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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Purity not known.

Data source

Reference
Reference Type:
publication
Title:
Dermal Irritating Properties of Essential oils and Aromatic Chemicals
Author:
Katz A.E.
Year:
1946
Bibliographic source:
The Spice Mill 69: 46-47

Materials and methods

Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline followed
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Ethical approval:
not specified
Details on study design:
The test was conducted on adult human male and female volunteer subjects. The test substance was applied in the pure from to an area approximately 1 cm in diameter on the dermis of the inner portion of the lower arm. Immediately following application, the area was covered with an adhesive bandage which was allowed to remain for a period of 24 hours. The test was read at 24-hour intervals for a 5-day period. Applications which produced visible inflamation, irritation, formation of a popular rash, or any abnormal condition of the area, were considered as positive reactions.
Details on exposure:
TYPE OF EXPOSURE: human patch test
Not specified
Details on study design
The test was conducted on adult human male and female volunteer subjects. The test substance was
applied in the pure from to an area approximately 1 cm in diameter on the dermis of the inner portion of
the lower arm. Immediately following application, the area was covered with an adhesive bandage which
was allowed to remain for a period of 24 hours. The test was read at 24-hour intervals for a 5-day period.
Applications which produced visible inflamation, irritation, formation of a popular rash, or any abnormal
condition of the area, were considered as positive reactions.
Details on exposure
TYPE OF EXPOSURE: human patch test
CONCENTRATION: 100 % (undiluted)
EXPOSURE PERIOD: 24 hours
POSTEXPOSURE PERIOD: The test was read after 24-hour intervals for a 5-day period.
CONCENTRATION: 100 % (undiluted)

EXPOSURE PERIOD: 24 hours

POSTEXPOSURE PERIOD: The test was read after 24-hour intervals for a 5-day period.

Results and discussion

Results:
The test substance was non-irritation in a human patch test.

Applicant's summary and conclusion

Conclusions:
The test substance was non-irritation in a human patch test.
Executive summary:

In this study, the irritating properties of several chemicals, including the test item, were tested in a dermal human patch test. The test was conducted on adult human male and female volunteer subjects. The test substance was applied in the pure from to an area approximately 1 cm in diameter on the dermis of the inner portion of the lower arm. Immediately following application, the area was covered with an adhesive bandage which was allowed to remain for a period of 24 hours. The test was read at 24-hour intervals for a 5-day period. Applications which produced visible inflammation, irritation, formation of a popular rash, or any abnormal condition of the area, were considered as positive reactions. In 24 patch tests with the test item, only one positive reaction was observed. Thus, the test item can be considered as non-irritating to the human skin.