Benzenesulfonic acid, 4-[(1,3-dioxobutyl)amino]-, sodium salt (1:1)

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:

2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed OECD study with GLP

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)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Potassium 4-acetoacetylaminobenzenesulphonate

EC Number:

274-569-0

EC Name:

Potassium 4-acetoacetylaminobenzenesulphonate

Cas Number:

70321-85-6

IUPAC Name:

potassium 4-(acetoacetylamino)benzenesulfonate

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:

rat S9 mix

Test concentrations with justification for top dose:

For both experiments:
313, 625, 1250, 2500, 5000 µg/plate

Vehicle / solvent:

sterile distilled water

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

cumene hydroperoxide

other: 2-Aminoanthracene, DMSO

Evaluation criteria:

For the test item to be considered mutagenic, two-fold (or more) increases in mean revertant numbers must be observed at two consecutive dose levels or at the highest practcable dose level only. In addition there must be evidence of a dose-response relationship showing increasing numbers of mutant colonies with increasing dose levels. The effect must be reproduced in an independent experiment.

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:

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 (migrated information):
negative without metabolic activation
negative without metabolic activation

It is concluded that the potassium salt of the N-acetoacetyl sulphanilic acid does not induce reverse mutations in this Ames Test. It is expected that the the same is with the sodium salt since the propeties of it are rather the same.

Executive summary:

The potassium salt of the N-acetoacetyl sulphanilic acid was tested for mutagenic activity in an Ames Test with the strains TA 1535, TA1537, TA98, TA100 and TA102. Test item solutions were prepared using sterile distilled water. Experiments were performed in the absence and presence of metabolic activation using liver S9 fraction from rats pre-treated with phenobarbitone and beta-naphthoflavone.

No toxicity was observed when thetest item was assayed at a maximum dose level of 5000 µg/plate.

Both experiments, a) using the plate incorporation method and b) with inclusion of a pre.incubation step were performed with the following concentrations: 5000, 2500, 1250, 625 and 313 µg/plate.

The test item did not induce two-fold increases in the number of revertant colonies at any dose level, in any tester strain, in the presence and absence of S9 metabolism.