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EC number: 248-324-3 | CAS number: 27206-35-5
- 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 bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1 July - 1 August 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
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:
- other: EEC Methods for Determination of Toxocity , Annex to Directive 92/69/EEC , Method B14 , Other effects - Mutagenicity : Samonella typhimurium - Reverse Mutation Assay
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: conforms to the guidelines for bacterial mutagenicity testing by the major Japanese Regulatory Authorities including MITI , MOL and MAFF
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (The Department of Health of the Government of the United Kingdom)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Disodium 3,3'-dithiobis[propanesulphonate]
- EC Number:
- 248-324-3
- EC Name:
- Disodium 3,3'-dithiobis[propanesulphonate]
- Cas Number:
- 27206-35-5
- Molecular formula:
- C6H14O6S4.2Na
- IUPAC Name:
- disodium 3,3'-disulfanediyldipropane-1-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): SPS; 1-Propanesulfonic acid, 3,3´-dithiobis-, disodium salt
- Substance type: white powder
- Storage condition of test material: room temperature
Constituent 1
Method
- Target gene:
- his operon (Salmonella strains)
trp operon (Escherichia coli strain)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- incubated in the presence of a induced liver microsomal fraction (S9) prepared from rats
- Test concentrations with justification for top dose:
- First and second experiment : 50 , 150 , 500 , 1500 and 5000 µg/plate with and without metabolic activation
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: sterile distilled water
- Justification for choice of solvent/vehicle: the test material was soluble in water up to 50 mg/ml
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- See -Any other information on materials and methods incl. tables- for details
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: triplicates
NUMBER OF CELLS EVALUATED: 3 plates per dose level , in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: Assessment for numbers of revertant colonies and examination for effects on the growth of the bacterial background lawn .
OTHER: In a range-finding study , five concentrations (50,150,500,1500 and 5000 µg/plate) were assayed in triplicate against each tester strain (with and without S9-mix) , using the direct plate incorporation method . Plates were incunated at 37°C for 48 h . - Evaluation criteria:
- For a substance to be considered positive in this test system , it should have induced a dose-related and statistically significant increase in the revertant count in one or more strains of bacteria in the presence and/or absence of S9 in both experiments at sub-toxic dose levels .
To be considered negative , the number of revertants at each dose level should be less than twofold to that of the vehicle control frequency . - Statistics:
- A statistical analysis of the data was not required to determine the result of the test .
Results and discussion
Test resultsopen allclose all
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: Results for the negative controls (spontaneous mutation rates) were considered to be acceptable .
- Remarks on result:
- other: all strains/cell types tested
Any other information on results incl. tables
Table 1 : Range-finding study
Mean number of revertant colonies per plate (average of 3 plates) | ||||||
With or without S9 -Mix | Test substance concentration (µg/plate) | Base-pair substitution type | Frameshift type | |||
TA 100 | TA 1535 | WP2uvrA- | TA 98 | TA 1537 | ||
- | 0 | 103 | 18 | 20 | 24 | 10 |
- | 50 | 98 | 20 | 18 | 21 | 7 |
- | 150 | 103 | 17 | 16 | 17 | 8 |
- | 500 | 104 | 14 | 19 | 22 | 8 |
- | 1500 | 95 | 19 | 17 | 23 | 9 |
- | 5000 | 105 | 24 | 16 | 23 | 12 |
Positive controls , -S9 | Name | ENNG | ENNG | ENNG | 4NQO | 9AA |
Concentrations (µg/plate) | 3 | 5 | 2 | 0.2 | 80 | |
Mean No. of colonies/plate (average of 3) | 490 | 636 | 653 | 206 | 887 | |
+ | 0 | 107 | 15 | 23 | 30 | 13 |
+ | 50 | 103 | 14 | 23 | 26 | 12 |
+ | 150 | 101 | 15 | 23 | 29 | 13 |
+ | 500 | 103 | 14 | 24 | 24 | 13 |
+ | 1500 | 101 | 18 | 21 | 28 | 13 |
+ | 5000 | 110 | 20 | 23 | 27 | 12 |
Positive controls , +S9 | Name | 2AA | 2AA | 2AA | 2AA | 2AA |
Concentration (µg/plate) | 1 | 2 | 10 | 0.5 | 2 | |
Mean No. of colonies)plate (average of 3) | 1063 | 241 | 822 | 367 | 236 |
ENNG = N-ethyl-N´-nitro-N-nitrosoguanidine
4NQO = 4-nitroquinoline-1 -oxide
9AA = 9-aminoacridine
2AA = 2-aminoanthracene
Table 2 : Main study
Mean number of revertant colonies per plate (average of 3 plates) | ||||||
With or without S9 -Mix | Test substance concentration (µg/plate) | Base-pair substitution type | Frameshift type | |||
TA 100 | TA 1535 | WP2uvrA- | TA 98 | TA 1537 | ||
- | 0 | 86 | 15 | 17 | 18 | 8 |
- | 50 | 81 | 14 | 17 | 15 | 7 |
- | 150 | 88 | 14 | 17 | 19 | 7 |
- | 500 | 82 | 16 | 17 | 20 | 5 |
- | 1500 | 91 | 16 | 17 | 18 | 6 |
- | 5000 | 90 | 15 | 19 | 18 | 9 |
Positive controls , -S9 | Name | ENNG | ENNG | ENNG | 4NQO | 9AA |
Concentrations (µg/plate) | 3 | 5 | 2 | 0.2 | 80 | |
Mean No. of colonies/plate (average of 3) | 477 | 687 | 958 | 256 | 858 | |
+ | 0 | 106 | 16 | 21 | 25 | 11 |
+ | 50 | 103 | 14 | 21 | 30 | 9 |
+ | 150 | 101 | 16 | 24 | 27 | 10 |
+ | 500 | 98 | 16 | 19 | 28 | 7 |
+ | 1500 | 111 | 17 | 21 | 30 | 8 |
+ | 5000 | 94 | 15 | 22 | 26 | 8 |
Positive controls , +S9 | Name | 2AA | 2AA | 2AA | 2AA | 2AA |
Concentration (µg/plate) | 1 | 2 | 10 | 0.5 | 2 | |
Mean No. of colonies)plate (average of 3) | 1126 | 331 | 769 | 422 | 235 |
ENNG = N-ethyl-N´-nitro-N-nitrosoguanidine
4NQO = 4-nitroquinoline-1 -oxide
9AA = 9-aminoacridine
2AA = 2-aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative with metabolic activation
negative without metabolic activation
The study was performed according to the OECD TG471 without deviations and therefore considered to be of the highest quality (reliability Klimisch 1). The validity criteria of the test system are fulfilled. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains , with any dose of the test material , either with or without metabolic activation . The test material was considered to be non-mutagenic under the conditions of this test. - Executive summary:
Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2uvrA- were treated with the test material using the Ames plate incorporation method at five dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolising system (10% liver S9 in standard co-factors). This method conforms to the guidelines for bacterial mutagenicity testing published by the major Japanese Regulatory Authorities including MITI, MHW, MOL and MAFF. lt also meets the requirements of the OECD, EC and USA, EPA (TSCA) guidelines. The dose range was determined in a preliminary toxicity assay and was 50 to 5000 µg/plate in the first experiment. The experiment was repeated on a separate day using the same dose range as experiment 1, fresh cultures of the bacterial strains and fresh test material formulations. The vehicle (sterile distilled water) control plates gave counts of revertant colonies within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with and without metabolic activation. The test material caused no visible reduction in the growth of the bacterial background lawn at any dose level. The test material was, therefore, tested up to the maximum recommended dose level of 5000 µg/plate. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation. The test material was considered to be non-mutagenic under the conditions of this test.
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