Registration Dossier
Registration Dossier
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EC number: 500-018-3 | CAS number: 9005-64-5 1 - 6.5 moles ethoxylated
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Original data not available (analytical purity of test substance not specified, 7-day observation period, limited documentation).
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Final Report on the Safety Assessment of Polysorbates 20, 21, 40, 60, 61, 65, 80, 81 and 85
- Year:
- 1 984
- Bibliographic source:
- Journal of the American College of Toxicology 3(5)
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- (analytical purity of test substance not specified, 7-day observation period, limited documentation)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Sorbitan monolaurate, ethoxylated
- EC Number:
- 500-018-3
- EC Name:
- Sorbitan monolaurate, ethoxylated
- Cas Number:
- 9005-64-5
- Molecular formula:
- Molecular formula cannot be given as substance is a mixture.
- IUPAC Name:
- Sorbitan monolaurate, ethoxylated (1-6.5 moles ethoxylated)
- Details on test material:
- - Name of test material (as cited in study report): Polysorbate 20
Constituent 1
Test animals
- Species:
- guinea pig
- Strain:
- other: albino
- Sex:
- not specified
Administration / exposure
- Type of coverage:
- occlusive
- Details on dermal exposure:
- TEST SITE
- Area of exposure: on the back and flank - Duration of exposure:
- 24 hours
- Doses:
- 3000 mg/kg
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 3 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortalities observed
- Clinical signs:
- other: no clinical signs observed
- Gross pathology:
- no abnormalities at necropsy
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DSD: not classified
CLP: not classified
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