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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

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:
disregarded due to major methodological deficiencies
Reliability:
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
Reference Type:
publication
Title:
High sensitization rate to emulsifiers in patients with chronic leg ulcers
Author:
Pasche-Koo, F. et al.
Year:
1994
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:
232-360-1
EC Name:
Sorbitan, (Z)-9-octadecenoate (2:3)
Cas Number:
8007-43-0
Molecular formula:
C42H76O7
IUPAC Name:
(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

Method

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

Results:
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