Registration Dossier

Diss Factsheets

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:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: secondary source
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Route:
intradermal and epicutaneous
Vehicle:
other: acetone (for challenge)
Concentration / amount:
Induction:
Induction Concentration: 5%, 2.5%, 1.0% and 0.5%
Intradermal injection: 2.5%
Topical:100%

Challenge
2.5, 50, 75 and 100 mg moistened with acetone
Route:
other: epicutaneous, not specified
Vehicle:
other: acetone (for challenge)
Concentration / amount:
Induction:
Induction Concentration: 5%, 2.5%, 1.0% and 0.5%
Intradermal injection: 2.5%
Topical:100%

Challenge
2.5, 50, 75 and 100 mg moistened with acetone
No. of animals per dose:
20 (test group)
10 (control group)
Details on study design:
For the topical induction phase, the skin was treated with sodium lauryl sulfate
Challenge controls:
no
Positive control substance(s):
yes
Remarks:
α-Hexylcinnamaldehyde
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100mg
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: 100mg. No with. + reactions: 0.0. Total no. in groups: 20.0.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
Information is available from the full public report issued by the Australian competent authority (NICNAS); it is therefore assumed to provide reliable information.

Justification for classification or non-classification