N-(2,5-dimethoxyphenyl)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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed GLP and OECD guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

(This applies even though the guideline was not cited in the report)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N-(2,5-dimethoxyphenyl)acetamide

EC Number:

222-423-1

EC Name:

N-(2,5-dimethoxyphenyl)acetamide

Cas Number:

3467-59-2

Molecular formula:

C10H13NO3

IUPAC Name:

N-(2,5-dimethoxyphenyl)acetamide

Details on test material:

- Name of test material (as cited in study report): 2-Acetamino-1.4-dimethoxybenzol

Method

Species / strain

Species / strain / cell type:

other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100 and E. coli WP2uvrA

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254 induced rat liver S9 mix

Test concentrations with justification for top dose:

Experiment I:
all strains 0, 4, 20, 100, 500, 2500, 10000 µg/plate with and without metabolic activation
Experiment II:
all strains 0, 4, 20, 100, 500, 2500, 5000 µg/plate with and without metabolic activation

Vehicle / solvent:

DMSO

Controls

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 9-Aminoacridine, Sodium azide, 2-Nitrofluorene, N-Methyl-N-nltro-N-nitrosoguanidine, 2-Aminoanthracen, Benzo(a)pyrene

Evaluation criteria:

Positive: significant increase in the number of revertant colonies, or a dose response relationship

Results and discussion

Test results

Species / strain:

other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100 and E. coli WP2uvrA

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

slight toxicity at 10000µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

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

It is concluded that 2-Acetamino-1.4-dimethoxybenzol is not mutagenic in this Ames test.

Executive summary:

2-Acetamino-1.4-dimethoxybenzol was tested for mutagenicity with tester strains TA l00, TA 1535, TA 1537, TA 1538, TA 98 of Salmonella typhimurium and Escherichia coli WP2uvrA according to OECD guideline 471.

 

The mutagenicity studies were conducted in the absence and in the presence of a metabolizing system derived from rat liver homogenate. A dose range of 6 different doses from 4 µg/plate to 10000/5000 µg/plate was used in experiment 1 and 2.

Control plates without mutagen showed that the number of spontaneous revertant colonies was similar to that described in the literature. All the 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 up to 5000 µg/plate. 10000/5000µg/plate was chosen as top dose level for the mutagenicity study in experiment 1 and 2.

 

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 2-Acetamino-1.4-dimethoxybenzol did not result in relevant increases In the number of revertant colonies.

 

Summarizing, it can be stated that 2-Acetamino-1.4-dimethoxybenzol is not mutagenic in these bacterial test systems either with or without exogenous metabolic activation at the dose levels investigated.