Registration Dossier
Registration Dossier
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EC number: 812-958-4 | CAS number: 1078712-76-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 14, 2016 to November 15, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 1078712-76-1
- Molecular formula:
- C23-27H49-59N (Substance is a UVCB)
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- The test substance was administered once orally via
gavage to 3 fasted female albino rats at a limit dose level of 2000 mg/kg. There were no
mortalities observed, and therefore, 3 additional female rats were administered the test substance
at a dose level of 2000 mg/kg.
Mortality, clinical observations, and body weight changes were evaluated over a 14-day
observation period. All animals were subjected to a gross necropsy.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- None
- Body weight:
- Unaffected
- Gross pathology:
- No findings
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Based on the results of this study, the estimated LD50 of amines (2-ethylhexyl)(hydrogenated
tallow alkyl) methyl was greater than 2000 mg/kg when administered as a single oral dose in
female albino rats.
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