Registration Dossier
Registration Dossier
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EC number: 232-360-1 | CAS number: 8007-43-0
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:
- 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:
- 1 994
- 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
- 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
Constituent 1
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
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