Registration Dossier
Registration Dossier
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EC number: 203-990-4 | CAS number: 112-61-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-05-12 to 1992-05-26
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- analytical purity of test material not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Methyl stearate
- EC Number:
- 203-990-4
- EC Name:
- Methyl stearate
- Cas Number:
- 112-61-8
- Molecular formula:
- C19H38O2
- IUPAC Name:
- methyl octadecanoate
- Details on test material:
- - Name of test material (as cited in study report): octadecanoic acid, methyl ester
- Physical state: Solid, white
- Analytical purity: not given
- Impurities (identity and concentrations): Not given
- Purity test date: Not given
- Stability under test conditions: Stable in arachidis oil
- Storage condition of test material: RT
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann GmbH, Germany
- Age at study initiation: Approx. 10 weeks
- Weight at study initiation: Mean weights: Male: 176 g, Female: 157 g
- Housing: Groups of 5 animals in Makrolon Type 3 cages
- Fasting period before study: 16 h before until 3 h after dosing
- Diet (e.g. ad libitum): ad libitum (Altromin Maintainance diet 1324)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Humidity (%): 43-75
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20% (g/v)
- Amount of vehicle (if gavage): 10 mL/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Maximum dose recommended - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality/Toxicity At frequent intervalls during test day one and twice daily on days 2 - 14; body weight on days -1, 1, 2, 7 and 14
- Necropsy of survivors performed: yes, Macroscopic examintion of all external orifices and the organs in thoracic and visceral cavity
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No deaths occurred (one dead female animal after 11 days was not related to treatment)
- Clinical signs:
- other: No symptoms observed
- Gross pathology:
- Male: No findings considered to be related to treatment
Female: One animal cannibalism of the abdomen and the back extremities
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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