Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
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:
female
Details on test animals and environmental conditions:
Hartley strain albino

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: liquid paraffin (intradermal induction); see also under concentration (next box)
Concentration / amount:
Intradermal induction: 0.1 ml of the test formulation (a. 10w/w%; b. 1:1 emulsion of 20w/w% test formulation (test article mixed with FCA) and saline; c. 100% test item)
Topical induction: 0.2 ml of the test formulation (a. 10w/w%; b. 1:1 emulsion of 20w/w% test formulation (test article mixed with FCA) and saline; c. 100% test item) --> exposure for 48 hrs
Challenge: a. 0.1 ml of the test formulations at two concentrations (100% and 50 w/w% in polyethylene glycol 300) --> exposure for 24 hrs

Intradermal dosing: Day 1
Induction dosing: Day 1 + 6
Challenge dosing: Day 1 + 20
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: liquid paraffin (intradermal induction); see also under concentration (next box)
Concentration / amount:
Intradermal induction: 0.1 ml of the test formulation (a. 10w/w%; b. 1:1 emulsion of 20w/w% test formulation (test article mixed with FCA) and saline; c. 100% test item)
Topical induction: 0.2 ml of the test formulation (a. 10w/w%; b. 1:1 emulsion of 20w/w% test formulation (test article mixed with FCA) and saline; c. 100% test item) --> exposure for 48 hrs
Challenge: a. 0.1 ml of the test formulations at two concentrations (100% and 50 w/w% in polyethylene glycol 300) --> exposure for 24 hrs

Intradermal dosing: Day 1
Induction dosing: Day 1 + 6
Challenge dosing: Day 1 + 20
No. of animals per dose:
5 (control group) and 10 (test item sensitization group)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100% and 50 w/w%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no abnormal clinical signs in any animal in any group
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100% and 50 w/w%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no abnormal clinical signs in any animal in any group.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100% and 50 w/w-%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no abnormal clinical signs in any animal in any group
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100% and 50 w/w-%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no abnormal clinical signs in any animal in any group.
Reading:
1st reading
Hours after challenge:
24
Group:
other: control group
Dose level:
100% and 50 w/w-%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no abnormal clinical signs in any animal in any group
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group:
Reading:
2nd reading
Hours after challenge:
48
Group:
other: control group
Dose level:
100% and 50 w/w-%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no abnormal clinical signs in any animal in any group
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group:

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test item was judged to have no sensitization potential.