Ammonium 4-acetoacetylamino-5-methoxy-2-methylbenzenesulphonate

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:

1998

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well performed OECD study with GLP but only 4 strains were tested

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

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:

Ammonium 4-acetoacetylamino-5-methoxy-2-methylbenzenesulphonate

EC Number:

276-769-3

EC Name:

Ammonium 4-acetoacetylamino-5-methoxy-2-methylbenzenesulphonate

Cas Number:

72705-22-7

Molecular formula:

C12H15NO6S.H3N

IUPAC Name:

ammonium 4-acetoacetylamino-5-methoxy-2-methylbenzenesulphonate

Details on test material:

purity: 94.2 % (contains residual water)

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:

rat S 9 (mix)

Test concentrations with justification for top dose:

with and without metabolic activation: 4, 20, 100, 500, 2500, 5000µg/plate

Vehicle / solvent:

double-distilled water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

other: 2-aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation) and preincubation

DURATION
- Exposure duration: 48 hours

NUMBER OF REPLICATIONS: 3

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.

The assay is considered valid if the following criteria are met:
- the solvent control data are within the Iqboratory's normal control range for the spontaneous mutant frequency.
- the positive controls induced increases in the mutation frequency which were both statistically significant and within the laboratory's normal range.

Statistics:

not required for an Ames-test

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:

no cytotoxicity

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'.

Any other information on results incl. tables

The test compound did not precipitate on the plates up to the highest investigated dose of 5000 µg/plate.

The test compound proved to be not toxic to the bacterial strains.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with and wihout metabolic activation

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

Executive summary:

The substancewas tested for mutagenicity with the strains TA 100, TA 1535, TA 1537 and TA 98 of Salmonella typhimurium in an Ames-Test accordiung to OECD guideline 471.

Two independent mutagenicity studies were conducted, each in the absence and in the presence of an Aroclor-induced metabolizing system derived from a rat liver homogenate. For all studies, the compound was dissolved in double-distilled water, and each bacterial strain was exposed to 6 dose levels. Doses for all studies ranged from 4 to 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.

Toxicity: In the mutagenicity experiments toxicity was not observed with and without metabolic activation up to the highest concentration.

Mutagenicity: In the absence and in the presence of the metabolic activation system the test item did not result in relevant increases in the number of revertants in any of the bacterial strains.

Summarizing, it can be stated that AE-Kresidinsulfosaures-NH4-Salz TTR was not mutagenic in this bacterial mutation test at any dose level in either the absence or in the presence of an exogenous metabolic activation.