N,N'-(3,3'-dimethylbiphenyl-4,4'-ylene)di(acetoacetamide)

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

Study period:

1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-(3,3'-dimethylbiphenyl-4,4'-ylene)di(acetoacetamide)

EC Number:

202-111-1

EC Name:

N,N'-(3,3'-dimethylbiphenyl-4,4'-ylene)di(acetoacetamide)

Cas Number:

91-96-3

Molecular formula:

C22H24N2O4

IUPAC Name:

N-{2-methyl-4-[3-methyl-4-(3-oxobutanamido)phenyl]phenyl}-3-oxobutanamide

Details on test material:

Purity: 100 %

Method

Species / strain

Species / strain / cell type:

other: TA 100, TA 1535, TA 1537, TA 1538, TA 98, WP2uvrA

Metabolic activation:

with and without

Metabolic activation system:

rat S9 mix

Test concentrations with justification for top dose:

First experiment: 0, 4, 20, 100, 500, 2500, 10000 µg/plate
Second experiment: 0, 4, 20, 100, 500, 2500, 5000 µg/plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

benzo(a)pyrene

other: N-Methyl-N'-nitro-N-nitrosoguanidine, 2-Aminoanthracene

Details on test system and experimental conditions:

Toxicity test:
The test compound was tested at doses of 4 to 10 000 µg/plate and proved to be not toxic to the bacteria

Results and discussion

Test results

Species / strain:

other: TA 100, TA 1535, TA 1537, TA 1538, TA 98, WP2uvrA

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

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:
negative

It is concluded that the test substance is not mutagenic in these bacterial test systems neither in the absence nor in the presence of an exogenous metabolizing system.

Executive summary:

The substance was tested for mutagenicity with the strains TA 100, TA 1535, TA 1537, TA 1538, TA 98 of Salmonella typhimurium and Escherichia coli WP2uvrA.

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 5 000 µg/plate was used.

Control plates without mutagen showed that the number of spontaneous revertant colonies was similar to that described in the literature. All the positiv 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. 5 000 µg/plate was chosen as top dose level 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 the substance did not result in relevant increases in the number of revertant colonies.

Summarizing, it can be stated that the substance is not mutagenic in these bacterial test systems neither with nor without exogenous metabolic activation at the dose levels investigated.