2-amino-N-cyclohexyl-N-methylbenzylamine

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-amino-N-cyclohexyl-N-methylbenzylamine

EC Number:

260-701-4

EC Name:

2-amino-N-cyclohexyl-N-methylbenzylamine

Cas Number:

57365-08-9

Molecular formula:

C14H22N2

IUPAC Name:

2-amino-N-cyclohexyl-N-methylbenzylamine

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Test concentrations with justification for top dose:

3.16, 10.0, 31.6, 100, 316, 1000, 2500 and 5000 µg/plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Remarks:

dest. water

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

Positive controls:

yes

Positive control substance:

sodium azide

methylmethanesulfonate

other: 4-nitro-o-phenylene-diamine CAS: 99-56-9, 2-aminoanthracene CAS: 613-13-8

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

In experiment I toxic effects of the test item were noted in tester strain TA 98 at a concentration of 5000 µg/plate (without metabolic activation) and at concentrations of 2500 µg/plate and higher (with metabolic activation). In tester strain TA 100 toxic effects of the test item were observed at concentrations of 1000 µg/plate and higher (without metabolic activation) and at concentrations of 2500 µg/plate and higher (with metabolic activation). In tester strain TA 1535 toxic effects of the test item were seen at concentrations of 2500 µg/plate and higher (without metabolic activation) and at a concentration of 5000 µg/plate (with metabolic activation). In tester strain TA 1537 toxic effects of the test item was observed at a concentration of 5000 µg/plate (with metabolic activation). In tester strain TA 102 toxic effects of the test item were noted at concentrations of 2500 µg/plate and higher (with and without metabolic activation.
In experiment II toxic effects of the test item were observed in tester strain TA 98 at concentrations of 2500 µg/plate and higher (with and without metabolic activation). In tester strain TA 100 toxic effects of the test item were noted at concentrations of 1000 µg/plate and higher (without metabolic activation) and at concentrations of 2500 µg/plate and higher (with metabolic activation). In tester strains TA 1535 and TA 1537 toxic effects of the test item were noted at concentrations of 1000 µg/plate and higher (with and without metabolic activation). In tester strain TA 102 toxic effects of the test item were observed at concentrations of 1000 µg/plate and higher (without metabolic activation) and at a concentration of 5000 µg/plate (with metabolic activation).

Applicant's summary and conclusion

Conclusions:

In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, 2-Amino-N-cyclohexyl-N-methylbenzylamine did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used.
Therefore, 2-Amino-N-cyclohexyl-N-methylbenzylamine is considered to be non-mutagenic in this bacterial reverse mutation assay

Executive summary:

The test item 2-Amino-N-cyclohexyl-N-methylbenzylamine was investigated for its potential to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) usingSalmonella typhimuriumstrains TA 98, TA 100, TA 1535, TA 1537 and TA 102.

In two independent experiments several concentrations of the test item were used. Each assay was conductedwithandwithoutmetabolic activation. The concentrations, including the controls, were tested in triplicate. The following concentrations of the test item were prepared and used in the experiments:

3.16, 10.0, 31.6, 100, 316, 1000, 2500 and 5000 µg/plate

No precipitation of the test item was observed in any tester strain used in experiment I and II (withandwithoutmetabolic activation).

Toxic effects of the test item were noted in all tester strains evaluated in experiment I and II.