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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only secondary literature available (no data on test substance purity).

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Final Report on the Safety Assessment of Sorbitan Caprylate, Sorbitan Cocoate, Sorbitan Diisostearate, Sorbitan Dioleate, sorbitan Distearate, Sorbitan Isostearate, sorbitan Olivate, Sorbitan Sesquiisostearate, Sorbitan Sesquistearate and Sorbitan Triiso
Author:
Croda
Year:
2002
Bibliographic source:
International Journal of Toxicology, 21 (Supp1): 93-112
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 Amercian College of Toxicology, Vol.4, No.3
Reference Type:
publication
Title:
Unpublished human irritation studies and animal toxicology and irritation studies of Span 20 (sorbitan laurate), Span 40 (sorbitan palmitate), Span 60 (sorbitan stearate), Span 65 (sorbitan tristearate), Span 80 (sorbitan oleate), Span 85 (sorbitan trio
Author:
CTFA
Year:
1981
Report Date:
1981

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Schwartz prophetic 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
- Analytical purity: not given

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 211 - 10 to 100% test substance, 201 to 40% in water
Controls:
no data
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: no irritation observed, no sensitization, except one exposed to 40 % test substance in water

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 1
- Number of subjects with negative reactions: 210

Applicant's summary and conclusion