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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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