Registration Dossier

Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

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

Constituent 1
Chemical structure
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
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.

Categories Display