Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
non-LLNA method experimental result was already available
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
1st: Induction .1 % intracutaneous
2nd: Induction 3 % occlusive epicutaneous
3rd: Challenge 1 % occlusive epicutaneous
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
1st: Induction .1 % intracutaneous
2nd: Induction 3 % occlusive epicutaneous
3rd: Challenge 1 % occlusive epicutaneous
No. of animals per dose:
20 animals for test
10 animals for control
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 20.0.

RESULTS OF TEST - Sensitization reaction: 0/20 animals positive at 24 hours and at 48 hours = no sensitization no animals positive in control group - Clinical signs: 1st induction, FCA application sites: severe erythema and edema, slight to severe necroses 1st induction, vehicle + test substance application sites: distinct erythema and edema 1st induction, vehicle application sites: slight erythema 2nd induction, test and control groups: some FCA injection sites bleeding, wounds from scratching; crust formation within 24 hours - Other: Mean body weight gain 124.8 g in test group, 120.1 g in control group = expected range

Interpretation of results:
not sensitising
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification

According to the available study the substance is not sensitising