Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Cited as secondary source in a peer reviewed journal. Basic data given.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Appraisal of sensitizing powers by maximization testing in humans
Author:
Kligman AM
Year:
1971
Bibliographic source:
Report to RIFM, cited in Opdyke DLJ, Food Cosmet. Toxicol., Fragrance Raw Materials Monographs, Vol. 12: 239, 1974
Reference Type:
secondary source
Title:
Appraisal of sensitizing powers by maximization testing in humans. Report to RIFM
Author:
A.M.Kligman
Year:
1971
Bibliographic source:
Cited in RIFM Database, Location 1805;

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Human maximization study was conducted on 25 male volunteers.
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was conducted.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): p-Methylanisloe
- Analytical purity: no data given

Method

Type of population:
not specified
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 25
- Sex: male
- Age: no data given
- Race: no data given
Clinical history:
no data
Controls:
no data
Route of administration:
dermal
Details on study design:
Closed patch applications with the test material in petrolatum were made to the same site on the volunteers´forearms for 5 alternate day 48-hour periods.
Patch sites were pretreated with 5 % sodium lauryl sulphate (SLS) for 24 hours.
Following a 10 day rest period, challenge patches were applied to fresh sites under occlusion for 48 hours and the challenge sites were pretreated for 1 hour with 10 % SLS under occlusion.
The sites were read at patch removal (48 h) and 48 h after patch removal (72 h).

Results and discussion

Results of examinations:
According to the authors, no sensitization effects were seen when using 2 % of the test material.
In the 48-hour closed patch test, performed prior to the human maximization study, no irritating effects were observed using 2 % of the test material.

Applicant's summary and conclusion