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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

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

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: other: S. typhimurium TA 97, TA 98, TA 100, TA 1535

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 metabolic 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.