Registration Dossier
Registration Dossier
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EC number: 247-891-4 | CAS number: 26658-19-5
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:
- 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:
- 1 985
- Bibliographic source:
- Journal of the American College of Toxicology 4(3): 65-121
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- 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 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
Constituent 1
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.
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.
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