Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Hsd Poc:DH
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: intradermal and topical
Vehicle:
polyethylene glycol
Concentration / amount:
Intradermal induction: 5 % in PEG 400
Topical induction: 100 %
1. Challenge: 12 % in PEG 400
2. Challenge: 6 % in PEG 400
Challenge
Concentration / amount:
Intradermal induction: 5 % in PEG 400
Topical induction: 100 %
1. Challenge: 12 % in PEG 400
2. Challenge: 6 % in PEG 400
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 10

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
12%
No. with + reactions:
9
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 12%. No with. + reactions: 9.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
12 %
No. with + reactions:
10
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 12 %. No with. + reactions: 10.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
24
Group:
test group
Dose level:
6 %
No. with + reactions:
11
Total no. in group:
18
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 6 %. No with. + reactions: 11.0. Total no. in groups: 18.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
6 %
No. with + reactions:
8
Total no. in group:
18
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 6 %. No with. + reactions: 8.0. Total no. in groups: 18.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
12 %
No. with + reactions:
3
Total no. in group:
9
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 12 %. No with. + reactions: 3.0. Total no. in groups: 9.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
6 %
No. with + reactions:
0
Total no. in group:
9
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 6 %. No with. + reactions: 0.0. Total no. in groups: 9.0.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU