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EC number: 242-899-4 | CAS number: 19231-06-2
- 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
The reported data of a mutagenicity assay according to OECD TG 471 show that under the experimental conditions applied, the test item induce gene mutations by frameshifts in the genome of the investigated Salmonella typhimurium TA1537 strain in the absence and presence of exogenous metabolic activation.
In conclusion, the test item DIMETHOXYDIPHENYL-IODONIUMBROMID has mutagenic activity on the applied Salmonella typhimurium TA1537 under the test conditions used in this study.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 January 2019 - 28 March 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium TA 1537
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- mammalian microsomal enzyme activation mixture (rat liver extract, S9 fraction).
- Test concentrations with justification for top dose:
- 5 to 5000 μg/plate
- Vehicle / solvent:
- In the study two vehicle control groups were used according to the solubility of the test item and the solubility of positive control reference items.
Dimethyl sulfoxide (DMSO) for Test Item, NPD, 9AA and 2AA;
Ultrapure water for SAZ and MMS. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-Nitro-1,2-phenylenediamine, NPD; 2-aminoanthracene, 2AA;
- Details on test system and experimental conditions:
- The exposure was performed according to the 'Plate Incorporation Assay', in which bacteria, test substance (and microsomes) are in contact on the plate without preceding incubation in the liquid state. The number of viable cells in the overnight-cultures is in the range of 1.38 x 10^9 cells per mL.
The plates were incubated at 37 °C for 48 hours and the growth of the bacterial background and the density of revertant colonies was determined.
The test substance was tested without as well as with an external metabolising system (S9-mix). The results were verified by a second, independent experiment. Three plates were used per concentration and per strain for the test substance; 6 for the negative control.
- Evaluation criteria:
- The colony numbers on the controls (untreated, vehicle, positive) and the test item plates were determined (counted manually, evaluated by unaided eye), the mean values and appropriate standard deviations and mutation rates were calculated.
A test item is considered mutagenic if:
- a dose–related increase in the number of revertants occurs and/or;
- a reproducible biologically relevant positive response for at least one of the dose groups occurs in at least one strain with or without metabolic activation.
An increase is considered biologically relevant if:
- in strain Salmonella typhimurium TA100 the number of reversions is at least twice as high as the reversion rate of the vehicle control;
- in strain Salmonella typhimurium TA98, TA1535, TA1537 and Escherichia coli WP2 uvrA the number of reversions is at least three times higher than the reversion rate of the vehicle control.
According to the guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary.
Criteria for a Negative Response:
A test item is considered non-mutagenic if it produces neither a dose-related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups, with or without metabolic activation. - Key result
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- ambiguous
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Genotoxicity:
- ambiguous
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- ambiguous
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- In the performed experiments inhibitory, cytotoxic effect of the test item on bacterial growth was observed. The cytotoxicity was indicated by decreased revertant colony counts (absent revertants or revertants below the corresponding historical control data ranges and/or corresponding vehicle) and/or affected colony development (pinpoint colonies) and/or affected background lawn development (reduced or slightly reduced background lawn). The lowest concentration level where signs of cytotoxicity were noticed was 50 μg/plate (following the plate incorporation procedure in S. typhimurium TA1535 and TA1537; following the pre-incubation procedure in all S. typhimurium strains).
The revertant colony numbers of vehicle control (dimethyl sulfoxide (DMSO)) plates with and without S9 Mix demonstrated the characteristic mean number of spontaneous revertants that was in line with the corresponding historical control data ranges.
The reference mutagen treatments (positive controls) showed the expected, biological relevant increases (more than 3-fold increase) in induced revertant colonies and all of the number of revertants fell in the corresponding historical control ranges (or even were above the historical control data range), thereby meeting the criteria for the positive control in all experimental phases, in all tester strains.
In the initial mutation test, following the plate incorporation procedure, positive results, significant, biologically relevant, dose-related changed revertant colony number increases, revertant colony numbers above the vehicle control data and above the historical control data ranges were obtained in S. typhimurium TA1537 strain in the absence and presence of exogenous metabolic activation (±S9). The biologically relevant increases were adequately confirmed in subsequent experiments. Furthermore, equivocal, borderline positive results, biological relevant revertant colony number increases were noticed in the confirmatory mutation test (pre-incubation test) in E. coli WP2 uvrA, in the absence of exogenous metabolic activation (-S9). These latter increases were not repeated, adequately confirmed, the higher revertant colony numbers remained below the relevant genotoxicological threshold for being positive in the subsequent experiment (repeated pre-incubation test). - Remarks on result:
- other: all strains/cell types tested
- Conclusions:
- The reported data of this mutagenicity assay show that under the experimental conditions applied, the test item induce gene mutations by frameshifts in the genome of the investigated Salmonella typhimurium TA1537 strain in the absence and presence of exogenous metabolic activation.
In conclusion, the test item DIMETHOXYDIPHENYL-IODONIUMBROMID has mutagenic activity on the applied Salmonella typhimurium TA1537 under the test conditions used in this study. - Executive summary:
The test item DIMETHOXYDIPHENYL-IODONIUMBROMID was tested with regard to a potential mutagenic activity using the Bacterial Reverse Mutation Assay.
The initial and confirmatory mutation experiments were carried out using histidine-requiring auxotroph strains of Salmonella typhimurium (Salmonella typhimurium TA98, TA100, TA1535 and TA1537), and the tryptophan-requiring auxotroph strain of Escherichia coli (Escherichia coli WP2 uvrA) in the presence and absence of a post mitochondrial supernatant (±S9) prepared from livers of Phenobarbital/β-naphthoflavone-induced rats. In this study additional (partial), or repeated tests were performed also performed investigating affected, representative strains, only.
For scientific and unforeseen technical reasons, beside the usual procedures (preliminary solubility test, concentration range finding test, initial mutation test and confirmatory mutation test) this study included an additional (partial) plate incorporation test with E. coli WP2 uvrA, an additional (partial) plate incorporation test with S. typhimurium TA1537 and a repeated pre-incubation test with E. coli WP2 uvrA1
Furthermore, the evaluation of the confirmatory mutation test in the case of Salmonella typhimurium strains was not possible (for an unforeseen technical reason), this phase was completed with these strains with the same conditions and concentration levels as the originally proposed procedure, therefore the confirmatory mutation test (pre-incubation test with E. coli WP2 uvrA) and the later performed confirmatory mutation test (pre-incubation test with S. typhimurium strains) phases were mentioned and evaluated as confirmatory mutation tests. .
Based on the results of the solubility test and the concentration range finding test the test item was dissolved in dimethyl sulfoxide (DMSO).
At the concentration choice the solubility and the cytotoxicity of the test item (obtained in the concentration range finding test) were taken into consideration and based on the recommendations of OECD 471 guideline [6] the following concentrations of the test item were prepared and investigated in the initial mutation test:
in S. typhimurium strains: ±S9: 100, 75, 50, 16, 5, 1.6 and 0.5 μg/plate;
in E. coli WP2 uvrA: ±S9: 500, 160, 100, 50, 16, 5 and 1.6 μg/plate.
In the subsequent experiments the above strains were investigated with modified concentration ranges depending on the obtained actual cytotoxicity and mutagenicity results.
The confirmatory mutation tests (pre-incubation tests) were performed with following modified concentration levels:
in S. typhimurium strains: ±S9: 75, 50, 16, 5, 1.6, 0.5 and 0.16 μg/plate;
in E. coli WP2 uvrA: ±S9: 1000, 500, 160, 50, 16, 5 and 1.6 μg/plate.
Based on the noticed test item effects (or missing effects) subsequent additional partial experiments were performed: additional partial plate incorporation test with S. typhimurium TA1537 and E. coli WP2 uvrA, with following concentration levels:
in S. typhimurium TA1537: ±S9: 60, 50, 40, 30, 16, 10 and 5 μg/plate;
in E. coli WP2 uvrA: ±S9: 1000, 750, 500 and 160 μg/plate;
and additional repeated pre-incubation test with E. coli WP2 uvrA, with following concentration levels:
in E. coli WP2 uvrA: ±S9: 1000, 500, 160, 50, 16, 5 and 1.6 μg/plate.
No precipitation of the test item was observed on the plates in the examined bacterial strains at any examined concentration level (±S9 Mix) throughout the study.
In the performed experiments inhibitory, cytotoxic effect of the test item on bacterial growth was observed. The cytotoxicity was indicated by decreased revertant colony counts (absent revertants or revertants below the corresponding historical control data ranges and/or corresponding vehicle) and/or affected colony development (pinpoint colonies) and/or affected background lawn development (reduced or slightly reduced background lawn). The lowest concentration level where signs of cytotoxicity were noticed was 50 μg/plate (following the plate incorporation procedure in S. typhimurium TA1535 and TA1537; following the pre-incubation procedure in all S. typhimurium strains).
The revertant colony numbers of vehicle control (dimethyl sulfoxide (DMSO)) plates with and without S9 Mix demonstrated the characteristic mean number of spontaneous revertants that was in line with the corresponding historical control data ranges.
The reference mutagen treatments (positive controls) showed the expected, biological relevant increases (more than 3-fold increase) in induced revertant colonies and all of the number of revertants fell in the corresponding historical control ranges (or even were above the historical control data range), thereby meeting the criteria for the positive control in all experimental phases, in all tester strains.
In the initial mutation test, following the plate incorporation procedure, positive results, significant, biologically relevant, dose-related changed revertant colony number increases, revertant colony numbers above the vehicle control data and above the historical control data ranges were obtained in S. typhimurium TA1537 strain in the absence and presence of exogenous metabolic activation (±S9). The biologically relevant increases were adequately confirmed in subsequent experiments. Furthermore, equivocal, borderline positive results, biological relevant revertant colony number increases were noticed in the confirmatory mutation test (pre-incubation test) in E. coli WP2 uvrA, in the absence of exogenous metabolic activation (-S9). These latter increases were not repeated, adequately confirmed, the higher revertant colony numbers remained below the relevant genotoxicological threshold for being positive in the subsequent experiment (repeated pre-incubation test).
In summary unequivocal biologically relevant increases in revertant colony numbers were observed in Salmonella typhimurium TA1537 strain following treatment with DIMETHOXYDIPHENYL-IODONIUMBROMID, in the absence and presence of metabolic activation (S9 Mix) in the performed experiments.
The reported data of this mutagenicity assay show that under the experimental conditions applied, the test item induce gene mutations by frameshifts in the genome of the investigated Salmonella typhimurium TA1537 strain in the absence and presence of exogenous metabolic activation.
In conclusion, the test item DIMETHOXYDIPHENYL-IODONIUMBROMID has mutagenic activity on the applied Salmonella typhimurium TA1537 under the test conditions used in this study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Additional information
Justification for classification or non-classification
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