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EC number: 237-249-1 | CAS number: 13708-85-5
- 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:
- 01/2008 to 05/2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant study according to OECD-Guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Disodium phosphonate
- EC Number:
- 237-249-1
- EC Name:
- Disodium phosphonate
- Cas Number:
- 13708-85-5
- Molecular formula:
- Na2HPO3
- IUPAC Name:
- disodium phosphonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Disodium phosphonate (BRÜGGOLEN H10)
- Substance type: inorganic
- Physical state: solid
- Analytical purity: 95%
- Lot/batch No.: 07090801
- Expiration date of the lot/batch: 08.09.2008
- Stability under test conditions:
- Storage condition of test material: room temperature
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium, other: TA97a
- Additional strain / cell type characteristics:
- other: hisD6610, uvrB, pKM 101, rfa
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other: hisD3052, uvrB, pKM 101, rfa
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- other: hisG46, uvrB, pKM 101, rfa
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- other: hisG428, pKM 101, rfa
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- other: HisG46
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9 metabolic activation
- Test concentrations with justification for top dose:
- Experiment I (plate incorporation method): conc.: 5004 / 1501 / 500 / 150 / 50 µg/plate
Experiment II (pre-incubation method): conc.: 5003 / 2502 / 1251 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: [water]
- Justification for choice of solvent/vehicle: test item was completely soluble in water, and water does not have any efects on the viability of the bacteria or the number of spontaneous revertants.
Controlsopen allclose all
- Positive controls:
- yes
- Remarks:
- TA 97a, TA 98 and TA 102
- Positive control substance:
- other: 4-Nitro-1,2-phenylendiamin
- Remarks:
- without metabolic activation system
- Positive controls:
- yes
- Remarks:
- TA 100 and TA 1535
- Positive control substance:
- sodium azide
- Remarks:
- without metabolic activation system
- Positive controls:
- yes
- Remarks:
- TA 98
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with metabolic activation system
- Positive controls:
- yes
- Remarks:
- TA 97a, TA 100, TA 102 and TA 1535
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- with metabolic activation system
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- Preincubation period: 12 hours.
PLATE INCORPORATION METHOD (First Experiment):
- Per strain and dose, four plates with and four plates without S9 mix were used.
10 mL of the test solution of the appropriate concentration were membrane filtrated into sterile vessels.
Top agar basis was melted in a microwave oven, after melting, 10 mL of histidinebiotin-solution 0.5 mMol per 100 mL basis was added and the bottle was placed in the water bath at 45 °C. 0.1 mL of the appropriate solution of the test item were given into a sterile tube. After mixing with 0.1 mL overnight culture of the respective strain and 0.5 mL phosphate buffer (only for treatments without S9) or 0.5 mL S9 mix, 2 mL Top-Agar were added. The mixture was gently vortexed, then poured on a minimal glucose plate and distributed evenly,using a Drigalski spatula. The plates were closed, covered with brown paper and left to harden for a few minutes, then inverted and placed in the dark incubator at 37 °C.
PRE-INCUBATION METHOD (second experiment):
- Per strain and dose, four plates with and four plates without S9 mix were used.
10 mL of the test solution of the appropriate concentration were membrane filtrated into sterile vessels. Top agar basis was melted in a microwave oven, after melting, 10 mL of histidinebiotin- solution 0.5 mMol per 100 mL basis was added and the bottle was placed in the water bath at 45 °C.
0.1 mL of the appropriate solution of the test item were given into a sterile tube. After mixing with 0.1 mL overnight culture of the respective strain, 0.5 mL phosphate buffer (only for treatments without S9) or 0.5 mL S9 mix were added. The mixture was incubated in an incubation chamber at 37°C for 20 minutes. During this time the vessels were aerated through careful shaking. Then 2 mL top agar were added. The mixture was vortexed gently,
then poured on a minimal glucose plate and distributed evenly, using a Drigalski spatula. The plates were closed, covered with brown paper and left to harden for a few minutes, then inverted and placed in the dark incubator at 37 °C.
- Evaluation criteria:
- A test item is considered to have mutagenic potential, if a significant, reproducible increase of revertant colonies per plate (increase factor 2) in at least one strain can be observed. A concentration-related increase over the range tested can also be taken as a sign of mutagenic activity.
- Statistics:
- STATISTICAL METHDODS USED:
The colonies were counted visually, the numbers were recorded. A spreadsheet software (Microsoft Excel®) was used to calculate mean values and standard deviations as well as the increase factor of revertant induction.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: TA 97a, TA 98, TA 100, TA 102 and TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA 97a, TA 98, TA 100, TA 102 and TA 1535
- Metabolic activation:
- 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:
- OBSERVATION
FIRST EXPERIMENT:
• The treatments for the confirmation of the genotype, the sterility control and the determination of the titer did not show any inconsistencies.
• All positive controls (diagnostic mutagens) showed mutagenic effects with and without metabolic activation.
• No signs of toxicity towards the tested strains could be observed:
• The background lawn was visible; the number of revertant colonies was not significantly reduced.
• No significant increase of the number of revertant colonies in the treatments with and without metabolic activation could be observed.
• No concentration-related increase over the tested range was found.
SECOND EXPERIMENT:
• The treatments for the confirmation of the genotype, the sterility control and the determination of the titer did not show any inconsistencies.
• All positive controls showed mutagenic effects with and without metabolic activation.
• No signs of toxicity towards the tested strains could be observed:
• The background lawn was visible; the number of revertant colonies was not significantly reduced.
• No significant increase of the number of revertant colonies in the treatments with and without metabolic activation was observed.
• No concentration-related increase over the tested range was found.
COMPARISON WITH HISTORICAL CONTROL DATA:
The determined values for the spontaneous revertants of the negative controls were in the normal range of the test laboratory historical data of the laboratory (in the first and in the second experiment). - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Remarks: First Experiment
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
The test item is considered to ben non-mutagenic in the bacterial reverse mutation test. - Executive summary:
The test item didn't show mutagenic effects in both effects in both experiments. The number of revertant colonies was not increased in comparison with the spontaneous revertants (solvent only).
Cytotoxicity of the test item was not detected. The background lawn was visible and the number of revertants was not significantly decreased.
Therefore, it can be stated, that under the test conditions, the test item Disodium phosphonate (BRÜGGOLEN H10) is not mutagenic in the Bacterial Reverse Mutation Test using Salmonella typhimurium, strains TA 97a, TA 98, TA 100, TA 102 and TA 1535.
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