Registration Dossier
Registration Dossier
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EC number: 247-891-4 | CAS number: 26658-19-5
Sensitisation data (human)
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:
- 2 002
- 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:
- 1 985
- 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- Unpublished human irritation studies and animal toxicology and irritation studies of Span 20 (sorbitan laurate), Span 40 (sorbitan palmitate), Span 60 (sorbitan stearate),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:
- 1 981
- 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 substance name:
- Sorbitan tristearate
- EC Number:
- 247-891-4
- EC Name:
- Sorbitan tristearate
- Cas Number:
- 26658-19-5
- Molecular formula:
- Molecular formula cannot be given as substance is a mixture.
- IUPAC Name:
- (2R)-2-[(2R,3R,4S)-3,4-bis(octadecanoyloxy)oxolan-2-yl]-2-hydroxyethyl octadecanoate; (2R)-2-[(2R,3R,4S)-3,4-dihydroxyoxolan-2-yl]-2-hydroxyethyl octadecanoate; (2R)-2-hydroxy-2-[(2R,3R,4S)-3-hydroxy-4-(octadecanoyloxy)oxolan-2-yl]ethyl (9Z)-octadec-9-enoate
- Details on test material:
- - Name of test material (as cited in study report): sorbitan tristearate
- Analytical purity: not given
Constituent 1
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
