Registration Dossier
Registration Dossier
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EC number: 252-853-5 | CAS number: 36060-61-4
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- (Z)-2-(8-heptadecenyl)-4,5-dihydro-1H-imidazole-1-ethanol
- EC Number:
- 244-501-4
- EC Name:
- (Z)-2-(8-heptadecenyl)-4,5-dihydro-1H-imidazole-1-ethanol
- Cas Number:
- 21652-27-7
- Molecular formula:
- C22H42N2O
- IUPAC Name:
- 2-(2-heptadec-8-en-1-yl-4,5-dihydro-1H-imidazol-1-yl)ethanol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 male, 5 female
- Control animals:
- no
Results and discussion
- Preliminary study:
- No preliminary study was conducted.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: 95%CL not applicable
- Mortality:
- One animal died two days after application.
- Clinical signs:
- other: After administration of 2000mg/kg test substance per kg body weight toxic symptons were observed at two animals in form of gasping. One animal recovered one day post application and one showed a toxic sympton in form of an end standing fur. This animal wa
- Gross pathology:
- A necropsy of the animal that died was not possible due to advanced maceration. Necropsy of the remaining animals 14 days after oral application showed no special organ findings.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- An oral LD50 of > 2000 mg/kg body weight was determined when (Z)-2-(8-Heptadecenyl)-4,5-dihydro-1H-imidazole-1-ethanol was administered to male and female Wistar rats with an observation period of 14 days after application.
- Executive summary:
A fixed dose acute oral toxicity study was carried out with (Z)-2-(8-Heptadecenyl)-4,5-dihydro-1H-imidazole-1-ethanol according to OECD Guideline 401 in male and female Wistar rats. A LD50 of > 2000 mg/kg was determined after a observation period of 14 days after application.
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