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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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only secondary source (analytical purity of test substance not given).

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Final Report on the Safety Assessment of Sorbitan Stearate, Sorbitan Laurate, Sorbitan Sesquioleate, Sorbitan Oleate, Sorbitan Tristearate, Sorbitan Palmitate, and Sorbitan Triolate
Author:
Elder, R.L., ed.
Year:
1985
Bibliographic source:
Journal of the American College of Toxicology 4(3): 65-121
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Endpoint addressed:
skin irritation / corrosion
Principles of method if other than guideline:
Human patch test.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): sorbitan tristearate

Method

Details on study design:
A Schwartz prophetic patch test was conducted using a 40% aqueous solution of the test substance (10 panelists) and the undiluted pure ingredient (201 panelists).

Results and discussion

Results:
Irritation was neither observed in the 10 panelists treated with the 40% solution nor in the 201 people treated with the undiluted ingredient.

Applicant's summary and conclusion

Conclusions:
No irritation was observed in humans when treated with the undiluted test substance.