Registration Dossier
Registration Dossier
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EC number: 203-835-0 | CAS number: 111-11-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 Feb - 16 Feb 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Methyl octanoate
- EC Number:
- 203-835-0
- EC Name:
- Methyl octanoate
- Cas Number:
- 111-11-5
- Molecular formula:
- C9H18O2
- IUPAC Name:
- methyl octanoate
- Details on test material:
- - Name of test material (as cited in study report): C8 Methyl Caprylate
- Physical state: liquid, colourless
- Analytical purity: 90-100%
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
- Weight at study initiation: 185 g (males), 164 g (females)
- Housing: Makrolon Type 3 cages
- Fasting period before study: 16 h before until 3 h after dosing
- Diet: Altromin Maintenance diet 1324, ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-60
- 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%
- Amount of vehicle (if gavage): 10 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - 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: clinical observations were done twice daily, weighing on days -1, 1, 2, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
- Gross pathology:
- Necropsy revealed no substance-related findings.
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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