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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:
1998-04-15 to 1998-06-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
predates LLNA method

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium methyl sulphate
EC Number:
258-946-7
EC Name:
2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium methyl sulphate
Cas Number:
54060-92-3
Molecular formula:
C20H24N3O.CH3O4S C21H27N3O5S
IUPAC Name:
2-{[2-(4-methoxyphenyl)-2-methylhydrazin-1-ylidene]methyl}-1,3,3-trimethyl-3H-indol-1-ium methyl sulfate
Test material form:
solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: pirbright-white
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, Gartenstraße 27, 33178 Borchen, Germany
- Age at study initiation: -
- Weight at study initiation: 339 g to 414 g
- Housing: 5 animals/group in type 4 macrolon cages
- Diet (ad libitum): ssniff Ms-H V2233, ad libitum
- Water (ad libitum): tap water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1998-04-15 to 1998-05-22

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Induction and Challenge: 0.5 g test substance moistened with 0.5 mL deionized water
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Induction and Challenge: 0.5 g test substance moistened with 0.5 mL deionized water
No. of animals per dose:
Determination of primary non-irritant concentration: 3
Control group: 10
Treatment group: 20
Details on study design:
RANGE FINDING TESTS:
100 %, 20 %, 4 % (1000, 200, 40 mg/mL)

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours occlusive
- Test groups: 0.5 g test substance moistened with 0.5 mL deionized water
- Control group: 0.5 mL deionized water
- Frequency of applications: once/week
- Duration: Day 1 to 15
- Site: left flank
- Concentrations: 100 %

Days 16 to 28
No further animal treatment.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: starting on Day 29
- Exposure period: 6 hours occlusive
- Test groups: 0.5 g test substance moistened with 0.5 mL deionized water
- Control group: 0.5 g test substance moistened with 0.5 mL deionized water
- Site: right flank
- Concentrations: 100 %
- Evaluation (hr after challenge): 24 hours (day 30) and 48 hours (day 31) after removal of patches

OTHER:
- body weights and clinical signs were recorded
Challenge controls:
NA
Positive control substance(s):
yes
Remarks:
alpha-hexyl cinnamic aldehyde in PEG 400

Results and discussion

Positive control results:
After the second challenge treatment 6 animals of the treatment groupm (30%) showed a positive reaction.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1000 mg/mL
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
skin surface orange discolored
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1000 mg/mL. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: skin surface orange discolored.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1000 mg/mL
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
skin surface orange discolored
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1000 mg/mL. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: skin surface orange discolored.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1000 mg/mL
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
skin surface orange discolored
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1000 mg/mL. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: skin surface orange discolored.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1000 mg/mL
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
skin surface orange discolored
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1000 mg/mL. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: skin surface orange discolored.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
20 %
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 20 %. No with. + reactions: 2.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
20 %
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 20 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
positive control
Dose level:
20 %
No. with + reactions:
6
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: positive control. Dose level: 20 %. No with. + reactions: 6.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
positive control
Dose level:
20 %
No. with + reactions:
5
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: positive control. Dose level: 20 %. No with. + reactions: 5.0. Total no. in groups: 20.0.

Any other information on results incl. tables

Body weight gains and clinical signs:

The body weight gains of the animals were not impaired. Moreover, the treated animals showed no clinical signs of intoxication throughout the study.

Irritations during the sensitization phase:

No signs of irritation occurred during the observation period. The skin surface of the treatment group was discolored orange.

Dermal challenge treatment:

No positive skin response was observed in the control and the treatment group 24 and 48 hours after removal of the occlusive bandage. The skin-surface of the animals was discolored orange.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item showed no sensitizing properties in the Buehler test.
Executive summary:

In a dermal sensitization study (OECD 406) with the test item 20 female Pirbright-White guinea pigs were tested using the method of Buehler. Dermal induction was performed using 0.5 g of the test item moistened with 0.5 mL deionized water. Challenge of the treatment and control group were carried out with 0.5 g of the test item moistened with 0.5 mL deionized water. Under the conditions of the present study, none of the twenty treated guinea pigs showed a positive skin response 24 hours and 48 hours after the challenge procedure. Thus, the test item is not a dermal sensitizer.

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