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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

- Ames test: negative (+/- S9), (BASF, 1997)

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay
Specific details on test material used for the study:
Batch No . : 16-0259
Degree of purity : 71 .4% trans-2-methylcyclohexylamine and 28 .5% cis-2-methylcyclohexylamine
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
Aroclor induced rat liver S-9 mix)
Test concentrations with justification for top dose:
0; 20 ; 100 ; 500 ; 2500 and 5000 µg/plate
Vehicle / solvent:
DMSO
Untreated negative controls:
yes
Remarks:
Vehicle
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
9-aminoacridine
N-ethyl-N-nitro-N-nitrosoguanidine
other:
Details on test system and experimental conditions:
Individual plate counts, the mean number of revertant colonies per plate and the standard deviations were given for all dose groups as well as for the positive and negative (vehicle) controls in all experiments. In general, six doses of the test substance were tested with a maximum of 5 mg/plate, and triplicate plating was used for all test groups
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Additional information on results:
A bacteriotoxic effect (reduced his' or trp' background growth, decrease in the number of his* or trp' revertants) was observed at doses > 2,500 µg/plate (standard plate test using all tester strains; preincubation test with E . coli) and at doses >1,000 µg/plate (preincubation test using the Salmonella strains) .
Conclusions:
The substance 2-Methylcyclohexylamin was tested for its mutagenic potential based on the ability to induce back mutations in selected loci of several bacterial strains in the Ames test and in the Escherichia coli - reverse mutation assay.

According to the results of the present study, the test substance 2-Methylcyclohexylamin is not mutagenic in the Ames test and in the Escherichia coli - reverse mutation assay under the experimental conditions chosen here .
Executive summary:

Under the experimental conditions chosen here, it is concluded that 2-Methylcyclohexylamini s not a mutagenic test substance in the bacterial reverse mutation test in the absence and the presence of metabolic activation (BASF, 1997).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Ames test:

The substance 2-Methylcyclohexylamin was tested for its mutagenic potential based on the ability to induce back mutations in selected loci of several bacterial strains in the Ames test and in the Escherichia coli - reverse mutation assay.

According to the results of the present study, the test substance 2-Methylcyclohexylamin is not mutagenic in the Ames test and in the Escherichia coli - reverse mutation assay under the experimental conditions chosen here .

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. Negative results were obtained with an Ames-Test of the read-across substance 2-Methylcyclohexylamine.

Therefore no classification for mutagenicity is required according to Regulation (EC) No. 1272/2008.