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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
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

Referenceopen allclose all

Reference Type:
publication
Title:
No information
Author:
National Toxicology Program
Year:
1985
Bibliographic source:
Annual Plan for Fiscal Year 1985, NTP-85-055, March 1985
Reference Type:
publication
Title:
Prediction of chemical carcinogenicity in rodents from in vitro genetic toxicity assays
Author:
Tennant R. W. et al.
Year:
1987
Bibliographic source:
Science, 236, 933-941, 1987
Reference Type:
publication
Title:
Salmonella Mutagenicity Tests: IV. Results From the Testing of 300 Chemicals
Author:
Zeiger E et al.
Year:
1988
Bibliographic source:
Environmental and Molecular Mutagenesis 11, Suppl. 12, 1-158

Materials and methods

Principles of method if other than guideline:
Ames test
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation 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

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 2 batches test:
Lot No. 4-HTP-6
Lot No. Nl 1-26-74-2054

Identity confirmed
Batch 1:
2 impurites:
0.3 %
1.3 %
Batch 2:
0.2 % Impurity

Method

Target gene:
no data
Species / strain
Species / strain / cell type:
other: S. typhimurium TA 97, TA 98, TA 100, TA 1535
Details on mammalian cell type (if applicable):
no data
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S-9 mix
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: sodium azide, 9-aminoacridine, 4-amino-o-phenylenediamin, 2-aminoanthracene
Details on test system and experimental conditions:
IUCLID4 Type: Ames test

Results and discussion

Test results
Key result
Species / strain:
other: S. typhimurium TA 97, TA 98, TA 100, TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity, but tested up to precipitating concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other:

Any other information on results incl. tables

DL-menthol was negative in the Salmonella microsome test

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative
Executive summary:

Three hundred chemicals inclusive DL-menthol were tested for mutagenicity, under code, in Salmonella typhimurium, using a preincubation protocol. All tests were performed in the absence of exogenous metabolie activation, and in the presence of liver S-9 from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters.

DL-menthol was negative in the test.