Registration Dossier

Diss Factsheets

Toxicological information

Exposure related observations in humans: other data

Currently viewing:

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Article in foreign language (Japanese). Basic information obtained from the english translated summary and tables.

Data source

Reference
Reference Type:
publication
Title:
Studies on Compoxinded Perfumes for Toilet Goods. On the Non-irritative Compounded Perfumes for Soaps
Author:
Tetsuya Fujii , Saburö Furukawa and Seiji Suzuki
Year:
1972
Bibliographic source:
Yukugaku 21(12), 904-908

Materials and methods

Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Two different closed patch test were conducted on healthy male and female subjects. For the first closed patch test, the small of back of 34 subjects were treated with 20% test substance in vaselinum aldum or unguentum hydrophilicum for 48 hours. In the second closed patch test, 2% test substance was applied on the upper inside of arm of 30 subjects for 24-72 hours. Unguentum simplex and unguentum hydrophilicum served as vehicle.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzyl propionate
EC Number:
204-559-3
EC Name:
Benzyl propionate
Cas Number:
122-63-4
Molecular formula:
C10H12O2
IUPAC Name:
benzyl propanoate

Method

Ethical approval:
not specified
Details on study design:
- 34 humans (first test) and 30 humans (second test)
- SCORING SYSTEM:
Reactions were recorded according to the following criteria: (-) = No reaction [negative reaction]; (+/- ) = Slight Erythema [suspected positive reaction]; (+) = Erythema [positive reaction]; (++) = Erythema and Dropsical swelling [positive reaction]; (+++) = Erythema, Papules and Vesicles [positive reaction].
Details on exposure:
TYPE OF EXPOSURE: closed

EXPOSURE LEVELS: 20% or 2%

EXPOSURE PERIOD: 24-72 hours (first test), 48 hours (second test)

Results and discussion

Results:
No reactions (erythema) were observed at 20% and 2% of the test substance.

Applicant's summary and conclusion

Conclusions:
No irritant reactions were produced neither at concentration of 20% test substance nor at a dose of 2% test substance.
Executive summary:

The publication described two closed patch tests which were conducted on healthy male and female subjects. For the 48 hour closed patch test, 34 subjects were treated with 20% test substance in vaselinum aldum or unguentum hydrophilicum on the small back. In addition, a 24- to 72 -hour closed patch test was conducted on 30 male and female subjects, with the test item at 2% in unguentum simplex or unguentum hydrophilicum. In both tests, no irritant reactions were produced in the subjects.