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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 July 2015 - 19 August 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
A valid Bühler test is avalaible, therefore no further LLNA is required.

Test material

Constituent 1
Chemical structure
Reference substance name:
Chromate(1-), bis[4-[[4-(ethylsulfonyl)-2-hydroxyphenyl]azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]-, compd. with 1,6-hexanediamine (2:1)
EC Number:
310-133-9
EC Name:
Chromate(1-), bis[4-[[4-(ethylsulfonyl)-2-hydroxyphenyl]azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]-, compd. with 1,6-hexanediamine (2:1)
Cas Number:
69997-91-7
Molecular formula:
C36H32CrN8O8S2.1/2C6H16N2.H
IUPAC Name:
Chromate(1-), bis[4-[[4-(ethylsulfonyl)-2-hydroxyphenyl]azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]-, compd. with 1,6-hexanediamine (2:1)
Details on test material:
- Physical state: Solid / red
- Storage condition of test material: Room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HARLAN (Kreuzelweg 53, 5961 NM HORST The Netherlands)
- Age at study initiation: 3 or 4 weeks
- Weight at study initiation: ca 273g (average)
- Housing: in groups of 2 in polycarbonate containers
- Diet: SAFE 106, ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
40%
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
40%
No. of animals per dose:
20 in test group and 10 in control group
Details on study design:
RANGE FINDING TESTS:
Three guinea pigs were treated with the test item placed onto the selected treatment sites and covered with an occlusive dressing for a period of 6 hours at 4 different concentrations: diluted at 40%, 30%, 20% and 10% in propylene glycol. The animals treated at the concentrations of 40%, 30%, 20% and 10% received 0.5 mL of the corresponding preparation. Washing of the skin after removal of the dressing was done with propylene glycol. A macroscopic evaluation of the cutaneous reactions was conducted 24 and 48 hours after removal of the occlusive dressings. The skin reaction was observed and recorded. 24 and 48 hours after removal of the patches, no cutaneous reaction was noted at all tested concentrations. In view of these results, the concentration selected was 40% for the 3 inductions of the main study and the concentration selected was 40% for the challenge phase.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: three applications, on day 0, day 6 and day 13
- Test groups: 20 females
- Control group: 10 females, 0.5 mL of propylene glycol
- Site: scapular zone
- Duration: 6 hours
- Concentrations: 40%

B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: 14 days after the last induction
- Exposure duration: 6 hours
- Test groups: 0.5 mL of the test item at 40% in propylene glycol on the left flank and 0.5 mL of propylene glycol on the right flank
- Control group: 0.5 mL of the test item at 40% in propylene glycol on the left flank and 0.5 mL of propylene glycol on the right flank
- Site: dorso-lumbar zone, on either side of the spine
- Concentrations: 40%
- Evaluation (hr after challenge): 24 and 48 hours after removal of the occlusive dressing
Positive control substance(s):
yes
Remarks:
The results of the 3 last positive groups (Reference substance: a-Hexylcinnamaldehyde CAS n° 101-86-0 - Tests n°17-19) carried out as method sensibility, are presented in the report.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
40%
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
40%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
40%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
40%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10

Any other information on results incl. tables

- Induction phase

No cutaneous reaction was recorded during the induction phase in the treated group. Red discoloration of the application area was noted after patch removal, but the staining did not prevent the assessment of erythema. No cutaneous reaction was recorded during the induction phase in the control group.

- Challenge phase:

In the treatment group (treatment concentration of 40%), no macroscopic cutaneous reactions attributable to allergy were observed during the examination following the removal of the occlusive dressing. Red discoloration of the application area was noted after patch removal, but the staining did not prevent the assessment of erythema. In the control group (associated with the treatment concentration of 40%), no cutaneous intolerance reaction was observed during the examination following the removal of the occlusive dressing. No cutaneous reaction was recorded in animals from the treated and control groups after the challenge phase, on the treated area with propylene glycol.

- Weight evolution

No abnormalities and no differences in the body weight between the control and the treated group were observed.

- Mortality

No mortality was registered during the main test.

- Clinical signs

No abnormal clinical signs related to the administration of the test item were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In view of these results, under these experimental conditions, the test item is not a skin sensitiser.
Executive summary:

The aim of the study was to evaluate the possible allergenic activity of the test item after topical administration in guinea pigs. The induction phase was conducted with three topical applications of the test item diluted at 40% (w/w) in propylene glycol to 20 guinea-pigs with occlusive dressing and a 13-day rest phase. The challenge phase, conducted under an occlusive dressing for 6 hours, consisted of a single topical application of the test item at 40% and an application of a negative control (propylene glycol). The concentration selected for the induction phase and the challenge based on the result of a pre-test. Readings were performed 24 and 48 hours after removal of the patches. In the treatment group (treatment concentration of 40%), no macroscopic cutaneous reactions attributable to allergy were observed during the examination following the removal of the occlusive dressing. In the control group (associated with the treatment concentration of 40%), no cutaneous intolerance reaction was observed during the examination following the removal of the occlusive dressing. No cutaneous reaction was recorded in animals from the treated and control groups after the challenge phase, on the treated area with propylene glycol. In conclusion, in view of these results, under these experimental conditions, the test item is not a skin sensitiser.