Registration Dossier
Registration Dossier
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EC number: 942-072-4 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 12 - 18 Mar 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
- Principles of method if other than guideline:
- To determine the LD50 of the test substance, 5000 mg/kg bw was administered to 5 female mice orally. The mice were observed for mortality and signs of toxicity for 6 days after dosing. The body weights were recorded on day 0 prior to dosing and on day 6.
- GLP compliance:
- not specified
- Test type:
- standard acute method
Test material
- Reference substance name:
- Fatty acids, C8-10, C12-18-alkyl esters
- EC Number:
- 306-082-7
- EC Name:
- Fatty acids, C8-10, C12-18-alkyl esters
- Cas Number:
- 95912-86-0
- IUPAC Name:
- 95912-86-0
- Details on test material:
- - Name of test material (as cited in study report): coco caprylate/caprate
- Analytical purity: no data
- Physical state: clear liquid
- Lot/batch No.: 0907 D
- Density: 0.828 g/mL
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: 19-20 g
- Fasting period before study: 4 h
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 6 mL/kg bw
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 6 days
- Frequency of observations and weighing: the animals were observed for mortality and signs of toxicity daily; the body weight was recorded on day 0 prior to dosing and on day 6
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, mortality, body weight
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: No signs of toxicity were 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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