Dehydrated sorbitol, C18 (unsaturated) fatty acid esters, ethoxylated

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Type of information:

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

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented publication which meets basic scientific principles. No data on analytical purity of the test substance.

Data source

Reference

Reference Type:

review article or handbook

Title:

Determination of skin irritation potential in the human 4-h patch test

Author:

Basketter, D.A. et al.

Year:

2004

Bibliographic source:

Contact Dermatitis 51(1): 1-4

Materials and methods

Type of study / information:

A single application closed patch epicutaneous test under occlusion was performed in 29 volunteers for a period of up to 4 h to determine the skin irritating potential of the test substance.

Endpoint addressed:

skin irritation / corrosion

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

yes

Remarks:

no data on analytical purity of the test substance; a volume of 0.2 mL of the test substance instead of the recommended 0.07 to 0.1 mL was applied to the skin

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Sorbitan monooleate, ethoxylated

EC Number:

500-019-9

EC Name:

Sorbitan monooleate, ethoxylated

Cas Number:

9005-65-6

Molecular formula:

Not applicable as UVCB

IUPAC Name:

Sorbitan, C18-unsat, fatty acid esters, ethoxylated (1 - 6.5 moles ethoxylated)

Constituent 2

Reference substance name:

Tween 80

IUPAC Name:

Tween 80

Details on test material:

- Name of test material (as cited in study report): Tween 80
- Analytical purity: no data

Method

Ethical approval:

not specified

Details on study design:

The patch test procedure involved application of 0.2 mL of the test substance on a 25 mm plain Hill Top Chamber containing a Webril pad (Hill Top Companies, Cincinnati, Ohio, USA) to the skin of the upper outer arm of 29 human volunteers for up to 4 h. To avoid the production of unacceptably strong reactions, the test substance was applied progressively from 15 and 30 min through 1, 2, 3 and 4 h. Each progressive application was performed at a new skin site.
Treatment sites were assessed for the presence of irritation using a 4 point scale (Table 1 under “Any other information on materials and methods incl. tables) at 24, 48 and 72 h after patch removal.
A volunteer with a (+) or greater reaction at any of the assessments was considered to have demonstrated a positive irritant reaction, and treatment with the causative substance did not proceed on that person.
For panellists with a (+) or greater response at application times of less than 4 h to a particular test substance, it was assumed that they would present a stronger irritant reaction if exposed for 4 h. However, once a + or greater response was obtained, there was no need to subject these panellists to further treatment with that substance. In evaluating the results, what was measured was the number of panellists who had, or would have had, a positive irritant reaction after a 4-h exposure.
The interpretation of the results was done by statistical comparison of the data with a concurrent positive control (20% sodium dodecyl sulphate (SDS)) in the same panel of volunteers.
The basis for the classification decisions on the prospective human data was as follows: where the incidence of positive irritation reactions to the undiluted test substance was significantly greater than or not significantly different (using Fisher’s exact test) than the level of reaction in that same panel of volunteers to 20% SDS, the substance should be classified as irritant to skin; where the level of reaction was substantially and significantly lower than the response to SDS, then the substance was not classified.

Details on exposure:

TYPE OF EXPOSURE: epicutaneous, occlusive

EXPOSURE LEVELS: undiluted test substance

EXPOSURE PERIOD: up to 4 h (applied progressively from 15 and 30 min through 1, 2, 3 and 4 h)

POSTEXPOSURE PERIOD: 24, 48 and 72 h

DESCRIPTION OF EXPOSURE GROUPS:
- Number of subjects exposed: 29 healthy volunteers

Results and discussion

Results:

Only in 1/29 (ca. 3%) individuals a positive irritant reaction to the test material was observed. In contrast, 24/29 (ca. 83%) individuals from the same panel showed a positive irritant reaction to the 20% sodium dodecyl sulphate control. As the reactions to the test substance were substantially and significantly lower than the response to SDS, the substance was not considered to be a human skin irritant.

Applicant's summary and conclusion

Conclusions:

After the 4-h exposure period, the undiluted test substance was not irritating to human skin.