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Toxicological information

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
An in vivo test for skin sensitisation according to OECD Guidance 406 (guinea pig maximisation test) is already available. Thus, the informtion requirement is fulfilled, and for animal welfare reasons, another in vivo test is not conducted.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White (Bor: DAPW)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann /Borchen
- Age at study initiation: 9 weeks
- Weight at study initiation: males: 410-473 g; females 375-421 g
- Housing: individually, Macrolon cages Type III
- Diet (e.g. ad libitum): ssniff (G) ad libitum
- Water (e.g. ad libitum): tap water ad libitum (twice weekly + vitamin C)
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS: according to guideline

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
peanut oil
Concentration / amount:
1st application: Induction with 0.1 mL of a 3 % (w/w) solution in peanut oil, intradermal
2nd application: Induction with 0.7 mL undiluted test substance (30-35°C), occlusive epicutaneous (pretreatment of skin with 10 % SDS solution)
3rd application: Challenge with 0.2 mL undiluted test substance (30-35°C), occlusive epicutaneous
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
peanut oil
Concentration / amount:
1st application: Induction with 0.1 mL of a 3 % (w/w) solution in peanut oil, intradermal
2nd application: Induction with 0.7 mL undiluted test substance (30-35°C), occlusive epicutaneous (pretreatment of skin with 10 % SDS solution)
3rd application: Challenge with 0.2 mL undiluted test substance (30-35°C), occlusive epicutaneous
No. of animals per dose:
control group: 10 animals
treatment group: 10 animals
Details on study design:
RANGE FINDING TESTS: In preliminary tests, the maximum non-irritating concentration for the intradermal or the slight to moderate irritating concentration for the epidermal application during the induction phase as well as a non-irritating concentration for the epidermal application during the challenge phase were determined

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: day 1 intradermal and day 8 epicutaneous for 48 h
- Test groups: 1 with 10 animals
- Control group: 1 with 10 animals
- Site: intradermal - scapular region three pairs of intradermal injections in two parallel lines; epicutaneous - same region was covered with a patch
- Frequency of applications:
- Duration:
- Concentrations: treatment group: intradermal: pair one: FCA/ saline solution 1:1
pair two: test substance solution (3% (w/w) in peanut oil)
pair three: test substance solution / FCA 1:1
epicutaneous: undiluted (30-35°C)
control group: vehicle instead of tets substance



B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 22
- Exposure period: 24 h
- Test groups: occlusive patch with 0.2 mL undiluted test substance (30-35°C)
- Control group: identical to treatment group (right flank treated with vehicle alone in both groups)
- Site: right flank (vehicle), left flank (test substance)
- Concentrations: 0.2 mL undiluted test substance
- Evaluation (hr after challenge): 24 and 48 h after challenge
Positive control substance(s):
yes
Remarks:
para-phenylenediamine

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.2 mL undiluted test substance (30-35°C)
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
slight erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.2 mL undiluted test substance (30-35°C). No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: slight erythema .
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.2 mL undiluted test substance (30-35°C)
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
slight erythema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.2 mL undiluted test substance (30-35°C). No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: slight erythema.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.2 mL undiluted test substance (30-35°C)
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.2 mL undiluted test substance (30-35°C). No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.2 mL undiluted test substance (30-35°C)
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.2 mL undiluted test substance (30-35°C). No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

1 of 10 animals exhibited a slight erythema at the treated site 24 and 48 hours after removal of the patch. None of the animals of the control group showed changes at the exposed skin areas. Systemic toxic effects could not be detected. The general condition and body weight development of the test animals were not affected.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Classification: not sensitizing