Registration Dossier

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:
secondary literature

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1970
Report Date:
2001

Materials and methods

Type of study / information:
Patch test
Endpoint addressed:
skin irritation / corrosion
Principles of method if other than guideline:
The present primary skin Irritation study was conducted with 10 human volunteers (5 men, 5 women) to determine whether the test compound was irritating to human skin or not. The test was conducted according to Shelanski & Shelanski (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

Ethical approval:
not specified
Details on study design:
Ten human volunteers (5 men, 5 women) were selected. Three areas of 3 cm x 3 cm each, were selected on the skin of the left arm of each individual. 10 mg of the test substance was applied to each area as a finely ground powder. The powder was covered with a lintine disc and secured to the arm by sealing around the edges with Blenderm tape.
Exposure assessment:
measured
Details on exposure:
After 2 hours, the cover of one contact area was removed from each subject, the powder was lightly brushed away, and the site examined for skin reactions.
After 4 hours, the second disk was removed and the skin examined.
After 6 hours, the third disk was removed and the skin examined.
All treatment sites were examined immediately after disk removal, and then again at 1, 4 and 24 hour intervals.

Results and discussion

Results:
One male subject exhibited slight erythema at 4 hours and marked erythema at 6 hours. One female subject exhibited slight erythema at 6 hours, and one female subject had marked erythema at 6 hours. All reactions disappeared in less than 24 hours.

Applicant's summary and conclusion