Fatty acids, montan-wax, stearyl esters

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Cross-reference

Reason / purpose for cross-reference:

read-across source

Reference

Endpoint:

exposure-related observations in humans: other data

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

21 - 24 Dec 2004

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.

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

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:

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.

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

Conclusions:

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

Materials and methods

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, montan-wax, stearyl esters

EC Number:

269-642-9

EC Name:

Fatty acids, montan-wax, stearyl esters

Cas Number:

68308-30-5

Molecular formula:

C18 H38 O - C66 H130 O4

IUPAC Name:

Fatty acids C22-30 (even numbered), octadecyl alcohol esters

Results and discussion

Results:

A single patch test was available with the source substance CAS 17671-27-1. In this study, 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.

Applicant's summary and conclusion

Conclusions:

The source substance docosyl docosanoate (CAS 17671-27-1) did not show skin irritant properties under the chosen test conditions. Applying the read-across approach, similar results are expected for the target substance.