Dimethyl 2-aminoterephthalate

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 version using a different combination of test strains

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1195

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl 2-aminoterephthalate

EC Number:

226-364-2

EC Name:

Dimethyl 2-aminoterephthalate

Cas Number:

5372-81-6

Molecular formula:

C10H11NO4

IUPAC Name:

1,4-dimethyl 2-aminobenzene-1,4-dicarboxylate

Constituent 2

Reference substance name:

dimethyl-2-aminoterephthalate

IUPAC Name:

dimethyl-2-aminoterephthalate

Details on test material:

- Name of test material (as cited in study report): Aminoterephthalsäuredimethylester

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:

0, 4, 20, 100, 500, 2500 and 5000 µg/plate with and without S9 mix.
Two independent experiments were performed, 3 plates were counted at each concentration in each experiment.

Vehicle / solvent:

On the day of the experiment the test substance was dissolved in DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: Sodium-azide, 9-Aminoacridine, 2-Nitrofluorene, 2-Aminoanthracene

Evaluation criteria:

Criteria for a positive response:

Test article is considered mutagen if biologically relevant increase in number of revertants exceeding the threshold of 2fold the colony count of the vehicle control is found or if it induces a dose-related increase in the number of revertants over the vehicle control in at least two to three concentrations at complete bacterial background lawn.

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:

cytotoxicity

Remarks:

Cytotoxic effects were observed at 5000 µg/plate without S9 mix in TA100, TA1535 and TA1537

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Visible precipitation was observed at 2500 µg/plate and higher.

Toxicity: The test compound proved to be not toxic to the bacterial strains at concentrations below 5000 µg/plate.

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

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

Executive summary:

Aminoterephthalsäuredimethylester was tested for mutagenicity with the strains TA 100, TA 1535, TA 1537 and TA 98 of Salmonella typhimurium according to OECD 471. The mutagenicity studies were conducted in the absence and in the presence of a metabolizing system derived from rat liver homogenate. The test substance was dissolved in DMSO and a dose range of 6 different doses from 4 microgram/plate to 5000 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 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 at concentrations below 5000 microgram/plate.

5000 microgram/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 Aminoterephthalsäuredimethylester did not result in relevant increases in the number of revertant colonies. Summarizing, it can be stated that Aminoterephthalsäuredimethylester is not mutagenic in these bacterial test systems either with or without exogenous metabolic activation at the dose levels investigated.