Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Publication in Japanese, no details available

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
The environment of the skin
Author:
Ishihara M
Year:
1978
Bibliographic source:
Journal of the Medical Society of Toho University, Japan 25(5/6), 750-765
Reference Type:
publication
Title:
Some problems with patch tests using fragrance materials
Author:
Ishihara M, Itoh M, Hosono K
Year:
1978
Bibliographic source:
Skin Research 23(6), 806-817

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The substance was applied to human skin with patches at concentrations of 2% and 5%.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-phenylbutan-2-one
EC Number:
219-847-4
EC Name:
4-phenylbutan-2-one
Cas Number:
2550-26-7
Molecular formula:
C10H12O
IUPAC Name:
4-phenylbutan-2-one

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
no data
Clinical history:
no data
Route of administration:
dermal

Results and discussion

Results of examinations:
No preexisting skin sensitization was observed in dermatologic patients.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 41
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

Applicant's summary and conclusion

Conclusions:
The substance was not sensitising to human skin in a patch test.
Executive summary:

The substance was not sensitising to human skin in vivo at concentrations of 2% and 5%.