Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted comparable to EU Guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
1992
Deviations:
yes
Remarks:
No positive control animals were used, different vehicles were used for induction and challenge exposure.
GLP compliance:
no
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: granular solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Redfern Animal Breeders, Brenchley, Kent
- Age at study initiation: young
- Weight at study initiation: 300-400 g

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: epicutaneous
Vehicle:
other: induction: aqueous ethanol, challenge: acetone
Concentration / amount:
concentration used for induction: 0.1 % w/v in aqueous ethanol
concentration used for challenge applications: 0.1 % w/v in acetone
Challengeopen allclose all
Route:
other: epicutaneous
Vehicle:
other: induction: aqueous ethanol, challenge: acetone
Concentration / amount:
concentration used for induction: 0.1 % w/v in aqueous ethanol
concentration used for challenge applications: 0.1 % w/v in acetone
No. of animals per dose:
20 (10 male and 10 female)
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 14 days
- Test groups: 20 animals
- Control group: 10 animals
- Frequency of applications: weekly intervals
- Duration: 6 hours
- Concentrations: 0.1 % (w/v)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after last induction application (on Day 28)
- Exposure period: one application (6 h duration)
- Concentrations: 0.1 % (w/v)
- Evaluation (hr after challenge): 24 and 48

Challenge controls:
no data
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.1 % (w/v)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 % (w/v). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.1 % (w/v)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1 % (w/v). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.

Applicant's summary and conclusion