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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

Reference
Name:
Unnamed
Type:
Constituent
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