Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: data from secondary source with limited documentation

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Appraisal of sensitizing powers by maximization testing in humans
Author:
Kligman A.M.
Year:
1971
Bibliographic source:
cited in the RIFM/FEMA Database, Location 1805
Reference Type:
secondary source
Title:
Fragrance raw materials monographs: citronellyl acetate
Author:
Kligman
Year:
1973
Bibliographic source:
cited in: Food Cosmet. Toxicol., 11, 1973, 1069

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Human maximization test
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Citronellyl acetate
EC Number:
205-775-0
EC Name:
Citronellyl acetate
Cas Number:
150-84-5
Molecular formula:
C12H22O2
IUPAC Name:
3,7-dimethyloct-6-en-1-yl acetate
Test material form:
not specified
Details on test material:
No additional details provided.

Method

Type of population:
not specified
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 25
- Sex: male
Route of administration:
dermal
Details on study design:
ADMINISTRATION
- Type of application: occlusive
- Vehicle / solvent: petrolatum
- Concentrations: 4%
- Testing schedule: 5 alternate-day 48 h periods; then 10 d rest period; challenge for 48 h on fresh site; evaluation after patch removal and 24 h thereafter

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: no effects observed

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0/25
- Number of subjects with negative reactions: 25/25
- Number of subjects with equivocal reactions: 0/25
- Number of subjects with irritating reactions: 0/25

Applicant's summary and conclusion