trans-menthone

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

Reference

Reference 1

Reference Type:

publication

Title:

Acute oral toxicity study of test chemical was performed in rodents.

Author:

D. L. J. Opdyke

Year:

1976

Bibliographic source:

Food and Cosmetics Toxicology

Reference 2

Reference Type:

secondary source

Title:

Acute oral toxicity study of test chemical was performed in rodents.

Author:

Food and Drug Administration

Year:

1985

Bibliographic source:

National Technical Information Service

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Acute oral toxicity of (2R,5S)-5-methyl-2-(propan-2-yl)cyclohexan-1-one (CAS no.: 89-80-5) in rats

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

trans-menthone

EC Number:

201-941-1

EC Name:

trans-menthone

Cas Number:

89-80-5

Molecular formula:

C10H18O

IUPAC Name:

2-isopropyl-5-methylcyclohexanone

Details on test material:

- IUPAC Name: (2R,5S)-5-methyl-2-(propan-2-yl)cyclohexan-1-one- Common Name: Menthone- InChI: 1S/C10H18O/c1-7(2)9-5-4-8(3)6-10(9)11/h7-9H,4-6H2,1-3H3- Smiles:C1([C@@H](CC[C@@H](C1)C)C (C)C)=O- Molecular formula:C10H18O - Molecular weight :154.2512 g/mole- Substance type:Organic

Specific details on test material used for the study:

- IUPAC Name: (2R,5S)-5-methyl-2-(propan-2-yl)cyclohexan-1-one- Common Name: Menthone- InChI: 1S/C10H18O/c1-7(2)9-5-4-8(3)6-10(9)11/h7-9H,4-6H2,1-3H3- Smiles:C1([C@@H](CC[C@@H](C1)C)C (C)C)=O- Molecular formula:C10H18O - Molecular weight :154.2512 g/mole- Substance type: Organic- Physical state: Liquid

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

not specified

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

not specified

Doses:

Range of 1820-2620 mg/kg bw

No. of animals per sex per dose:

groups of 10 M and 10 F

Control animals:

not specified

Details on study design:

not specified

Statistics:

not specified

Results and discussion

Preliminary study:

not specified

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 950 mg/kg bw

Based on:

test mat.

95% CL:

1 820 - 2 620

Remarks on result:

other: 50% mortality observed

Mortality:

50% mortality observed at 1950 mg/kg bw.

Clinical signs:

other: not specified

Gross pathology:

not specified

Other findings:

not specified

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

LD50 was considered to be 1950 mg/kg bw, with 95% confidence limit of 1820-2620 mg/kg bw, when rats were treated with (2R,5S)-5-methyl-2-(propan-2-yl)cyclohexan-1-one (CAS no.: 89-80-5) via oral gavage route.

Executive summary:

The acute oral toxicity study was conducted by using (2R,5S)-5-methyl-2-(propan-2-yl)cyclohexan-1-one (CAS no.: 89-80-5) in groups of 10 male and 10 female rats at the dose concentration range between 1820-2620 mg/kg bw.50% mortality observed at1950 mg/kg bw. Therefore, LD50 was considered to be 1950 mg/kg bw, with 95% confidence limit of 1820-2620 mg/kg bw, when rats were treated with (2R,5S)-5-methyl-2-(propan-2-yl)cyclohexan-1-one (CAS no.: 89-80-5) via oral gavage route.