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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Published unavailable after INIST request

Data source

Reference
Reference Type:
publication
Title:
Fundamental studies of safe compound perfumes for cosmetics. Part 1. The primary irritation of compound materials to the skin
Author:
Takenaka T. , Hasegawa E. , Takenaka U. , Saito F. and Odaka T.
Year:
1986
Bibliographic source:
Unknown Source, pp. 313-329.

Materials and methods

Type of sensitisation studied:
skin
Study type:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

Method

Type of population:
not specified
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 4737 (30-200 patients each time)
- Sex: men/women
- Age: 16+ years
- Race: Japanese
- Demographic information: no data
- Other: The period of study extended over 4 yrs and 3 months and patch testing was performed 1-3 times per month; September to May (summer months were excluded). The total number of subjects was 4737 (2341 Japanese men and 2396 Japanese women aged 16-45, mostly 17-30, living in Tokyo and Osaka). Volume dose not provided
Clinical history:
no data
Controls:
no data
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: Patches consisted of a piece of 1 cm2 lint with a 2 cm2 cellophane disc placed on the lint and then covered with 4 cm2 plaster
- Vehicle / solvent: a base cream or 99% ethanol
- Concentrations: 0.05-0.5%
- Volume applied: no data
- Testing/scoring schedule: application for 24 or 48 h
- Removal of test substance: no data
- Other: /

EXAMINATIONS (important)
- Grading/Scoring system: The skin reaction was graded as follows: - No visible reaction; +- Slight erythema; + Erythema; ++ Erythema and swelling or marked erythema.

Results and discussion

Results of examinations:
Not sensitizing, no more information.

Applicant's summary and conclusion

Conclusions:
Patch test of the substance at concentration of 0.05 to 0.5% did not show any skin sensitization reaction in human.