Reaction product of 2,4-Dinitrotoluene and 2,6-Dinitrotoluene and hydrogen, deaminated

Genetic toxicity: in vitro

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-methylcyclohexylamine

EC Number:

230-277-5

EC Name:

2-methylcyclohexylamine

Cas Number:

7003-32-9

Molecular formula:

C7H15N

IUPAC Name:

2-methylcyclohexanamine

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

Method

Species / strain

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

Controls

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

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Test results 2

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Test results 3

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Test results 4

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Test results 5

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) .

Applicant's summary and conclusion

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).