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EC number: 209-909-9 | CAS number: 597-82-0
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan - Feb 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Jul 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- Aug 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- O,O,O-triphenyl phosphorothioate
- EC Number:
- 209-909-9
- EC Name:
- O,O,O-triphenyl phosphorothioate
- Cas Number:
- 597-82-0
- Molecular formula:
- C18H15O3PS
- IUPAC Name:
- O,O,O-triphenyl thiophosphate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: test substance was weighed and topped up with DMSO and shaken thoroughly
- Final dilution of a dissolved solid, stock liquid or gel: further concentrations were diluted from the stock solution according to the planned doses
FORM AS APPLIED IN THE TEST: solution
Method
- Target gene:
- his and trp
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:
- Type and composition of metabolic activation system:
- source of S9 : rat liver
- method of preparation of S9 mix: At least 5 male Wistar rats [Crl:WI(Han)] received 80 mg/kg b.w. phenobarbital i.p. and β-naphthoflavone orally each on three consecutive days. Twenty-four hours after the last administration, rats were sacrificed, and livers were prepared
using sterile solvents and glassware at a temperature of +4°C. Livers were weighed and
washed in a weight-equivalent volume of a 150 mM KCl solution and homogenized in three
volumes of KCl solution. After centrifugation of the homogenate at 9000 x g for 10 minutes at
+4°C, 5 mL portions of the supernatant (S9 fraction) were stored at -70°C to -80°C.
- concentration or volume of S9 mix and S9 in the final culture medium : 0.5 ml
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability): yes - Test concentrations with justification for top dose:
- - 1st and second experiment: 0; 33; 100; 333; 1000; 2500 and 5000 μg/plate
In agreement with the recommendations of current guidelines 5 mg/plate or 5 μL/plate were generally selected as maximum test dose at least in the 1st Experiment. However, this maximum dose was tested even in the case of relatively insoluble test compounds to detect possible mutagenic impurities. Furthermore, doses > 5 mg/plate or > 5 μL/plate might also be tested in repeat experiments for further clarification/substantiation. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Due to the insolubility of the test substance in water, DMSO was used as vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available
Controls
- Untreated negative controls:
- yes
- Remarks:
- omitting tester strains
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- other: • +S9: 2-aminoanthracene (2.5 µg/plate for S. typhimurium, 60 µg/plate for E. coli) • -S9: N-methyl-N'-nitro-N-nitrosoguanidine (5 µg/plate for TA 1535, TA 100) • -S9: 4-nitro-o-phenylenediamine (10 µg/plate for TA 98)
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments : 2
- 1st experiment: Standard plate test with and without S9 mix
- 2nd experiment: Preincubation test with and without S9 mix
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): approximately 10^9 cells per mL
- Test method: preincubation and plate incorporation
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: 20 minutes
- Exposure duration/duration of treatment: 48-72 h
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: background growth inhibition; decrease in the number of revertants (factor ≤ 0.6)
METHODS FOR MEASUREMENTS OF GENOTOXICIY :
- Individual plate counts, the mean number of revertant colonies per plate and the standard deviations were given for all dose groups as well as for the positive and negative (vehicle) controls in all experiments.
OTHER:
- Precipitation - Evaluation criteria:
- Assessment criteria
The test substance was considered positive in this assay if the following criteria were met:
• A dose-related and reproducible increase in the number of revertant colonies, i.e. at least doubling (bacteria strains with high spontaneous mutation rate, like TA 98, TA 100 and E.coli WP2 uvrA) or tripling (bacteria strains with low spontaneous mutation rate, like TA 1535 and TA 1537) of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system.
A test substance was generally considered non-mutagenic in this test if:
• The number of revertants for all tester strains were within the range of the historical negative control data under all experimental conditions in at least two experiments carried out independently of each other
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at and above 2500 µg/plate (slight decrease in the number of his+ revertants) at plate incorporation test only (1st experiment)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at and above 2500 µg/plate and at 5000 µg/plate with and without S9, respectively.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 1000 µg/plate and 5000 µg/plate without S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- 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
- True negative controls validity:
- not applicable
- 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
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Solubility:
Test substance precipitation was observed at and above 2500 μg/plate with and without S9 mix.TEST-SPECIFIC CONFOUNDING FACTORS
Cytotoxicity:
A weak bacteriotoxic effect (slight decrease in the number of his+ revertants) was observed only using tester strain TA 1535 with and without S9 mix at and above 2500 μg/plate. In the preincubation assay bacteriotoxicity (slight decrease in the number of his+ revertants) was occasionally observed depending on the strain and test conditions at and above 1000 μg/plate.
Any other information on results incl. tables
Experimental Results:
Standard Plate Test:
Mean revertants per plate | ||||||||||
Strain | TA 1535 | TA 100 | TA 1537 | TA 98 | WP2uvrA | |||||
Dose (µg/plate) | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 |
DMSO | 18.7 | 18.0 | 115.0 | 116.0 | 9.0 | 11.0 | 22.3 | 32.7 | 31.3 | 30.0 |
33 | 15.0 | 19.0 | 114.3 | 123.0 | 6.7 | 14.3 | 21.0 | 28.7 | 26.3 | 30.3 |
100 | 14.0 | 19.0 | 111.7 | 117.7 | 7.0 | 7.7 | 19.0 | 35.3 | 26.7 | 34.0 |
333 | 15.0 | 15.3 | 119.3 | 129.3 | 10.7 | 12.0 | 16.0 | 30.3 | 31.7 | 28.0 |
1000 | 21.7 | 12.3 | 125.7 | 120.3 | 6.7 | 12.7 | 19.0 | 33.7 | 24.3 | 30.3 |
2500 | 10.7 | 12.0 | 109.7 | 112.3 | 8.3 | 8.7 | 17.3 | 27.0 | 22.7 | 27.3 |
5000 | 11.7 | 9.7 | 101.7 | 112.3 | 8.0 | 7.7 | 16.7 | 23.3 | 22.3 | 24.0 |
positive control | 5536.3 | 284.0 | 3517.7 | 2227.0 | 943.3 | 162.7 | 871.3 | 2520.3 | 1276.7 | 226.3 |
Preincubation test:
Mean revertants per plate | ||||||||||
Strain | TA 1535 | TA 100 | TA 1537 | TA 98 | WP2uvrA | |||||
Dose (µg/plate) | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 |
DMSO | 13.7 | 12.3 | 114.7 | 115.0 | 9.3 | 8.3 | 27.7 | 28.3 | 30.0 | 29.7 |
33 | 14.0 | 9.3 | 111.7 | 104.0 | 6.3 | 6.7 | 23.0 | 22.7 | 25.7 | 26.3 |
100 | 15.7 | 8.7 | 109.3 | 109.7 | 11.0 | 8.0 | 22.3 | 29.0 | 29.0 | 25.0 |
333 | 12.7 | 9.3 | 108.3 | 108.3 | 9.7 | 9.7 | 22.7 | 32.0 | 32.0 | 26.0 |
1000 | 12.7 | 14.7 | 109.3 | 104.3 | 11.0 | 10.7 | 17.0 | 29.3 | 26.0 | 28.0 |
2600 | 15.7 | 10.3 | 102.7 | 104.3 | 5.7 | 6.0 | 18.3 | 26.7 | 26.0 | 24.3 |
5200 | 11.0 | 9.0 | 101.3 | 98.0 | 4.0 | 4.7 | 16.3 | 23.0 | 24.0 | 20.7 |
positive control | 4773.0 | 126.7 | 3041.3 | 1307.7 | 756.0 | 105.0 | 876.0 | 1128.0 | 647.0 | 240.3 |
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions of this study, the test substance is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.
- Executive summary:
The test substance was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium and Escherichia coli, in a reverse mutation assay. Strains used were TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA. The dose range was 33 μg - 5000 μg/plate (SPT) 33 μg - 5000 μg/plate (PIT). Test conditions chosen were the standard plate test (SPT) and preincubation test (PIT) both with and without metabolic activation (liver S9 mix from induced rats). Precipitation of the test substance was observed at and above 2500 μg/plate with and without S9 mix. A weak bacteriotoxic effect was occasionally observed depending on the strain and test conditions at and above 1000 μg/plate. A relevant increase in the number of his+ or trp+ revertants (factor ≥ 2: TA 100, TA 98 and E.coli WP2 uvrA or factor ≥ 3: TA 1535 and TA 1537) was not observed in the standard plate test or in the preincubation test without S9 mix or after the addition of a metabolizing system. Under the experimental conditions of this study, the test substance is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.
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