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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 publication.

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 in rat by using test chemical
Author:
U.S. National Library of Medicine
Year:
2017
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 study of test chemical in Rat.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name: 1,3,3-Trimethyl-2-oxabicyclo[2.2.2] octane
InChI: 1S/C10H18O/c1-9(2)8-4-6-10(3,11-9)7-5-8/h8H,4-7H2,1-3H3/t8-,10+
Smiles: C[C@@]12CC[C@@H](CC1)C(C)(C)O2
- Name of test material :Cineole
- Molecular formula:C10H18O
- Molecular weight:154.2512 g/mol
- 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
- Fasting period before study: Rats were fasted for approximately 18 hr prior to treatment.
- Diet (e.g. ad libitum): The food was replaced in cages as soon as animals received their respective doses.
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
not specified
Doses:
2480 (Range of 2100-2930mg/kg bw)
No. of animals per sex per dose:
Groups of 10/sex
Control animals:
not specified
Details on study design:
Details on study design
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were maintained under close observation for recording toxic signs and time of death. Such observation was continued until animals appeared normal and showed weight gain.
- Other examinations performed: Animals were observed for general 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:
2 480 mg/kg bw
Based on:
test mat.
95% CL:
2 100 - 2 930
Remarks on result:
other: 50% mortality was observed
Mortality:
50% mortality was observed at 2480 mg/kg bw, within 2hr to 4 days of observation period.
Clinical signs:
Depression, coma on high doses, scrawny appearance for 3-4 days was observed in animals which recovered within 7 days.
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 acute oral LD50 value was considered to be 2480 mg/kg bw, with 95% confidential limit of 2100-2930 mg/kg bw, when male and female Osborne-Mendel rats were treated with test chemical via oral gavage route.
Executive summary:

Acute oral toxicity study of test chemical was conducted in Groups of 10 male and female Osborne-Mendel rats at the concentration of 2480 (Range of 2100-2930mg/kg bw). All animals were maintained under close observation for recording toxic signs and time of death. Such observation was continued until animals appeared normal and showed weight gain. Animals were observed for general clinical signs. LD50's were computed by the method of Litchfield & Wilcoxon (1949). 50% mortality was observed at 2480 mg/kg bw, within 2hr to 4 days of observation period. Depression, coma on high doses, scrawny appearance for 3-4 days was observed in animals which recovered within 7 days. Therefore, LD50 value was considered to be 2480 mg/kg bw, with 95% confidential limit of 2100-2930 mg/kg bw, when male and female Osborne-Mendel rats were treated with test chemical via oral gavage route.