Registration Dossier
Registration Dossier
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EC number: 215-664-9 | CAS number: 1338-41-6
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only short abstract available
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
- Principles of method if other than guideline:
- 11-week feeding study in monkeys
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sorbitan, (Z)-9-octadecenoate (2:3)
- EC Number:
- 232-360-1
- EC Name:
- Sorbitan, (Z)-9-octadecenoate (2:3)
- Cas Number:
- 8007-43-0
- IUPAC Name:
- 1,4-anhydro-5,6-di-O-oleoyl-D-glucitol
- Details on test material:
- - Name of test material (as cited in study report): Sorbitan sesquioleate
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- monkey
- Strain:
- other: rhesus
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 11 weeks
- Frequency of treatment:
- feeding
Doses / concentrations
- Remarks:
- Doses / Concentrations:
no data
Basis:
no data
- No. of animals per sex per dose:
- 2
- Control animals:
- yes
Examinations
- Other examinations:
- no data
- Statistics:
- no data
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- There were no signs of intoxication.
- Mortality:
- no mortality observed
- Description (incidence):
- There were no signs of intoxication.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- There was a slight loss in body weight which was not considered significant.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- There were no pathological alterations in the livers or kidneys.
- Histopathological findings: neoplastic:
- not specified
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- mg/kg diet
- Basis for effect level:
- other: no data on test substance concentration was given in the study report
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Target system / organ toxicity
- Critical effects observed:
- not specified
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.
