Sodium toluene-4-sulphonate

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:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Protocols and results reviewed and accepted by the National Toxicology Program's Board of Scientific Counselor's Technical Reports Review Subcommittee, USA National Institutes of Health

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OTS 798.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)

Deviations:

not specified

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Sodium xylenesulfonate

IUPAC Name:

Sodium xylenesulfonate

Details on test material:

- Name of test material (as cited in study report): sodium xylene sulfonate- Molecular formula (if other than submission substance): no data- Molecular weight (if other than submission substance): no data- Substance type: organic- Physical state: powder- Analytical purity: 65% (11.5% ortho, 38% meta, 15.5% para)- Impurities (identity and concentrations): not identified from NMR Spectrum provided- Composition of test material, percentage of components: (11.5% ortho, 38% meta, 15.5% para)- Purity test date: February 13, 1986- Lot/batch No.: RO92085 / 03- Expiration date of the lot/batch: no data- Stability under test conditions: stable - Storage condition of test material: glass bottles with Teflon lined caps or double bagged in metal drums at room temperature in the dark- Other:

Method

Target gene:

Histidine independent mutant colonies of Salmonella typhimurium

Species / strain

Species / strain / cell type:

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

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

rat S9 and hamster S9

Test concentrations with justification for top dose:

100, 333, 1000, 3333 and 10000 microgram active ingredient/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: buffer

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene, sodium azide, 4-niro-o-phenylenediamine, nad 9-aminoacridine

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)DURATION- Preincubation period: no data- Exposure duration: 2 days- Expression time (cells in growth medium): - Selection time (if incubation with a selection agent): - Fixation time (start of exposure up to fixation or harvest of cells): SELECTION AGENT (mutation assays): SPINDLE INHIBITOR (cytogenetic assays): STAIN (for cytogenetic assays): NUMBER OF REPLICATIONS: triplicates and entire trial repeated onceNUMBER OF CELLS EVALUATED: histidine independent coloniesDETERMINATION OF CYTOTOXICITY - Method: mitotic index; cloning efficiency; relative total growth; other:OTHER EXAMINATIONS: - Determination of polyploidy: - Determination of endoreplication: - Other: OTHER:

Evaluation criteria:

positive response defined as reproducible, dose-related increase in histidine-independent (revertant) colonies in any one strain/activation combination. An equivocal response is defined as an increase in revertants that is not dose-related, is not reproducible, or is of insufficient magnitude to support a determination of mutagenicity.

Results and discussion

Test results

Key result

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:

not determined

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):negativeTest substance is not mutagenic