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EC number: 204-783-1 | CAS number: 126-33-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Sulfolane has been examined for genotoxicity in a range of recognized core in vitro assay types and has shown negative results. There are no chemically reactive functional groups in the molecule, and it would not be expected to undergo significant metabolism to any reactive species. The available studies on metabolism support this view (Anderson, et. al., 1976; Roberts and Warwick, 1961). The substance carries no alerts for possible genotoxic activity based on established Structure Activity Relationship (SAR) principles (Tennant and Ashby, 1991).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In vitro
In a study conducted according to the OECD TG 471 (Hatano Research Institute, 1996a), sulfolane did not induce reverse gene mutations in Salmonella typhimurium or E. coli strains in the presence or absence of metabolic activation when tested up to 5,000 μg/plate. Sulfolane was also not mutagenic to Salmonella typhimurium strains with and without metabolic activation when tested at concentrations of 642, 1926, 5778, 17333 and 52000 μg/plate (Hazleton, 1982b).
In a mouse lymphoma assay (Cortina, 1983), the effects of exposure to sulfolane on induction of forward mutations at the thymidine kinase locus were investigated in cultured L5178Y mouse lymphoma cells in the absence and presence of S9 metabolic activation. Sulfolane was considered by the report author to be mutagenic in both the absence and presence of metabolic activation, but the increase in mutant frequency was not dose-dependent and was accompanied by reduced cell viability which was also not dose-dependent. When assessed by the criteria in the draft new OECD Test Guideline: "In vitro mammalian cell gene mutation assays using the thymidine kinase gene", the mutant frequency does not exceed the solvent controls by the global evaluation factor (relevant for the plate method) of 90 x 10⁻⁶. Therefore it is considered the test substance is negative for mutagenicity under the conditions of the test.
Tetrahydrothiophene 1,1-dioxide has been tested for mutagenicity in mouse lymphoma L5178Y cells according to OECD TG 490, and in compliance with GLP (RTC, 2018). No test-substance induced increase in the number of mutations was observed when tested up to limit concentration in the presence and absence of metabolic activation. The result of the first experiment, 3-hour exposure with and without metabolic activation, was confirmed in a second experiment, 24-hour exposure without metabolic activation. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to mammalian cells under the conditions of the study.
Sulfolane, at concentrations up to 5 mg/ml did not result in a consistent increase in the rate of mitotic gene conversion in S. cerevisiae either in the absence or presence of metabolic activation (Shell, 1982). No increased chromosomal aberrations were observed in CHL/IU cells when treated with sulfolane in the absence or presence of metabolic activation (Hatano Research Institute, 1996b). Increased chromosomal damage was not observed in cultured rat liver (RL4) cells when treated with sulfolane (up to 1,000 μg/ml) in the absence of metabolic activation (Shell, 1982).
Sulfolane was considered negative when tested for the induction of sister chromatid exchanges in cultured Chinese hamster ovary (CHO) cells in the presence and absence of metabolic activation (Hazleton, 1983b).
In Vivo
No in vivo genotoxicity studies have been conducted on sulfolane.
However, sulfolane has been tested in a range of recognized core in vitro assay types and has shown negative results for genotoxicity. In vitro bacterial gene mutation studies using S. typhimurium and E. coli have shown no mutagenic activity when sulfolane was tested in the presence and absence of S9 metabolic activation.
Summary, genetic toxicity
In an in vitro cytogenetic assay in mammalian cells (CHL), sulfolane was negative when tested in both the presence and absence of S9 metabolic activation. Sulfolane was considered negative when tested for the induction of sister chromatid exchanges in cultured Chinese hamster ovary (CHO) cells in the presence and absence of metabolic activation. In a mouse lymphoma assay, sulfolane was considered by the study author to be mutagenic in both the absence and presence of metabolic activation. The findings were confounded, however, by reduced cell viability at all dose levels. No dose-response was observed, and the results are considered negative according to current criteria. A recent mouse lymphoma assay, conducted according to OECD 490, concluded that sulfolane did not induce mutation at the TK locus of L5178Y mouse lymphoma cells in vitro in the absence or presence of S9 metabolic activation, under the conditions of the assay.There are no functional groups in the molecule, and it would not be expected to undergo significant metabolism to any reactive species. It carries no alerts for possible genotoxic activity based on established Structure Activity Relationship (SAR) principles (Tennant and Ashby, 1991).
Andersen, M.E., Jones, R.A., Kurlansik, L., Mehl, R.G., and Jenkins, L.J., Jr. (1976) Sulfolane-induced convulsions in rodents. Res. Commun. Chem. Pathol. Pharmacol. 15: 571-580.
Roberts, J.J., and Warwick, G.P. (1961) The mode of action of alkylating agents – III The formation of 3-hydroxytetrahydrothiophene-1;1-dioxide from 1:4-dimethylsulphonyloxybutane (Myleran), S-β-L-alanyltetrahydrothiophenium mesylate, tetrahydrothiophene and tetrahydrothiophene-1:1-dioxide in the rat, rabbit and mouse. Biochem. Pharmacol. 6: 217-227.
Tennant and Ashby, 1991: Ashby, J. and Tennant, R. W. Definitive relationships among chemical structure, carcinogenicity and mutagenicity for 301 chemicals tested by the U.S. NTP. Mutation Research, 257, (1991) 229-306.
Justification for classification or non-classification
Sulfolane has been examined for genotoxicity in a range of recognized core in vitro assay types and has shown negative results. Therefore, sulfolane does not warrant classification as a mutagen under CLP.
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