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EC number: 634-657-5 | CAS number: 65962-45-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study conducted to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- 4-[(4-amino-3,5-dimethylcyclohexyl)methyl]-2,6-dimethylcyclohexan-1-amine
- EC Number:
- 634-657-5
- Cas Number:
- 65962-45-0
- Molecular formula:
- C17H34N2
- IUPAC Name:
- 4-[(4-amino-3,5-dimethylcyclohexyl)methyl]-2,6-dimethylcyclohexan-1-amine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Remarks:
- 2000 mg/kg bw: undiluted and 300 mg/kg bw: solution
- Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 300 mg/kg bw in 6 females and 2000 mg/kg bw in 3 females
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 300 mg/kg bw: 2/6 animals died on study day 1 or delayed on study day 6
2000mg/kg bw: 3/3 animals were found dead within 1 hour after the administration - Clinical signs:
- other: 300mg/kg bw: impaired general state, dyspnoea, piloerection, reduced feces 2000 mg/kg bw: poor general state, impaired general state, gasping, staggering, respiration noises
- Gross pathology:
- 2000mg/kg bw: lung: dark red spotted discoloration in all lobes; liver: dark red spotted discoloration; stomach: clear liquid content; glandular stomach: extended bleeding; small intestine: intensive red discoloration and red discoloration of content
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study the median lethal dose of 4,4'-Diamino-3,3',5,5'-tetramethyl-dicyclohexylmethane after oral administration was found to be greater than 300 mg/kg bw and less than 2000 mg/kg bw in rats.
- Executive summary:
In an acute oral toxicity study performed according to the Acute Toxic Class method, doses of 2000 and 300 mg/kg bw of the test item 4,4'-Diamino-3,3',5,5'-tetramethyldicyclohexylmethane (undiluted or preparations in olive oil Ph./Eu.) were administered to three test groups of three fasted Wistar rats each (2000 mg/kg bw in 3 females, 300 mg/kg bw in 6 females) by gavage in a sequential manner.
Under the conditions of this study the median lethal dose of 4,4'-Diamino-3,3',5,5'-tetramethyl-dicyclohexylmethane after oral administration was found to be greater than 300 mg/kg bw and less than 2000 mg/kg bw in rats.
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