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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Collection of bacetrial mutagenicity test results

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
not specified
Principles of method if other than guideline:
Six test substance concentrations; with and without metabolic activation; positive and negative controls; 3 replicates; application using preincubation assay with a 20 minute timeframe.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Target gene:
Histidine independent mutant colonies of Salmonella typhimurium
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA97, TA98, TA100, TA1535
Additional strain / cell type characteristics:
other: histidine deficient
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced S9 from rat and hanster
Test concentrations with justification for top dose:
100, 333, 1000, 3333, 6667 (without activation) and 10000 (with activation) micrograms per plate
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
no
True negative controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene; 4-nitro-o-phenylenediamine; sodium azide, 9-aminoacridine
Remarks:
DMSO as true negative control

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium, other: TA97, TA98, TA100, TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity, but tested up to precipitating concentrations
Vehicle controls validity:
not applicable
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested

Any other information on results incl. tables

Precipitation concentration 10,000 micrograms per liter

Applicant's summary and conclusion

Conclusions:
Benzenesulphonic acid is not cytotoxic or mutagenic in the Ames bacterial reverse mutation assay