Registration Dossier
Registration Dossier
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EC number: 250-705-4 | CAS number: 31566-31-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 Mar - 09 Mar 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions. Lack of study details and no information on analytical purity of the substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- lack of study details; no information on analytical purity of the substance
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Stearic acid, monoester with glycerol
- EC Number:
- 250-705-4
- EC Name:
- Stearic acid, monoester with glycerol
- Cas Number:
- 31566-31-1
- Molecular formula:
- C21H42O4
- IUPAC Name:
- stearic acid, monoester with glycerol
- Details on test material:
- - Name of test material (as cited in study report): Stearate de Glycerol
- Analytical purity: no data
- Lot/batch No.: 1412F
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: NMRI EOPS
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 20-21 g
- Fasting period before study: 4 h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 40 mL/kg bw
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 6 days
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities were reported during the 6-day observation period.
- Clinical signs:
- other: Within the first hour post-administration, clinical observations included eyes half closed, shortness of breath and apathy. Two hours after administration, animals received their normal diet and no clinical signs were noted at this time point.
- Gross pathology:
- No abnormalities observed.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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