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:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

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

Materials and methods

Endpoint addressed:
skin irritation / corrosion
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Ethical approval:
not specified
Exposure assessment:
measured
Details on exposure:
TYPE OF EXPOSURE: occlusive patch

TYPE OF EXPOSURE MEASUREMENT: Exposure pads

EXPOSURE LEVELS: concentrated test item

EXPOSURE PERIOD: 24 h

POSTEXPOSURE PERIOD: 48 and 72 h

DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES: one exposure group

Results and discussion

Results:
At 24, 48 and 72 hour reading, no skin irritation was observed.

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study, the test article is not irritating to human skin.
Executive summary:

The purpose of this study was to determine the epicutaneous irritation potential of the test article in humans. A closed patch test was used according to the method of Jadassohn and Bloch. There were 21 sensitive skin people included in the study with a total of 60 people placed on test. The patches were applied to the back or inner side of the upper arm and covered in an airtight manner with bandage material. The patch was removed after 24 hours and the site scored. The site was also scored at 48 and 72 hours.

Under the conditions of this study, the test article is not irritating to human skin. There were no skin reactions noted.