2'-methoxyacetoacetanilide

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: Important aspects are in line with current OECD guidelines, but study design is restricted due to missing confirmation of negative results by further testing and a different combination of tester strains.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Company guideline similar to OECD 471

Deviations:

no

Principles of method if other than guideline:

Different combination of tester strains

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2'-methoxyacetoacetanilide

EC Number:

202-131-0

EC Name:

2'-methoxyacetoacetanilide

Cas Number:

92-15-9

Molecular formula:

C11H13NO3

IUPAC Name:

N-(2-methoxyphenyl)-3-oxobutanamide

Details on test material:

- Name of test material (as cited in study report): Acetoacet-o-Anisidide

Method

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

rat liver (S9) activation system

Test concentrations with justification for top dose:

Mutagenicity testing was performed at dose levels of 25, 250, 2500, 5000, 10000 µg/plate.

Vehicle / solvent:

solvent used: DMSO

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

solvent DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: Sodium Azid, 9-Aminoacridine, Picrolonic acid, ICR-191, 2-Aminoanthracene

Evaluation criteria:

Six replicate assays of the negative control (solvent) are performed for each strain and a mean is calculated (N). For the test substance the mean of triplicate tests (E) is calculated. In any E>=2N for strains TA-98 and TA-100 or if any E>=3N for strains TA-1535, TA-1537 and TA-1538 and there is evidence of a dose-response relationship, than the test substance will usually be judged as positive in the assay.

Results and discussion

Test results

Species / strain:

other: S. typhimurium TA 1535, TA 1537, TA 1538, 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

Remarks on result:

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

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

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

Summarizing, it can be statecd that Acetoacet-o-anisidide is not mutagenic in this bacterial test system.

Executive summary:

Mutagenicity testing was performed according to a company guideline similar to OECD 471 in tester strains S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100 with and without metabolic activation at dose levels of 25, 250, 2500, 5000, 10000 µg/plate.

The test compound failed to produce a significant response in any of the tester strains, either in the presence or absence of rat liver (S9) activation system. Acetoacet-o-anisidide was therefore judged to be negative in the Salmonella/Microsome Mutagenicity assay.