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Exposure related observations in humans: other data

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Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 - 24 Dec 2004
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
The analytical purity of the test substance was not specified.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Type of study / information:
The skin irritation effects (erythema and edema) of occlusive exposure to the test substance for 24 hours was assessed in 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 hours under occlusive conditions. The skin irritation effects (erythema and edema) were assessed 30 minutes and 24 hours after patch removal.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Docosyl docosanoate
EC Number:
241-646-5
EC Name:
Docosyl docosanoate
Cas Number:
17671-27-1
Molecular formula:
C44H88O2
IUPAC Name:
docosyl docosanoate

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 11 volunteers. The test substance was placed 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 the test area with adhesive tape and left for 24 hours. A positive control cup containing 1% solution of sodium sulfate and a negative control cup containing distilled water, was fixed to the skin in parallell with the test cup. The skin irritation effects (erythema, edema, vesicles, cutaneous dryness, wrinkling, glazing) were assessed 30 minutes and 24 hours 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 hours

POSTEXPOSURE PERIOD: 24 hours

Results and discussion

Results:
1/11 subjects were excluded as moderate erythema was noted at the negative control site. Slight to moderate erythema was observed at the test site in 3/10 subjects 30 minutes after exposure ended and in 1/10 24 hours after patch removal. The positive control was shown to be valid, as slight to moderate erythema was noted at the positive control site in 11/11 subjects.

Any other information on results incl. tables

Table 1: individual skin irritation scores

Reading time point

Subject No.

Erythema score

Edema score

30 min.

1

1.5

0

30 min.

2

0

0

30 min.

3

0

0

30 min.

4

1

0

30 min.

5

0

0

30 min.

6

0

0

30 min.

7

0

0

30 min.

8*

0

0

30 min.

9

0

0

30 min.

10

0

0

30 min.

11

1.5

0

24 hours

1

0

0

24 hours

2

0

0

24 hours

3

0

0

24 hours

4

0

0

24 hours

5

0

0

24 hours

6

0

0

24 hours

7

0

0

24 hours

8*

0

0

24 hours

9

0

0

24 hours

10

0

0

24 hours

11

1

0

* result disregarded due to reaction to negative control

Applicant's summary and conclusion

Conclusions:
The test substance was not a skin irritant under the chosen test conditions.