Isohexadecyl 12-[(1-oxooctadecyl)oxy]octadecanoate

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

Test material information

Constituent 1

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.