Registration Dossier
Registration Dossier
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EC number: 812-656-2 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- June 04th, 1992 - June 18th, 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation. Only basic data on test material given
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- : Only basic data on test material given
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-ethyl-2-[[(1-oxooleyl)oxy]methyl]-1,3-propanediyl dioleate
- EC Number:
- 260-895-0
- EC Name:
- 2-ethyl-2-[[(1-oxooleyl)oxy]methyl]-1,3-propanediyl dioleate
- Cas Number:
- 57675-44-2
- Molecular formula:
- C60H110O6
- IUPAC Name:
- 2,2-bis[(oleoyloxy)methyl]butyl octadec-9-enoate (non-preferred name)
- Details on test material:
- - Physical state: yellow, liquid
- Lot/batch No.: 2035/406
- Storage condition of test material: RT
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: ICO: OFA-SD (IOPS Caw)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa Crédo, France
- Age at study initiation: 6 weeks
- Weight at study initiation: 187 +/- 6 g for males and 153 +/- 6 g for females
- Housing: 5 animals per polycarbonate cage (48x27x20 cm)
- Fasting period before study: 18 h before until 4 h after dosing
- Diet (e.g. ad libitum): ad libitum (Rats - Mice substance ref. A04 C)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED:2.20 ml/kg
- Doses:
- 2000 mg/kg bw taking into account the specific gravity of 0.912
- 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: daily, weighing on days 1, 5, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology - Statistics:
- Not applicable
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: No clinical signs at any time point
- Gross pathology:
- No apparent abnormalities
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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