Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
olive oil
Concentration / amount:
intradermal: 1% in olive oil
epicutaneous: 6% in vaseline after irritating with lauryl sulfate
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
intradermal: 1% in olive oil
epicutaneous: 6% in vaseline after irritating with lauryl sulfate
No. of animals per dose:
20
Positive control substance(s):
yes
Remarks:
Kaptax, EC n°205-736-8

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
6%
No. with + reactions:
9
Total no. in group:
20
Clinical observations:
light erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 6%. No with. + reactions: 9.0. Total no. in groups: 20.0. Clinical observations: light erythema.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
3%
No. with + reactions:
7
Total no. in group:
20
Clinical observations:
light erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3%. No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: light erythema.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no reaction
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no reaction.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
6%
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
light erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 6%. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: light erythema.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
3%
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
light erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 3%. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: light erythema.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no reaction
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no reaction.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
6%
No. with + reactions:
7
Total no. in group:
20
Clinical observations:
light erythema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 6%. No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: light erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
3%
No. with + reactions:
6
Total no. in group:
20
Clinical observations:
light erythema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3%. No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: light erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no reaction
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no reaction.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
6%
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
light erythema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 6%. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: light erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
3%
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
light erythema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 3%. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: light erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no reaction
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no reaction.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test group
Dose level:
6%
No. with + reactions:
6
Total no. in group:
20
Clinical observations:
3 animals with desquamation
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 6%. No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: 3 animals with desquamation.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test group
Dose level:
3%
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
1 animal with desquamation
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 3%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: 1 animal with desquamation.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test group
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no reaction
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no reaction.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
6%
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
light erythema
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 6%. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: light erythema.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
3%
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
light erythema
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 3%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: light erythema.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no reaction
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no reaction.
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
2%
No. with + reactions:
7
Total no. in group:
20
Clinical observations:
light erythema
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 2%. No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: light erythema.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
2%
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
light erythema
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 2%. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: light erythema.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU