Registration Dossier

Administrative data

Description of key information

The sensitization rate of Everdirect SH12 was 0% and Everdirect SH12 did not cause 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 22, 2015 to December 08, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Animal work was performed in Taiwan to meet regulatory requirements in Taiwan and China where in-vitro methods are not accepted
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: 373.4-397.0g
- Housing: Every five animals were housed in a stainless steel wire mesh cage
- Acclimation period: 7 days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 55 ± 15%
- Photoperiod: 12-hrs dark / 12-hrs light
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
0.1 mL and 0.5 mL of 6% Everdirect SH12 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:
0.5 mL of 6% Everdirect SH12
Day(s)/duration:
Day23
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
For control group: five
For test group: ten
Positive control substance(s):
yes
Remarks:
α-Hexylcinnamaldehyde (HCA)
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:
6%
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:
0%
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
Remarks on result:
not measured/tested
Remarks:
Not tested

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

481

385.7

487.1

+101.4

482

386.2

489.4

+103.2

483

393.4

500.9

+107.5

484

377.8

487.1

+109.3

485

390.2

492.0

+101.8

Test group

Male

486

381.5

488.3

+106.8

487

373.4

478.8

+105.4

488

382.3

485.1

+102.8

489

391.5

492.0

+100.5

490

395.6

500.2

+104.6

491

396.7

495.9

+99.2

492

386.2

482.7

+96.5

493

373.4

470.7

+97.3

494

395.8

501.2

+105.4

495

397.0

496.3

+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

481

0

0

0%

Weak

482

0

0

483

0

0

484

0

0

485

0

0

Test group

Male

486

0

0

0%

Weak

487

0

0

488

0

0

489

0

0

490

0

0

491

0

0

492

0

0

493

0

0

494

0

0

495

0

0

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

2 The 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 Everdirect SH12 was 0% and Everdirect SH12 caused weak sensitization in guinea pigs. Therefore, Everdirect SH12 was not met a category based on GHS criteria.
Executive summary:

This test using the procedures outlined in the SuperLab Study Plan for M62-151100082001EN 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 Everdirect SH12 show that test reliability criteria was met.

A 6% Everdirect SH12 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 6% Everdirect SH12. 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 Everdirect SH12. Under the conditions of this study, Everdirect SH12 did not caused any sensitization in guinea pigs.

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

Skin sensitization

A 6% Everdirect SH12 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 6% Everdirect SH12. 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 Everdirect SH12. Under the conditions of this study, Everdirect SH12 did not caused any sensitization in guinea pigs.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification