(2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one

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 publication.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

I. Acute Oral Toxicity

Author:

Jenner et al.

Year:

1964

Bibliographic source:

Food and Cosmetics Toxicology

Reference 2

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

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

Test material information

Constituent 1

Reference substance name:

Cineole

EC Number:

207-431-5

EC Name:

Cineole

Cas Number:

470-82-6

Molecular formula:

C10H18O

IUPAC Name:

1,3,3-trimethyl-2-oxabicyclo[2.2.2]octane

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 or test system and environmental conditions:

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:

- 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:

other: Depression, coma on high doses, scrawny appearance for 3-4 days was observed in animals which recovered within 7 days.

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.