N-(2-methoxy-5-methylphenyl)acetamide

Genetic toxicity: in vitro

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: Performed according to a previous guideline using a different combination of tester strains.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

adopted May 26, 1983

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N-(2-methoxy-5-methylphenyl)acetamide

EC Number:

230-157-2

EC Name:

N-(2-methoxy-5-methylphenyl)acetamide

Cas Number:

6962-44-3

Molecular formula:

C10H13NO2

IUPAC Name:

N-(2-methoxy-5-methylphenyl)acetamide

Details on test material:

- Name of test material (as cited in study report): Acetkresidin 34 TTRS, (N-(2-methoxy-5-methylphenyl)acetamide)

Method

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254 induced rat liver S9 mix

Test concentrations with justification for top dose:

First experiment: 0, 4, 20, 100, 500, 2500, 10000 µg/plate with and without metabolic activation
Second experiment: 0, 4, 20, 100, 500, 2500, 5000 µg/plate with and without metabolic activation

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: without S9: sodium-azide; 9-Aminoacridin; 2-Nitrofluorene; with S9: 2-Aminoanthracen

Details on test system and experimental conditions:

Two independent experiments.
Three plates per dose

Evaluation criteria:

A test article is classified mutagenic if either a) or b) is fulfilled:
a) a test article produces at least a 2-fold increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control at complete bacterial background lawn
b) a test article induces a dose related increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control in at least two to three concentrations of the test article at complete bacterial background lawn.

The test results must be reproducible

Statistics:

A statistical analysis of the data is not mandatory

Results and discussion

Test results

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:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

The test compound was tested at doses of 4 to 10 000 microgram/plate and proved to be not toxic to the bacterial strains.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

The test article was not mutagenic under the experimental conditions used.

Executive summary:

Acetkresidin 34 TTRS was tested for mutagenicity with the strains TA 100, TA 1535, TA 1537, TA 98 of Salmonella typhimurium according to OECD 471.

The mutagenicity studies were performed in the absence and in the presence of a metabolizing system derived from rat liver homogenate. A dose range of 7 different doses from 4 microgram/plate to 10000 microgram/plate was used.

Control plates without mutagen showed that the number of spontaneous revertant colonies was similiar to that described in the literature. All positive control compounds gave the expected increase in the number of revertant colonies.

Toxicity: The test compound proved to be not toxic to the bacterial strains.

10000 (first experiment) and 5000 microgram/plate (second experiment) were chosen as top dose levels for the mutagenicity study.

Mutagenicity: In the absence of the metabolic activation system the test compound did not show a dose dependent increase in the number of revertants in any of the bacterial strains. Also in the presence of a metabolic activation system, treatment of the cells with Acetkresidin 34 TTRS did not result in relevant increases in the number of revertant colonies.

Summarizing it can be stated that Acetkresidin 34 TTRS is not mutagenic in these bacterial test systems either with or without exogenous metabolic activation at the dose levels investigated.