Dimethyl 2-nitroterephthalate

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:

2000

Report date:

2000

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-nitroterephthalate

EC Number:

226-134-1

EC Name:

Dimethyl 2-nitroterephthalate

Cas Number:

5292-45-5

Molecular formula:

C10H9NO6

IUPAC Name:

dimethyl 2-nitroterephthalate

Details on test material:

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

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254 (R) induced rat liver S9 mix

Test concentrations with justification for top dose:

Experiment 1a: plate incorporation test:
a: without metabolic activation: 50, 160,500, 1600 and 5000 µg/plate
b: with metabolic activation: 50, 160, 500, 1600 and 5000 µg/plate

Experiment 1b: plate incorporation test:
a: without metabolic activation: 0.5, 1.6, 5, 16, 50 and 160 µg/plate

Experiment 2: preincubation test:
a: without metabolic activation: 16, 50, 160,500, 1600 and 5000 µg/plate
b: with metabolic activation: 0.5, 1.6, 5, 16, 50 and 160 µg/plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Remarks:

untreated

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: without metabolic activation: sodium-azide for strain TA 100 and TA 1535, 9-aminoacridine for strain TA 1537, 2-nitrofluorene for strain TA 98, Mitomycin C for strain TA 102, with metabolic activation: 2-aminoanthracene for all strains

Evaluation criteria:

A test compound is classified as mutagenic if it has either of the following effects:

a) it 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) it 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 compound at complete bacterial background lawn.

If the test substance does not achieve either of the above criteria, it is considered to show no evidence of mutagenic activity in this system.

Statistics:

not required

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

without metabolic activation at concentrations of 160 µg/plate and above, with metabolic activation at the dose level of 5000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

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 with and without metabolic activation

The results lead to the conclusion that Nitro-DMT is not mutagenic in these bacterial test systems either in the absence or in the presence of an exogenous metabolizing system.

Executive summary:

Nitro-DMT was tested for mutagenicity with the strains TA 100, TA 1535, TA 1537, TA 98 and TA 102 of Salmonella typhimurium at concentrations up to 5000µg/plate according to OECD TG 471. Two independent mutagenicity studies were conducted (one plate incorporation test and one preincubation test), each in the absence and in the presence of a metabolizing system derived from a rat liver homogenate.

Cytotoxicity was observed without metabolic activation at concentrations of 160 µg/plate and above, and with metabolic activation at the dose level of 5000 µg/plate.

Control plates without mutagen showed that the number of spontaneous revertant colonies was within the laboratory's historical control range. All the positive control compounds showed the expected increase in the number of revertant colonies.

In the absence and in the presence of the metabolic activation system Nitro-DMT did not result in relevant increases in the number of revertants in any of the bacterial strains.

Summarizing, it can be stated that Nitro-DMT was not mutagenic in this bacterial mutation test at any dose level either in the absence or presence of an exogenous metabolic activation.