Sodium dimethyl 5-sulphonatoisophthalate

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:

2004-03-02 to 2004-03-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

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:

Sodium dimethyl 5-sulphonatoisophthalate

EC Number:

223-578-8

EC Name:

Sodium dimethyl 5-sulphonatoisophthalate

Cas Number:

3965-55-7

Molecular formula:

C10H10O7S.Na

IUPAC Name:

sodium 3,5-bis(methoxycarbonyl)benzenesulfonate

Test material form:

other: solid

Details on test material:

- Name of test material: SIM Ester

Method

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

microsomal enzyme system (S-9 mix) from Aroclor 1254 induced Sprague-Dawley rat liver

Test concentrations with justification for top dose:

75, 200, 600, 1800 and 5000 µg a.i./plate

Vehicle / solvent:

water

Controls

Controls 1

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

with S9-mix, E.coli and S.typhimurium

Controls 2

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

Remarks:

without S9-mix, S. typhimurium (one specific positive control per strain)

Controls 3

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

methylmethanesulfonate

Remarks:

E.coli, without S9-mix

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure/incubation duration: 48-72 hours
NUMBER OF EXPERIMENTS: two independent experiments
NUMBER OF REPLICATES: All dose levels of test article, vehicle control and positiv controls were plated in triplicate.

Evaluation criteria:

For the test article to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain over a minimum of two increasing concentrations of test articles. Data sets for tester strains TA1535 and TA1537 were judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than 3.0-times the mean vehicle control value. Data sets for tester strains TA98, TA100 and WP2 uvr A were iudged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than 2.0-times the mean vehicle control value.

Statistics:

For each replicate plating, the mean and standard deviation of the number of revertants per plate were calculated and are reported.

Results and discussion

Test results

Test results 1

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

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

The results of the Bacterial Reverse Mutation Assay indicate that, under the conditions of this study, the test substance did not cause positive mutagenic response in either the present or the absence of Aroclor-induced rat liver S9.

Executive summary:

Sodium dimethyl 5-sulphonatoisophthalate (SIM-Ester) was tested in the Samonella typhimurium reverse mutation assay (BioReliance, 2004, OECD 471, GLP compliance) in Salmonella typhimurium (TA 1535, TA 1537, TA 98 and TA 100) and Escherichia coli (WP2 uvr A). In an initial toxicity-mutation test, the dose levels tested were 2.5, 7.5, 25, 75, 200, 600, 1800 and 5000 µg per plate. In the confirmatory mutagenicity test, no positive mutagenic response was observed. The dose levels tested were 75, 200, 600, 1800 and 5000 µg per plate. Neither precipitate nor appreciable toxicity was observed. The results of the Bacterial Reverse Mutation Assay indicate that, under the conditions of this study, the test item did not cause a positive mutagenic response in either the presence or absence of Aroclor-induced rat liver S9.