Registration Dossier
Registration Dossier
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EC number: 214-494-2 | CAS number: 1135-66-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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 peer-reviewed journal.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- I. Acute Oral Toxicity
- Author:
- Jenner et al.
- Year:
- 1 964
- Bibliographic source:
- Food and Cosmetics Toxicology
- Reference Type:
- other: authoritative database
- Title:
- Acute oral toxicity by using test chemical
- Author:
- U.S. National Library of Medicine
- Year:
- 2 018
- Bibliographic source:
- ChemIDplus
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Acute Oral toxicity test was carried out to study the effects of given test chemical on rats.
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
Test material
- Reference substance name:
- (1S)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-one
- EC Number:
- 225-160-0
- EC Name:
- (1S)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-one
- Cas Number:
- 4695-62-9
- Molecular formula:
- C10H16O
- IUPAC Name:
- (1S)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-one
- Test material form:
- liquid
- Details on test material:
- - Name of test material (IUPAC name): (1S)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-one
- Common name: (+)-Fenchone
- Molecular formula: C10H16O
- Molecular weight: 152.2354 g/mol
- Smiles notation: C[C@]12CC[C@H](C1)C(C)(C)C2=O
- InChl: 1S/C10H16O/c1-9(2)7-4-5-10(3,6-7)8(9)11/h7H,4-6H2,1-3H3/t7-,10+/m1/s1
- Substance type: Organic
- Physical State: Liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Details on test animal
TEST ANIMALS
- Age at study initiation: young and adult rats
- Fasting period before study: approximately 18 hr
- Diet (e.g. ad libitum):diet was provided ad libitum
- Water (e.g. ad libitum): water was provided ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- not specified
- Doses:
- 6160 mg/kg bw
- No. of animals per sex per dose:
- Groups of 10 males and 10 females
- Control animals:
- not specified
- Details on study design:
- Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: All animals were maintained under close observation for recording toxic signs and time of death.
- Other examinations performed: clinical signs - Statistics:
- LD50'S were computed by the method of Litchfield & Wilcoxon (1949).
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 6 160 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 4 400 - 8 630
- Remarks on result:
- other: 50% mortality was observed
- Mortality:
- Death time was observed from 4 hours to 9 days
- Clinical signs:
- Clinical signs like Depression, scrawny appearance, porphyrin-like deposit around eyes and nose for a week after treatment were observed.
- Body weight:
- not specified
- Gross pathology:
- not specified
- Other findings:
- not specified
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Conclusions:
- The lethal concentration (LD50) value for acute oral toxicity test was considered to be 6160 mg/kg bw (95% confidence limits: 4400-8630 mg/kg bw), when group of 10 male and female Osborne-Mendel rats were treated with the given test chemical orally via gavage.
- Executive summary:
Acute oral toxicity study was performed in group of 10 male and female Osborne-Mendel rats using test chemical. Death time was observed from 4 hours to 9 days. Clinical signs like Depression, scrawny appearance, porphyrin-like deposit around eyes and nose for a week after treatment were observed. Hence, LD50 value was considered to be 6160 mg/kg bw (95% confidence limits:4400-8630 mg/kg bw), when groups of 10 male and female Osborne-Mendel rats were treated with the given test chemical orally via gavage.
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