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 (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA
Vehicle:
acetone/olive oil (4:1 v/v)
No. of animals per dose:
5
Parameter:
SI
Remarks on result:
other: see Remark
Remarks:
Each of the three tested concentrations of the test item exceeded the stimulation index of3. The stimulation index at a concentration of 6.25% was 3.3 The stimulation index at a concentration of 12.5% was 3.8 The stimulation index at a concentration of 25% was 3.6 The mean ear thickness on day 1 day 3 day 6 for the 6.25% test group was 0.18 mm 0.18 mm 0.18 mm for the 12.5% test group was 0.18 mm 0.19 mm 0.19 mm for the 25% test group was 0.18 mm 0.18 mm 0.19 mm for the negative control group was 0.18 mm 0.18 mm 0.18 mm
Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Justification for classification or non-classification