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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

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:
A human maximization study was conducted on 25 subjects. Occluded applications with the test substance at 4% in petrolatum were made to the same site on the volunteers' forearms for five alternate-day 48-hour periods. The sites were pretreated for 24 hours with 5% sodium lauryl sulfate (SLS) under occlusion. The challenge sites were read at the patch removal and 24 hours after the patch removal.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Method

Type of population:
general
Ethical approval:
no
Subjects:
- Number of subjects exposed: 25
- Age: 18-37
- Race: White 24; Black 1
- Sex: Male: 13, Female: 12
Clinical history:
- healthy
Route of administration:
dermal
Details on study design:
- Concentration: 4% in petrolatum
- Pre-test: A patch of the test material was applied to five subjects to normal sites on the backs for 48 hours under occlusion. No subject had any irritation from this material and it was decided to use SLS pre-treatment in the test.
- Maximization test: Performed according to Maximization Test (J.I.D.; vol. 47; No. 5; 363-409; 1966). The test substance is applied under occlusive dressing to the same site on the volar forearms of all subjects for five alternate-day 48-hour periods. Prior to each exposure, the site was pre-treated with 5% aqueous sodium lauryl sulfate under occlusive dressings for a 24-hour period. The challenge sites were read at the patch removal and 24 hours after the patch removal.

Results and discussion

Results of examinations:
No effects were observed.

Applicant's summary and conclusion