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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:
1992
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

Constituent 1
Chemical structure
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 stearate
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

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:
No symptoms observed
Body weight:
Normal body weight gain
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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