Registration Dossier
Registration Dossier
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EC number: 246-495-9 | CAS number: 24851-98-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Does not meet important criteria of today standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: US FHSA Guidelines
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Methyl 3-oxo-2-pentylcyclopentaneacetate
- EC Number:
- 246-495-9
- EC Name:
- Methyl 3-oxo-2-pentylcyclopentaneacetate
- Cas Number:
- 24851-98-7
- Molecular formula:
- C13H22O3
- IUPAC Name:
- methyl 3-oxo-2-pentylcyclopentaneacetate
- Details on test material:
- - Name of test material (as cited in study report): hedione
- Substance type: pure active substance
- Analytical purity: ~100%
- isomers composition: ca. 10 cis- and 90 % trans- isomers
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Fasting period before study: 16-18 h prior to testing
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Pure substance employed (dose provided: 5g/kg)
- Doses:
- 5 g/kg
- No. of animals per sex per dose:
- 10 (sex not specified)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Frequently the day of the test and daily thereafter
- Necropsy of survivors performed: none (not required by FHSA guideline)
- Other examinations performed: lethality, clinical signs - Statistics:
- Not Applicable (limit test)
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- approximate LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no 95% CL
- Mortality:
- none
- Clinical signs:
- other: none
- Gross pathology:
- not performed (not required by FHSA)
Applicant's summary and conclusion
- Interpretation of results:
- other: non toxic
- Remarks:
- Criteria used for interpretation of results: other: US-FHSA
- Executive summary:
Acute Oral Toxicity of the test material was determined according to the U.S. -Federal Hazardous Substance Act (FHSA) Guidelines. Ten Wistar rats fasted for a period of 16 -18 hours were dosed orally with the test substance at a level of 5 g/kg bw. They were returned to their cage and given food and water ad libitum. Observations for mortality and pharmaceuticological effects were made frequently on the day of the test and daily therafter for 14 days. No necropsies were performed at termination of the study.
No death occured during the study. No relevant clinical signs were observed. The LD50 was estimated to be greater than 5.0 mg/kg.
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