Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

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.