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:
secondary literature

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1967
Report Date:
2001

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
The present test was conducted with 40 human male volunteers to determine whether the test compound was a sensitizer to human skin or not. The test was conducted according to Shelanski & Shelanski (Repeated Occluded Patch Test, 1953).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
purity: >96%

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
40 male volunteers
Route of administration:
dermal
Details on study design:
Twenty-five mg aliquots of the test substance, as a 20% w/v mixture in talc, was spread evenly over a quartered lintine disc and affixed to the skin of 40 male volunteers. The disks were covered with polypropylene and secured with Blenderm tape. The patches remained in place for 24 hours, at which time the sites of contact were examined and visible skin changes graded and recorded. The contact sites were re-examined again 24 and 48 hours after removal of the patches. Fourteen days after the initial contact, the entire procedure was repeated, challenging the same contact sites in each volunteer. Talc was used as the diluent and control material throughout the test.

Results and discussion

Results of examinations:
The results indicated that the test item in all cases, was capable of eliciting visible skin changes deemed characteristic of a primary skin irritant. It was not capable of eliciting visible skin changes deemed characteristic of a fatiguing agent or a skin sensitizer.

Applicant's summary and conclusion