Alcohols, C16-18, reaction products with D-glucose

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Test procedure according to national standards

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1999

Materials and methods

Type of study / information:

A single application closed patch epicutaneous test under occlusion was performed in 20 male and female, healthy volunteers for a period of 24 h to determine the skin irritating potential of the test substance for the evaluation of skin compatibility.

Endpoint addressed:

skin irritation / corrosion

Test guideline

Qualifier:

according to guideline

Guideline:

other: Guidelines for the Assessment of Skin Tolerance of Potentially Irritant Cosmetic Ingredients (COLIPA, 1997)

Deviations:

no

GLP compliance:

yes

Remarks:

according to GCP

Test material

Test material information

Constituent 1

Reference substance name:

not applicable, UVCB substance

Molecular formula:

not applicable, UVCB substance

IUPAC Name:

not applicable, UVCB substance

Constituent 2

Reference substance name:

928-176-2

EC Number:

928-176-2

IUPAC Name:

928-176-2

Details on test material:

- Name of test material (as cited in study report): trade name given
- Physical state: white solid
- Analytical purity: 20% AS in cosmetic alcohol
- Composition of test material, percentage of components: 30% C16/C18-APG, 70% C16/C18 fatty alcohols

Method

Ethical approval:

not specified

Details on study design:

The test substance (70 µL) at 20% AS (active substance content) was each applied to an occlusive patch (Finn Chamber on Scanpor, 12 mm diameter) and placed on the back of the volunteers. After 24 h exposure, patches were removed and skin irritation was monitored for 6, 24, 48 and 72 h. Different reference substances (1% AS Texapon N25, 0.5% AS sodium dodecyl sulphate (SDS), demineralised water, physiological saline and cosmetic alcohol) were tested in parallel. The skin compatibility was assessed by comparison to the reference substances SDS and Texapon N25.

Details on exposure:

TYPE OF EXPOSURE: epicutaneous, occlusive

TYPE OF EXPOSURE MEASUREMENT: based on calculation

EXPOSURE LEVELS: 20% AS in cosmetic alcohol

EXPOSURE PERIOD: 24 h

POSTEXPOSURE PERIOD: 6, 24, 48 and 72 h

DESCRIPTION OF EXPOSURE GROUPS:
- Number of subjects exposed: 20 healthy volunteers
- Sex: male and female
- Age: not restricted

Results and discussion

Results:

After exposure to the test substance (20% AS), 2 moderate erythema and slight scaling were observed. The mean scores after 6, 24, 48 and 72 h were 0.2 for erythema and 0.45 for erythema, oedema, scaling and fissure. The skin compatibility of the test substance compared to 1% AS Texapon N25 and 0.5% AS SDS was good.

Applicant's summary and conclusion

Conclusions:

After 24 h exposure period, the test substance at 20% AS in cosmetic alcohol was not irritating to human skin.