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EC number: 434-070-2 | CAS number: 268567-32-4
- 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:
- October 27, 1999- October 27, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 434-070-2
- EC Name:
- -
- Cas Number:
- 268567-32-4
- Molecular formula:
- C12 H25 O4 P S2
- IUPAC Name:
- 3-{[bis(2-methylpropoxy)(sulfanylidene)-λ⁵-phosphanyl]sulfanyl}-2-methylpropanoic acid
- Test material form:
- liquid: viscous
Constituent 1
Method
- Target gene:
- All Salmonella Typhimurium strains are histidine auxotrophic mutants. The E. coli strain is a tryptophan auxotrophic mutant.
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: TA1537: his C 3076; rfa-; uvrB-; TA 98: his D 3052; rfa-; uvrB-; TAl535: his G 46; rfa-; uvrB-, TA 100: hisG46;rfa-;uvrB-. The uvrB derivative has a reduction in the activity of an excision repair system.
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- other: The uvrA derivative is deficient in the DNA repair process (excision repair damage).
- Metabolic activation:
- with and without
- Metabolic activation system:
- Mixture of co-factors with S9 fraction of liver from Wistar rats (HanIbm) induced with phenobarbital and beta-naphthoflavone.
- Test concentrations with justification for top dose:
- A preliminary toxicity test was carried out with concentrations of 3, 10, 33, 100, 333, 1000, 2500, 5000 µg/plate suspended in dimethylsulfoxide. From the preliminary test, following concentrations: 0, 33, 100, 333, 1000, 2500, 5000 µg/plate, were used for assessment of mutagenicity, since only minor toxic effects were observed in one of the strains at the maximal concentration and 5000 µg/plate were chosen as maximal concentration. These concentrations were designated as Experiment I of the main mutagenicity test (Plate Incorporation Test).
Since results of Experiment I were negative a second mutagenicity test, designated as Experiment II, was undertaken with following concentrations:
0, 33, 100, 333, 1000, 2500, 5000 µg/plate (Pre-Incubation Test). - Vehicle / solvent:
- - Vehicle: DMSO
The solvent was chosen because of its solubility properties and its relative non-toxicity to the bacteria
No precipitation of the test item occurred up to the highest investigated dose.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- concurrent untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- (without metabolic activation)
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535, TA 100; 10 µg/plate
- Untreated negative controls:
- yes
- Remarks:
- concurrent untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- (without metabolic activation)
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine
- Remarks:
- TA 98, 10 µg/plate; TA 1537, 50 µg/plate
- Untreated negative controls:
- yes
- Remarks:
- concurrent untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- (without metabolic activation)
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- E. coli WP2 uvrA, 5 µL/plate
- Untreated negative controls:
- yes
- Remarks:
- concurrent untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- (with metabolic activation)
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- All S. typhimurium, 2.5 µg/plate; E. coli WP2 uvrA, 10 µg/plate
- Details on test system and experimental conditions:
- The study consisted of a toxicity pre-screen test with and without metabolic activation (plate incorporation, reported as experiment I). Only minor toxic effects were observed. Experiment II was performed as pre-incubation test with and without metabolic activation.
METHOD OF APPLICATION:
Experiment I: plate incorporation test; Experiment II: preincubation test
In each experiment 0.1 mL of the test substance or the vehicle, 0.1 mL of a bacterial culture (in nutrient broth), 0.5 ml S9 mix (with metabolic activation) or S9 mix substitution buffer (without metabolic activation) in 2.0 mL of soft agar was used. In the pre-incubation assay soft agar was added after an incubation period of 1 h at 37 °C. The plates were incubated for about 48 hours at 37 °C in darkness. Each concentration and the controls were tested in triplicate.
DURATION
- Preincubation period: 1 h (Experiment II)
- Expression time: 48 h (Experiment I + II)
DETERMINATION OF CYTOTOXICITY
- Toxicity was assessed as clearing of the bacterial background lawn and/or as reduction of spontaneous revertants. - Evaluation criteria:
- A test item was considered positive if either a dose related increase or a biologically relevant increase for at least one test concentration in the number of revertants was induced.
A test item was considered mutagenic if in the S. Typhimurium strains TA 98, TA 100, and E. coli WP2 uvrA the number of reversions was at least twice as high and in the strains TA 1535 and TA 1537 at least three times higher as compared to the spontaneous reversion rate.
Also, a dose-dependent increase in the number of revertants was regarded as an indication of possibly existing mutagenic potential of the test item regardless whether the highest dose induced the above described enhancement factors or not.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- 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
- Key result
- Species / strain:
- S. typhimurium 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
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A decrease in the number of revertants was seen at concentrations of at least 2500 µg/plate (Experiment II, without S9 mix) and 1000 µg/plate (Experiment II, with S9 mix).
- 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:
- cytotoxicity
- Remarks:
- A decrease in the number of revertants was seen at concentrations of at least 2500 µg/plate (Experiment II, with and without S9 mix) and 5000 µg/plate (Experiment I, with S9 mix).
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- After treatment with CG 37-1586 neither the number of histidine-prototrophic mutants nor the number of tryptophane-prototrophic mutants were increased in comparison to the negative control in any of the experiments. Plates incubated with test article showed normal background growth in either concentration with and without metabolic activation.
Any other information on results incl. tables
Summary of Results
without S9 mix
Concentration | TA 1535 | TA 1537 | TA 98 | TA 100 | WP2 uvrA | |||||
µg/plate | I | II | I | II | I | II | I | II | I | II |
Negative control | 20 | 12 | 10 | 25 | 15 | 20 | 98 | 81 | 44 | 46 |
Solvent control | 12 | 12 | 14 | 23 | 15 | 19 | 93 | 88 | 40 | 55 |
Positive control | 1297 | 615 | 69 | 89 | 440 | 270 | Il49 | 879 | 820 | 273 |
33 | 14 | 8 | 15 | 26 | 12 | 18 | 93 | 82 | 34 | 54 |
100 | 15 | 6 | 15 | 27 | 12 | 17 | 93 | 87 | 37 | 53 |
333 | 16 | 8 | 13 | 16 | 12 | 17 | 101 | 91 | 36 | 54 |
1000 | 17 | 8 | 13 | 18 | 12 | 15 | 94 | 87 | 30 | 48 |
2500 | 18 | 3 | 13 | 10 | 10 | 16 | 92 | 86 | 35 | 34 |
5000 | 6 | 3 | 8 | 3 | 12 | 11 | 66 | 79 | 38 | 35 |
with S9 mix
Concentration | TA 1535 | TA 1537 | TA 98 | TA 100 | WP2 uvrA | |||||
µg/plate | I | II | I | II | I | II | I | II | I | II |
Negative control | 13 | 11 | 7 | 25 | 16 | 23 | 115 | 92 | 49 | 52 |
Solvent control | 9 | 10 | 11 | 18 | 15 | 16 | 101 | 94 | 49 | 44 |
Positive control | 105 | 80 | 56 | 81 | 448 | 694 | 896 | 683 | 204 | 182 |
33 | 9 | 8 | 12 | 22 | 11 | 19 | 98 | 92 | 46 | 71 |
100 | 8 | 7 | 12 | 27 | 16 | 12 | 95 | 87 | 45 | 54 |
333 | 12 | 6 | 9 | 28 | 18 | 16 | 97 | 91 | 45 | 42 |
1000 | 13 | 3 | 10 | 13 | 10 | 12 | 106 | 93 | 37 | 41 |
2500 | 10 | I | 10 | 4 | 9 | 10 | 93 | 83 | 39 | 36 |
5000 | 8 | 4 | 4 | 2 | 7 | 8 | 80 | 78 | 30 | 35 |
I Plate incorporation test
II Preincubation test
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Therefore, the test item is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
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