Registration Dossier
Registration Dossier
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EC number: 224-030-0 | CAS number: 4170-30-3
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: abstract only (24 march 2010)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- no stability, individual data reported
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Crotonaldehyde
- EC Number:
- 224-030-0
- EC Name:
- Crotonaldehyde
- Cas Number:
- 4170-30-3
- Molecular formula:
- C4H6O
- IUPAC Name:
- but-2-enal
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- oral: unspecified
- Duration of treatment / exposure:
- 13 Weeks
- Frequency of treatment:
- 5 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 2.5, 5, 10, 20, 40 mg/kg bw/day
Basis:
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- no data
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- no data
- Sacrifice and pathology:
- yes
- Other examinations:
- no data
- Statistics:
- no data
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- no data
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 2.5 other: mg/kg
- Sex:
- male/female
- Dose descriptor:
- LOAEL
- Effect level:
- 5 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: compound related mortality
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Compound related mortality was observed in rats of both sexes at 5, 10 , 20 and 40 mg/kg. Mean body weights were significantly decreased for the 40 mg/kg male rats at termination. Compound-related gross necropsy observed in male and female rats were thickened forestomach or nodules. Microscopic lesions were observed in the stomach (including hyperplasia of the forestomach epithelium in the males and females at 10, 20 and 40 mg/kg and forestomach hyperkeratosis, ulcers, moderate necrosis and acute inflammation at 40 mg/kg) and nasal cavity of the rats. Nasal lesions of the rats consisted of acute inflammation in the males as low as 20 mg/kg and females as low as 5 mg/kg.
Applicant's summary and conclusion
- Conclusions:
- NOAEL 2.5 mg/kg bw in males and females
- Executive summary:
Crotonaldehyde was administered for 13 weeks via oral gavage in corn oil to F344 rats (10/sex/group) at does levels of 1, 2.5, 5, 10, 20 and 40 mg/kg. Compound related mortality was observed in rats of both sexes at 5, 10 , 20 and 40 mg/kg. Mean body weights were significantly decreased for the 40 mg/kg male rats at termination. Compound-related gross necropsy observed in male and female rats were thickened forestomach or nodules. Microscopic lesions were observed in the stomach (including hyperplasia of the forestomach epithelium in the males and females at 10, 20 and 40 mg/kg and forestomach hyperkeratosis, ulcers, moderate necrosis and acute inflammation at 40 mg/kg) and nasal cavity of the rats. Nasal lesions of the rats consisted of acute inflammation in the males as low as 20 mg/kg and females as low as 5 mg/kg. The NOAEL was determined to be 2.5 mg/kg bw.
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