N-methylaniline

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

Guideline study reported in Japanese with a summary in English, but no data available concerning the year of performance or reporting.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N-methylaniline

EC Number:

202-870-9

EC Name:

N-methylaniline

Cas Number:

100-61-8

Molecular formula:

C7H9N

IUPAC Name:

N-methylaniline

Method

Target gene:

the amino acid requirement, UV-sensitive mutant and the membrane (rfa) and ampicillin resistance factor (pKM101)

Species / strain

Species / strain 1

Species / strain / cell type:

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

Additional strain / cell type characteristics:

not applicable

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S-9 Mix of Rat liver, induced with phenobarbital and 5,6-benzoflavone

Test concentrations with justification for top dose:

0, 156.3*, 312.5, 625, 1250, 2500, 5000 ug/plate (* only without S9)

Vehicle / solvent:

Dimethylsulphoxide (DMSO)

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

other: -S9 Mix, AF-2 (TA100, WP2, TA98), sodium azide (TA1535) and 9-aminoacridine (TA1537) +S9 Mix, 2-aminoanthracene (all strains)

Details on test system and experimental conditions:

Using the plate method, S9 Mix was tested under conditions with or wthout additives.
Mixed in a small test tube: test substance preparation 0.1 ml, phosphate buffer 0.5 ml (S9 Mix was added in the test S9 Mix 0.5 ml), test bacterial solution and 0.1 ml 2 ml Toppuaga. After mixing, the synthetic medium plates was allowed to harden on the flow.
The plates were cultured for 48 hours at 37℃.
The number of resulting colonies were calculated. The plates were grossly examined or under a stereoscopic microscope.

Evaluation criteria:

The test for five different strains of the bacteria test of at least 1 S9 Mix without additives or additives in the test, the average number of colonies on plates containing the test substance, twice that of vehicle control increased over and if it showed a dose-dependent increase in reproducibility or the substance has mutagenic in the test system (positive) were judged to be.

Statistics:

Not specified.

Results and discussion

Test results

Test results 1

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 5000 ug/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 5000 ug/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Applicant's summary and conclusion

Conclusions:

Interpretation of results: negative.

The test substance proved not to be genotoxic to various bacterial strains in the reverse mutation assay up to concentrations of 5000 ug/plate, which appeared to be cytotoxic by inhibiting bacterial growth.