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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:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with full documentation
Justification for type of information:
Read-across from supporting substance (structural analogue or surrogate)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
no positive controls were used for TA100, TA1535 and TA1537 with metabolic activation. However the number of revertants is very low. Also the number of cells per culture was not specified.
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
The test substance was identified as EXT 8804 p-toluenesulfonic acid.
Molecular weight: 190.2
Appearance was grey-white crystals
Chemical formula: C7H8O3S
Recieved on January 19, 1988 in a plastic bottle
Storage in darkness at room temperature

Method

Target gene:
Histidine independent mutant colonies of Salmonella typhimurium
Species / strain
Species / strain / cell type:
other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100
Additional strain / cell type characteristics:
other: histidine deficient
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 rat liver S9-mix
Test concentrations with justification for top dose:
10, 100, 500, 1000 and 5000 micrograms/plate
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
no
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: sodium azide (without S9 for TA1535 and TA100; 9-aminoacridine without S9 for TA1537; 2-nitrofluorene without S9 for TA1538 and TA98; and 2-aminofluorene with S9 for TA1538 and TA98.
Remarks:
no positive controls were used used for TA100, TA1535 and TA1537 with metabolic activatiion; however the number of revertants is very low

Results and discussion

Test results
Species / strain:
other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not applicable
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

Precipitation concentration was >5000 micrograms per plate

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The test substance is not mutagenic in the AMES Test