Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 204-783-1 | CAS number: 126-33-0
Genetic toxicity: in vitro
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:
- 1 996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- 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 substance name:
- Tetrahydrothiophene 1,1-dioxide
- EC Number:
- 204-783-1
- EC Name:
- Tetrahydrothiophene 1,1-dioxide
- Cas Number:
- 126-33-0
- Molecular formula:
- C4H8O2S
- IUPAC Name:
- 1λ⁶-thiolane-1,1-dione
- Reference substance name:
- Sulfolane
- IUPAC Name:
- Sulfolane
- Reference substance name:
- Tetrahydrothiophene-1,1-dioxide
- IUPAC Name:
- Tetrahydrothiophene-1,1-dioxide
- 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
Constituent 1
Constituent 2
Constituent 3
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:
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
