Registration Dossier
Registration Dossier
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EC number: 939-270-8 | 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:
- key study
- Study period:
- 1984-05-30 - 1984-06-20
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well conducted study similar to guideline (limited documentation; limit test at ca. 4250 mg/kg bw)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- limit test at ca. 4250 mg/kg bw, limited documentation
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty acids, C16-18, 2-hexyldecyl esters
- EC Number:
- 309-832-1
- EC Name:
- Fatty acids, C16-18, 2-hexyldecyl esters
- Cas Number:
- 101227-09-2
- IUPAC Name:
- 101227-09-2
- Details on test material:
- - Name of test material (as cited in study report): Isohexadecylstearat
No further details provided
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 201.8 g (after fasting)
- Fasting period before study: 17 hours
No additional details provided.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw
- Doses:
- 5 mL/kg bw (corresponding to ca. 4250 mg/kg bw, calculated assuming test substance density of 0.85 g/cm3)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
No further details provided. - Statistics:
- Not applicable
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 4 250 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality occurred at this unique dose level (original value: 5 mL/kg bw; converted assuming test substance density of 0.85 g/cm3).
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: Slight piloerection and slight reduced activity were observed up to 1 hour after treatment. All treated animals appeared normal thereafter.
- Gross pathology:
- No abnormalities were observed at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
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