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Diss Factsheets

Toxicological information

Exposure related observations in humans: other data

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Administrative data

exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Limited data given (no data on test substance purity, patients with skin diseases were used, only 10% test substance evaluated).

Data source

Reference Type:
High sensitization rate to emulsifiers in patients with chronic leg ulcers
Pasche-Koo, F. et al.
Bibliographic source:
Contact Dermatitis 31: 226-228

Materials and methods

Endpoint addressed:
skin irritation / corrosion
skin sensitisation
Principles of method if other than guideline:
Patients with chronic or recurrent inflammatory skin diseases and healthy volunteers were patch tested with the test substance among other emulsifying agents.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Sorbitan, (Z)-9-octadecenoate (2:3)
EC Number:
EC Name:
Sorbitan, (Z)-9-octadecenoate (2:3)
Cas Number:
Molecular formula:
(1R)-1-[(2R,3R,4S)-4-hydroxy-3-[(9Z)-octadec-9-enoyloxy]oxolan-2-yl]-2-[(9Z)-octadec-9-enoyloxy]ethyl (9Z)-octadec-9-enoate; (2R)-2-[(2R,3R,4S)-3,4-dihydroxyoxolan-2-yl]-2-hydroxyethyl (9Z)-octadec-9-enoate; (2R)-2-hydroxy-2-[(2R,3R,4S)-3-hydroxy-4-[(9Z)-octadec-9-enoyloxy]oxolan-2-yl]ethyl (9Z)-octadec-9-enoate
Details on test material:
- Name of test material (as cited in study report): sorbitan sesquioleate


Ethical approval:
not specified
Details on study design:
The volunteers were patch tested (Finn Chambers on Scanpor tape) with the test substance (10% in petrolatum) for 2 days. Reactions were read at 2, 3 and 4 days. Doubtful reactions were not considered positive.

Results and discussion

One patient had a (+) reaction to the test substance and two other patients a (++) reaction. Of the healthy volunteers, no positive reaction was seen in the control group of 10 healthy subjects.

Applicant's summary and conclusion