Registration Dossier

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Title:
Final report on the safety assessment of benzophenones-1, -3, -4, -5, -9, and -11
Author:
Anonymous
Year:
1983
Bibliographic source:
Journal of the American College of Toxicology, Volume 2, Number 5 (1983), page 35-77

Materials and methods

Test guideline
Guideline:
other: Shelanski RIPT
GLP compliance:
not specified
Type of study:
other: human patch test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
human

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Vehicle:
other: butyl carbitol
Concentration / amount:
1%
Challengeopen allclose all
Vehicle:
other: butyl carbitol
Concentration / amount:
1%
No. of animals per dose:
100

Study design: in vivo (LLNA)

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)

Results and discussion

In vivo (non-LLNA)

Results
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.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU