Registration Dossier
Registration Dossier
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EC number: 232-360-1 | CAS number: 8007-43-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Does not meet important criteria of todays stadard methods (analytical purity of test substance not provided, only 3% test substance evaluated, test substance part of a cosmetic cleansing cream, no information on doses).
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:
- 1 968
- Report date:
- 1968
Materials and methods
- Principles of method if other than guideline:
- Cosmetic cleansing cream containing 3% of test substance was tested in a patch test after 24 hour exposure. 14 days observation time.
- GLP compliance:
- no
- Test type:
- standard acute method
Test material
- Reference substance name:
- 8007-43-0 [purity: 3%]
- IUPAC Name:
- 8007-43-0 [purity: 3%]
- Details on test material:
- - Name of test material (as cited in study report): sorbitan sesquioleate
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: albino
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Duration of exposure:
- 24 hours
- Doses:
- 200 and 300 mg/kg bw (3% of 6800 and 10200 mg/kg bw applied cleansing cream)
- No. of animals per sex per dose:
- 2
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, dermal effects
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality observed.
- Clinical signs:
- other: Definite erythema at application site was observed.
- Gross pathology:
- No data
Applicant's summary and conclusion
- Interpretation of results:
- other: inconclusive
- Remarks:
- Criteria used for interpretation of results: EU
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