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EC number: 204-853-1 | CAS number: 127-63-9
- 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

Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets scientific and regulatory standards, but acceptable restrictions (non-GLP test article certification, stability of test article not analysed and no certification of purity and stability
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- yes
- Principles of method if other than guideline:
- Minor modifications
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Diphenyl sulphone
- EC Number:
- 204-853-1
- EC Name:
- Diphenyl sulphone
- Cas Number:
- 127-63-9
- Molecular formula:
- C12H10O2S
- IUPAC Name:
- (benzenesulfonyl)benzene
- Reference substance name:
- 1,1'-sulfonyldibezene
- IUPAC Name:
- 1,1'-sulfonyldibezene
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): diphenyl sulphone
- Substance type: monoconstituent
- Physical state: white crystalline solid
- Analytical purity: stated purity 99.99%
- Impurities (identity and concentrations): see confidential details
- Composition of test material, percentage of components: 99,99% pure
- Isomers composition: not applicable
- Purity test date: see confidential details
- Lot/batch No.: see confidential details
- Expiration date of the lot/batch: see confidential details
- Stability under test conditions: stable under normal storage and test conditions according the Sponsor
- Storage condition of test material: at ambient temperature in the dark until required
- Other: not applicable
Constituent 1
Constituent 2
Method
- Target gene:
- Thymidine kinase TK +/- gene
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- -Type and identity of media: RPMI 1640 with Hepes (GIBCO) supplemented with 4mM L-glutamine (GIBCO), 200 units/mL of penicillin and streptomycin (GIBCO) and 10% horse serum (GIBCO). The serum concentration was dropped to 5% during treatment and raises to 20% whenever the cells were dispensed into microwells.
-Properly maintained: yes
-Periodically checked for Mycoplasma contamination: yes (by ELISA)
-Periodically checked for karyotype stability: no data
-Periodically”cleansed” against high spontaneous background: no data - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- Dose range finding experiment: 125; 63; 31; 16 µg/mL
Experiment 1, +S9 and –S9: 125; 63; 31; 16 µg/mL
Experiment 2, +S9 and –S9: 125; 63; 31; 16 µg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: the test material was found to be soluble in DMSO at all concentrations.
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Remarks:
- -S9:EMS (ethyl methanesulphonate 750 µg/mL); +S9: NDMA( N-nitrosodimethylamine 600 µg/mL)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium (microwell plates)
DURATION
- Preincubation period: 1 hour
- Exposure duration: 4 hours
- Expression time (cells in growth medium): 72 hours
- Selection time (if incubation with a selection agent): 10-12 days
SELECTION AGENT (mutation assays): TFT ( trifluorothymidine)
NUMBER OF REPLICATIONS: duplicate
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency; relative total growth; other: Viability scored by cell growth; mutation scored by colony count - Evaluation criteria:
- Test data from individual experiments were considered valid if:
(a) the spontaneous mutant frequencies in the presence and absence of S9-mix fell within an acceptable range
(b) the positive controls induced unequivocal positive responses.
A positive response in a valid individual experiment is recorded when statistically significant, dose related increases in mutant frequency are observed across a range of toxicity. Such increases in mutant frequency are considered not to be indicative of a positive response if the increases occur only at doses eliciting excessive toxicity, ie <10% survival. These increases must also be associated with increases in the numbers of mutants over those observed with the concurrent solvent control.
A negative result in a valid experiment is obtained when there is no significant dose related increase in mutant frequency compared to the solvent control.
A positive response in an individual experiment must be reproducible for the test sample to be considered positive (ie mutagenic) in this assay. - Statistics:
- A statistical analysis is applied at the discretion of the Study Director in consultation with the Study Statistician. In this study, the data were examined by the Study Statistician and Study Director who considered that statistical analyses were not necessary.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- The highest concentration was based on solubility of the test sample in culture medium, with 125 µg/mL being just in excess of the limit of solubility in the dose range finding study.
- Remarks on result:
- other: strain/cell type: L5178Y cells TK +/-
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1. Summary of Data for Experiment 1
WITHOUT S9 |
WITH S9 |
||||
Conc (µg/mL) |
Mean % Survival |
Mean Mutant Frequency (x10-4) |
Conc (µg/mL) |
Mean % Survival |
Mean Mutant Frequency (x10-4) |
DIPHENYL SULPHONE |
DIPHENYL SULPHONE |
||||
125 |
116 |
2.8 |
125 |
125 |
1.4 |
63 |
120 |
1.9 |
63 |
149 |
1.4 |
31 |
109 |
2.5 |
31 |
124 |
1.4 |
16 |
119 |
2.2 |
16 |
118 |
1.4 |
SOLVENT CONTROL |
SOLVENT CONTROL |
||||
DMSO (10µL/mL) |
100 |
2.3 |
DMSO (10µL/mL) |
100 |
1.9 |
POSITIVE CONTROL |
POSITIVE CONTROL |
||||
EMS (750 µg/mL) |
53 |
9.8 |
NDMA (600 µg/mL) |
100 |
11.4 |
Table 2. Summary of Data for Experiment 2
WITHOUT S9 |
WITH S9 |
||||
Conc (µg/mL) |
Mean % Survival |
Mean Mutant Frequency (x10-4) |
Conc (µg/mL) |
Mean % Survival |
Mean Mutant Frequency (x10-4) |
DIPHENYL SULPHONE |
DIPHENYL SULPHONE |
||||
125 |
93 |
1.4 |
125 |
99 |
0.9 |
63 |
95 |
1.6 |
63 |
107 |
1.1 |
31 |
104 |
1.4 |
31 |
124 |
1.8 |
16 |
105 |
1.1 |
16 |
91 |
1.4 |
SOLVENT CONTROL |
SOLVENT CONTROL |
||||
DMSO (10µL/mL) |
100 |
1.4 |
DMSO (10µL/mL) |
100 |
1.6 |
POSITIVE CONTROL |
POSITIVE CONTROL |
||||
EMS (750 µg/mL) |
30 |
21.6 |
NDMA (600 µg/mL) |
73 |
19.9 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the conditions of this assay, diphenyl sulphone is non-mutagenic to L5178Y TK+/- cells as determined by selection in trifluorothymidine in both the presence and absence of an auxiliary metabolic activation system (S9-mix), when tested up to a concentration just in excess of the limit of solubility in the test medium. - Executive summary:
To assess the mutagenic potential of diphenyl sulphone to mammalian cells, L5178Y TK+/- mouse lymphoma cells were treated in vitro with various concentrations of test sample, both in presence and absence of a rat liver derived auxiliary metabolic activation system (S9-mix). Mutant frequencies were assessed by cell growth in the presence of trifluorothymidine (TFT) after a 72 hour expression time.
Two independent experiments were conducted using a range of concentrations of diphenyl sulphone in the presence and absence of S9-mix. The highest concentration of diphenyl sulphone tested in these two experiments was based on the solubility of the test sample in the culture medium, treatment with diphenyl sulphone at 125µg/mL being just in excess of the limit of solubility. No significant increases in the mutant frequency, compared to the solvent control values, were observed in either experiment in either the presence or absence of S9-mix.
It is therefore concluded that, under the conditions of this assay, diphenyl sulphone is non-mutagenic to L5178Y TK+/- cells in either the presence or absence of S9-mix when tested to a concentration just in excess of the limit of solubility.
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