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Toxicological information

Acute Toxicity: oral

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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:
1964
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:
2018
Bibliographic source:
ChemIDplus

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
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

Test animals

Species:
rat
Strain:
Osborne-Mendel
Sex:
male/female
Details on test animals 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.