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Toxicological information

Genetic toxicity: in vivo

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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:
1993
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
Name:
Unnamed
Type:
Constituent
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
Sex:
male
Genotoxicity:
negative
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.