Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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