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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to
Guideline:
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
Deviations:
no
Principles of method if other than guideline:
No further information available.
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tetrahydrothiophene-1,1-dioxide
- Analytical purity: 99.9%
- Storage condition of test material: kept at room temperature until use

Method

Target gene:
No information is available.
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
other: histidine-dependent auxotrophic mutants
Species / strain / cell type:
E. coli WP2 uvr A
Additional strain / cell type characteristics:
other: tryptophan-dependent mutant
Metabolic activation:
with and without
Metabolic activation system:
S9 from phenobarbital and 5,6-benzoflavone induced rat liver
Test concentrations with justification for top dose:
313, 625, 1250 and 5000 µg/plate (with and without S9 mix)
Vehicle / solvent:
No information is available.
Controls
Negative solvent / vehicle controls:
yes
Remarks:
deionized water
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
with S9
Details on test system and experimental conditions:
- Plate incorporation method.
Evaluation criteria:
No data.
Statistics:
No statistical analysis performed.

Results and discussion

Test resultsopen allclose all
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:
no cytotoxicity
Remarks:
(but tested up to limit concentrations)
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
(but tested up to limit concentrations)
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
No further information in available.

Any other information on results incl. tables

No evidence of mutagenic activity was seen at any concentration of sulfolane.

The concurrent positive controls demonstrated the sensitivity of the assay and the metabolising activity of the liver preparations.

Applicant's summary and conclusion

Conclusions:
Sulfolane showed no evidence of mutagenic activity in this bacterial system under the test conditions employed. Positive control compounds gave the expected results demonstrating that the studies were robust.
Executive summary:

In an in vitro assessment of the mutagenic potential of sulfolane, histidine-dependent auxotrophic mutants of Salmonella typhimurium, strains TA1535, TA1537, TA98 and TA100, and a tryptophan-dependent mutant of Escherichia coli, strain WP2 uvrA, were exposed to sulfolane, diluted in deionized water. Deionized water was used as a negative control.

Two independent mutation tests were performed in the presence and absence of liver preparations (S9 mix) from rats treated with phenobarbital and 5,6-benzoflavone. Both tests were standard plate incorporation assays.

Concentrations of sulfolane up to 5000 µg/plate were tested. No signs of toxicity were observed towards the tester strains in either mutation test.

No evidence of mutagenic activity was seen at any concentration of sulfolane in either mutation test.

The concurrent positive controls demonstrated the sensitivity of the assay and the metabolising activity of the liver preparations.

It is concluded that sulfolane showed no evidence of mutagenic activity in this bacterial system under the test conditions employed.