5-Diazo-2,4,6(1H, 3H, 5H)-pyrimidinetrione

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: according to OECD TG and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Qualifier:

according 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:

5-Diazo-2,4,6(1H, 3H, 5H)-pyrimidinetrione

EC Number:

608-591-2

Cas Number:

31221-06-4

Molecular formula:

C4H2N4O3

IUPAC Name:

5-Diazo-2,4,6(1H, 3H, 5H)-pyrimidinetrione

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:

S9-mix was made from the livers of at least 6 male Sprague-Dawley rats . For enzyme induction the animals received a single intraperitoneal injection of Aroclor 1254 dissolved in corn oil 5 days prior to sacrifice.

Test concentrations with justification for top dose:

+/- S9-mix: 0, 50, 160, 500, 1600, 5000 µg/plate in DMSO

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 2-AA, Na-azide, MMC, 2-NF, 4-NPDA

Details on test system and experimental conditions:

plate incorporation assay according to the respective guideline

Evaluation criteria:

A reproducible and dowe-related increase in mutant countts of at least one strain is consedered to be a positive result.
For TA1535 ,TA100, TA1537 and TA100 and TA98 this increase should be about twice that of negative controls. For TA102 an increase of about 100 mutants should be reached.
Otherwise, the result is evaluated as negative.
In case of questionable results, investigations should continue, possibly with mdifications, until a final evaluation is possible.

Statistics:

no data

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:

positive

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Based on clear positive results in a first series of trials in the presence and in the absence of the metabolic activation system in all test strains used, no second series of trials was performed . This is in accordance with the respective OECD Guideline.

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):
positive

Executive summary:

Diazobarbitursäure was initially invvestigated according to OECD TG 471 using the Salmonella/microsome plate incorporation methodology and Salmonella typhimurium TA1535, TA100, TA1537, TA98 and TA102. The test item was dissolved in DMSO, in doses of up to and including 5000 µg/plate. In all ofthe salmonella typhimurium strains a biologically relevant increase was found in the mutant count compared to the corresponding negative control. Due to these results Diazobarbitursäure has to be regarded as mutagenic in the Salmonella/Microsome test.