Registration Dossier
Registration Dossier
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EC number: 254-599-0 | CAS number: 39711-79-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from publication.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Safety Evaluation of Certain Food Additives
- Author:
- WHO
- Year:
- 2 006
- Bibliographic source:
- WHO
- Reference Type:
- review article or handbook
- Title:
- review article - Test chemical
- Author:
- World Health Organization
- Year:
- 2 006
- Bibliographic source:
- WHO
- Reference Type:
- secondary source
- Title:
- Compounds in Flavor Usage
- Author:
- Food and Drug Administration
- Year:
- 1 983
- Bibliographic source:
- Food and Drug Administration
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Acute oral toxicity dose for the substance was determined in rats.
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
Test material
- Reference substance name:
- N-ethyl-2-(isopropyl)-5-methylcyclohexanecarboxamide
- EC Number:
- 254-599-0
- EC Name:
- N-ethyl-2-(isopropyl)-5-methylcyclohexanecarboxamide
- Cas Number:
- 39711-79-0
- Molecular formula:
- C13H25NO
- IUPAC Name:
- N-ethyl-2-(isopropyl)-5-methylcyclohexanecarboxamide
- Details on test material:
- - IUPAC Name: N-ethyl-2-(isopropyl)-5-methylcyclohexanecarboxamide
- InChI: 1S/C13H25NO/c1-5-14-13(15)12-8-10(4)6-7-11(12)9(2)3/h9-12H,5-8H2,1-4H3,(H,14,15)
- Smiles:C1[C@@H](CC[C@@H](C(C)C)[C@@H]1C(NCC)=O)C
- Molecular formula :C13H25NO
- Molecular weight :211.346 g/mol
- Substance type:Organic
- Physical state:solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CFY
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 10% suspension in 0.5% carboxymethylcellulose
- Details on oral exposure:
- not specified
- Doses:
- 2900 mg/kg bw
- No. of animals per sex per dose:
- not specified
- Control animals:
- not specified
- Details on study design:
- not specified
- Statistics:
- not specified
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 900 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 2 400 - 3 400
- Mortality:
- 50% mortality was observed at 2900 mg/kg bw in treated animals.
- Clinical signs:
- other: not specified
- Gross pathology:
- not specified
- Other findings:
- not specified
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- The acute oral LD50 value was determined to be 2900 mg/kg bw, with 95% confidence limit of 2400-3400 mg/kg bw, when male and female CFY rats were treated with the given test substance via oral gavage route.
- Executive summary:
The acute oral toxicity study was conducted by using of the given test chemical inmale and female CFY rats at the dose concentration of 2900 mg/kg bw.
The given test chemical was prepared as 10% suspension in 0.5% carboxymethylcellulose and administered via oral route.
The animals were observed for mortality. 50% mortality was observed at 2900 mg/kg bw in treated animals.
Hence, the LD50 valuewas determined to be 2900 mg/kg bw, with 95% confidence limit of 2400-3400 mg/kg bw, when male and female CFY rats were treated with the given test substance via oral gavage route.
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