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
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Guideline:
other: Shelanski RIPT
GLP compliance:
not specified
Type of study:
other: human patch test
Species:
human
Vehicle:
other: butyl carbitol
Concentration / amount:
1%
Vehicle:
other: butyl carbitol
Concentration / amount:
1%
No. of animals per dose:
100
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
25 microliter 0% (vehicle control), 1%, 10%, 25%, 50%
No. of animals per dose:
5
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Reading:
other: no data
Group:
test group
Dose level:
1% in butyl carbitol
No. with + reactions:
0
Total no. in group:
100
Remarks on result:
other: Reading: other: no data. Group: test group. Dose level: 1% in butyl carbitol. No with. + reactions: 0.0. Total no. in groups: 100.0.
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)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The substance was found not to be a sensitizer in a cohort of 100 humans