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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From December 1, 2015 to October 11, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
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.

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of diazotised Benzenesulfonic acid, 2-amino-5-[[2-(sulfooxy)ethyl]sulfonyl]-, subsequently coupled with Urea, N-(3-aminophenyl)-, subsequently condensation with 1,3,5-Triazine, 2,4,6-trichloro-, further condensation with Benzenesulfonic acid, 3-amino- and 3-Pyridinecarboxylic acid, sodium salts
EC Number:
944-617-1
Molecular formula:
C8H11NO9S3 . C7H9N3O . C3Cl3N3 . C6H7NO3S . C6H5NO2 . Na
IUPAC Name:
Reaction products of diazotised Benzenesulfonic acid, 2-amino-5-[[2-(sulfooxy)ethyl]sulfonyl]-, subsequently coupled with Urea, N-(3-aminophenyl)-, subsequently condensation with 1,3,5-Triazine, 2,4,6-trichloro-, further condensation with Benzenesulfonic acid, 3-amino- and 3-Pyridinecarboxylic acid, sodium salts
Test material form:
solid: particulate/powder

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
- Source: WEI XIN HANG
- Weight at study initiation: 367.3-388.4 g
- 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

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
0.1 mL and 0.5 mL of 10% CR SB07 for intradermal and epicutaneous, respectively
Day(s)/duration:
Day 1 and Day 7 for intradermal and epicutaneous, respectively
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
Challenge
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
0.5 mL of 10% CR SB07
Day(s)/duration:
Day 23
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)

Results and discussion

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%.

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10 % of CR SB07
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

Any other information on results incl. tables

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

451

369.3

474.3

+ 105.0

452

374.3

473.7

+ 99.4

453

369.3

471.0

+ 101.7

454

380.4

483.6

+ 103.2

455

370.6

470.6

+ 100.0

Test group

Male

456

379.6

478.2

+ 98.6

457

372.6

475.7

+ 103.1

458

367.3

466.0

+ 98.7

459

385.6

488.2

+ 102.6

460

375.8

482.3

+ 106.5

461

382.1

480.3

+ 98.2

462

377.2

476.7

+ 99.5

463

386.4

492.0

+ 105.6

464

388.4

491.4

+ 103.0

465

387.2

498.7

+ 111.5

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

451

0

0

0%

Weak

452

0

0

453

0

0

454

0

0

455

0

0

Test group

Male

456

0

0

0%

Weak

457

0

0

458

0

0

459

0

0

460

0

0

461

0

0

462

0

0

463

0

0

464

0

0

465

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”.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to OECD 406 test method and “Scoring system of Kligman”, the sensitization rate of CR SB07 was 0% and CR SB07 caused weak sensitization in guinea pigs. Therefore, CR SB07 was not met a category based on GHS criteria.
Executive summary:

This test using the procedures outlined in the SuperLab Study Plan for M62-151100054001EN 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 SB07 show that test reliability criteria was met.

A 10% CR SB07 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 SB07. 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 SB07. Under the conditions of this study, CR SB07 did not caused any sensitization in guinea pigs.

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