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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable and well documented publication, no single scores were documented, only 20 % pure substance in peanut oil was tested.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Type of study / information:
Human patch test (skin irritation)
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
In an human patch test the test item was tested in a 20 % suspension in vaseline on 50 persons.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Ethical approval:
not specified
Details on study design:
STUDY PERIOD: Time of exposition was 24 hours, reaction was examined immediately after removal of the testing patch and 24 hours later.

STUDY POPULATION
- Total number of subjects participating in study: 50 (40 with eczema of various kinds)
- Sex/age/race: 21 women, 29 men
Exposure assessment:
not specified
Details on exposure:
TYPE OF EXPOSURE: Human closed patch test

EXPOSURE PERIOD: 24 hours

Results and discussion

Results:
The preparation was tolerated by all persons without pathological findings. No skin irritation potential was observed.

Applicant's summary and conclusion

Conclusions:
In a human patch test the test item was tested in a 20 % suspension in vaseline on 50 persons. No adverse skin irritation reactions were observed.
Executive summary:

In a human patch test the skin irritation potential of the test item was tested in a 20 % suspension in vaseline on 50 persons. The test area on the body was the shoulder blade. The test was performed by the patch skin test. As testing patch Leukosilk was used. The time of exposure was 24 hours. The reaction to the test was examined 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 50 persons (21 female, 29 male). 40 persons had eczema of various kinds. Reactions were read at patch removal and again 24 hours after patch removal.Therefore the test was conducted under especially “hard” conditions. No skin irritation reactions were observed.