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Registration Dossier
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EC number: 201-939-0 | CAS number: 89-78-1
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: sufficient documented for evaluation
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of a three-exposure mouse|bone marrow micronucleus protocol: results with 49 chemicals
- Author:
- Shelby MD, Erexson GL, Hook GJ, Tice RR
- Year:
- 1 993
- Bibliographic source:
- Environ. Mol. Mutagen. 21, 160-179 (1993)
Materials and methods
- Principles of method if other than guideline:
- DL-menthol was tested in a mouse bone marrow micronucleus test that employed three daily exposures by intraperitoneal injection. Bone marrow samples were obtained 24 hr following the final exposure.
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Menthol
- EC Number:
- 201-939-0
- EC Name:
- Menthol
- Cas Number:
- 89-78-1
- Molecular formula:
- C10H20O
- IUPAC Name:
- 2-isopropyl-5-methylcyclohexanol
Constituent 1
- Specific details on test material used for the study:
- DL-Menthol, CAS 15356-70-4 = CAS 89-78-1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male
Administration / exposure
- Route of administration:
- intraperitoneal
- Duration of treatment / exposure:
- one injection per day on 3 consecutive days
- Frequency of treatment:
- one injection per day
- Post exposure period:
- 24 hours following the final exposure
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 250, 500, 1000 mg/kg
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5 or 6 animals/dose
- Control animals:
- yes, concurrent vehicle
Examinations
- Tissues and cell types examined:
- mouse bone marrow
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- 3/6 (number of animals surviving tratment over number of animals treated)
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
Any other information on results incl. tables
The initial test was negative to 1000 mg/kg and was not
repeated.
Survival: 0 mg/kg 5/5
250 mg/kg 5/5
500 mg/kg 5/5
1000 mg/kg 3/6
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
- Executive summary:
Menthol was tested in a mouse bone marrow micronucleus test that employed three daily exposures by intraperitoneal injection. Bone marrow samples were obtained 24 hr following final exposure. Menthol was negative in this test.
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