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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Limited documentation (analytical purity of test substance not specified, 7-day observation period).
Data source
Reference
- Reference Type:
- publication
- Title:
- The oral Toxicity and Pathology of Polyethoxyethylene Derivatives in Rats and Hamsters
- Author:
- Eagle, E. and Poling, C.E.
- Year:
- 1 956
- Bibliographic source:
- Food research 21: 348
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- (analytical purity of test substance not specified, 7-day observation period)
- Principles of method if other than guideline:
- Acute oral toxicity test in rats.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
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): Polyoxyethylene-20-sorbitan monolaurate (PSML)
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 150 - 220 g
- Fasting period before study: 18 h, but water ad libitum
- Housing: individually
- Water : ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25.6 - 27.8
- Humidity (%): 45
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Doses:
- 36700 mg/kg bw
- No. of animals per sex per dose:
- 57
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes - Statistics:
- Calculation of LD50 was made by the method of Reed and Muench (1938).
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 36 700 mg/kg bw
- Based on:
- test mat.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classidied
DSD: not classified
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