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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
other: Read across from supporting substance
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
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, one strain is missing

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

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 resultsopen allclose all
Species / strain:
E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
not determined
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
not applicable
Untreated negative controls validity:
not applicable
Positive controls validity:
not applicable
Species / strain:
S. typhimurium 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
Species / strain:
S. typhimurium TA 98
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
Species / strain:
S. typhimurium TA 1537
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
Species / strain:
S. typhimurium TA 1535
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