Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1988
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: short summary of test results, no substance puritiy given, only tested at a concentration of 10 %

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Type of study / information:
human patch test results
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A human patch test was performed on human volunteers.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Ethical approval:
not applicable
Details on study design:
The test material was tested on 43 subjects, 23 of which had eczema.
Exposure assessment:
estimated
Details on exposure:
TYPE OF EXPOSURE: patch test

TYPE OF EXPOSURE MEASUREMENT: Exposure pads

EXPOSURE LEVELS: 10 % suspension

EXPOSURE PERIOD: 24 h

POSTEXPOSURE PERIOD: skin reactions were evaluated after patch removal and 24 hours thereafter.

Results and discussion

Results:
The preparation was tolerated by all persons without pathological findings.

Applicant's summary and conclusion

Conclusions:
The test material at a concentration of 10 % did not cause skin irritation in the human patch test.
Executive summary:

The test material was tested for its potential to cause skin irritation in the human patch test. The concentration of the substance was 10 % (suspension in white petrolatum). The test area on the body was the shoulderblade. As testing patch Leukosilk was used. The time of exposition was 24 hours and skin reactions were evaluated immediately after removal of the testing patch and 24 hours later. The Interpretation of the test reaction was based on the criteria of the International Contact Dermatitis Research Group. The preparation was tested on 43 persons (18 male, 25 female). 23 persons had eczema of various kinds. As a result, no skin reactions were observed and therefore the material was considered to not cause skin irritation.