB08 caused weak sensitization in guinea pigs. Therefore, CR SB08 was not met a category based on GHS criteria.
Executive summary:

This test using the procedures outlined in the SuperLab Study Plan for M62-151100070001EN which is based on the SOP for the OECD 406 (SOPP-339) and OECD 406 (OECD, 1992). The results of this OECD 406 test for CR SB08 show that test reliability criteria was met.

A 10% CR SB08 was used for intradermal injection and occlusively patched, to ten test guinea pigs to induce sensitization. The normal saline 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 SB08. 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, 0% treated animals showed sensitization to the CR SB08. Under the conditions of this study,CR SB08 did not caused any sensitization in guinea pigs.

 

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

Skin sensitization

A 10% CR SB08 was used for intradermal injection and occlusively patched, to ten test guinea pigs to induce sensitization. The normal saline 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 SB08. 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, 0% treated animals showed sensitization to the CR SB08. Under the conditions of this study,CR SB08 did not caused any sensitization in guinea pigs.

Justification for classification or non-classification