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:
key study
Study period:
24 Sep - 4 Oct 2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles. The analytical purity of the test substance was not specified.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Type of study / information:
The skin irritation effects caused by occlusive exposure to the test substance for 24 h was assessed in human volunteers.
Endpoint addressed:
skin irritation / corrosion
Principles of method if other than guideline:
In a single exposure patch test, the undiluted test substance was applied to the back skin of volunteers for 24 h under occlusive conditions. The skin irritation effects (erythema, edema, vesicles, cutaneous dryness, wrinkling and glazing) were assessed 30-60 min and 24 h after patch removal.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Ethical approval:
other: subjects signed an 'informed consent'-form
Details on study design:
In a single exposure patch test, 20 µL of the undiluted test substance was applied to the upper back skin of 14 volunteers (13 females, 1 male). In the first step, the test substance was applied to the skin of 3 volunteers for 1, 4, 8 and 24 h. As no severe irritating reactions were observed, in the second step the substance was applied to the upper back of a further 11 subjects for 24 h. The test substance was placed on absorbent paper deposited in an aluminium cup (Finn Chamber Test) measuring 8 mm in diameter with a volume of 20 µL, covering an area of approximately 50 mm². The cup was fixed to adhesive tape, and this test patch was applied to the skin and left for 24 h. A positive control cup containing 1% solution of sodium sulfate and a negative control cup containing distilled water, was applied in parallell with the test cup. The skin irritation effects (erythema, edema, vesicles, cutaneous dryness, wrinkling, glazing) were assessed 30-60 min and 24 h after patch removal and the subjective experience of the volunteers was recorded.
Exposure assessment:
not specified
Details on exposure:
TYPE OF EXPOSURE: dermal

EXPOSURE PERIOD: 24 h

POSTEXPOSURE PERIOD: 24 h

Results and discussion

Results:
1/14 subjects was excluded as moderate erythema was noted at the negative control site, while 1/14 subjects was excluded due to a lack of reaction at the positive control site. No erythema, edema, vesicles, wrinkling, glazing or dryness was noted in any subject 30-60 min and 24 h after patch removal. The positive control was shown to be valid, as slight to moderate erythema was noted at the positive control site in 12/12 subjects.

Applicant's summary and conclusion

Conclusions:
The test substance did not cause skin irritation under the current test conditions.