Registration Dossier
Registration Dossier
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EC number: 276-171-2 | CAS number: 71902-01-7
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 source (analytical purity of TS not specified, limited documentation).
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 Tri...
- Author:
- Lanigan RS, Yamarik TA; Cosmetic Ingredient Review Expert Panel
- Year:
- 2 002
- Bibliographic source:
- International Journal of Toxicology 21(suppl. 1): 93-112
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- RIPT
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sorbitan, isooctadecanoate
- EC Number:
- 276-171-2
- EC Name:
- Sorbitan, isooctadecanoate
- Cas Number:
- 71902-01-7
- Molecular formula:
- C23H48O8
- IUPAC Name:
- 2-(3,4-dihydroxyoxolan-2-yl)-2-hydroxyethyl 3-methylheptadecanoate
- Details on test material:
- - Name of test material (as cited in study report): sorbitan isostearate
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 201
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test) applied on the upper arm or back
ADMINISTRATION
- Type of application: occlusive, induction period of 48 to 72 hours
- Concentrations: 2.5%
- Volume applied: 0.2 g
- Testing/scoring schedule: patches were applied 3 times per week for 3 weeks, after a 2-week non-treatment period, a 72-hour challenge patch was applied to a previously unexposed skin site.
EXAMINATIONS
Reactions were scored at 96 hours post appliation.
Results and discussion
- Results of examinations:
- NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 201
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0
Applicant's summary and conclusion
- Conclusions:
- The test substance did not induce a sensitisation response in humans under the test conditions chosen.
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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