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EC number: 215-223-0 | CAS number: 1314-15-4
- 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:
- 17 May 2018 - 3 August 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Platinum dioxide
- EC Number:
- 215-223-0
- EC Name:
- Platinum dioxide
- Cas Number:
- 1314-15-4
- Molecular formula:
- O2Pt
- IUPAC Name:
- Platinum dioxide
- Details on test material:
- Platinum dioxide
CAS# 1314-15-4
Constituent 1
- Specific details on test material used for the study:
- Purity: 100% PtO2x0.7H2O or 94.5% PtO2 (based on platinum content of 81.17%)
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 derived from Aroclor 1254-treated male Sprague-Dawley rats
- Test concentrations with justification for top dose:
- Mutation Experiment 1 (with and without S9)
5, 16, 50,160, 500, 1600, 5000 ug/plate
Mutation Experiment 2 (with and without S9)
51.2, 128, 320, 800, 2000, 5000 ug/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Formulations in 1% Methyl Cellulose (1% MC) at concentrations equivalent to at least 100 mg/mL provided stable suspensions, and were used for the formulations and subsequent dilutions of test article in this study. Test article stock formulations were prepared by suspending Platinum dioxide,hydrate under subdued lighting in 1% MC with the aid of Silverson mixing and stirring (where required), to give the maximum required treatment concentration. Subsequent dilutions were made using 1% MC. The test article suspensions were protected from light and used within approximately 5 hours of initial formulation.
- Justification for choice of solvent/vehicle: Preliminary solubility data indicated that Platinum dioxide,hydrate was not soluble in a variety of standard vehicles that are compatible with the assay system for this study, including Water, Ethanol, Acetone, Tetrahydrofuran, Dimethylformamide and NMethyl-2-pyrrolidone. Formulations in 1% Methyl Cellulose (1% MC) at
concentrations equivalent to at least 100 mg/mL provided stable suspensions, and were used for the formulations and subsequent dilutions of test article in this study
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- mitomycin C
- other: 2-aminoanthracene
- Remarks:
- 2NF for TA98 (-S9); NaN3 for TA100 and TA1535 (-S9); AAC for TA1537 (-S9); MMC for TA102 (-S9); BaP for TA98 (+S9); AAN for TA100, TA1535, TA1537 and TA102 (+S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- In agar (plate incorporation); preincubation (for experiment 2 in the presence of S9).
- 0.1 mL volume additions of test article suspension were used for all treatments (positive controls were treated using 0.05 mL volume additions)
Triplicate plates for test substance and vehicle&positive controls.
Prepared test suspensions were protected from light and used within approximately 5 hours of initial formulation.
DURATION
As the results of Experiment 1 were equivocal, treatments in the presence of S-9 in Experiment 2 included a pre-incubation step. Quantities of test article, vehicle control
solution (reduced to 0.05 mL) or positive control, bacteria and S-9 mix detailed above, were mixed together and incubated for 20 minutes at 37±1°C, with shaking,
before the addition of 2 mL of supplemented molten agar at 45±1°C. Plating of these treatments then proceeded as for the normal plate-incorporation procedure.
DETERMINATION OF CYTOTOXICITY
The test item was tested for for evidence of toxicity to the background lawn using the 5 tester strains in experiment 1, using triplicate platings.
These platings were achieved by the following sequence of
additions to 2 mL of molten agar at 45±1°C:
• 0.1 mL bacterial culture
• 0.1 mL of testarticle suspension/vehicle control or 0.05 mL of positive control
• 0.5 mL 10% S-9 mix or buffer solution
followed by rapid mixing and pouring on to Vogel-Bonner E agar plates. When set, the plates were inverted and incubated at 37±1°C protected from light for 3 days.
Following incubation, these plates were examined for evidence of toxicity to the background lawn and, where possible, revertant colonies were counted. - Evaluation criteria:
- Data were considered acceptable if the vehicle control counts fell within the calculated historical control ranges and the positive control plate counts were comparable with the historical control ranges.
The assay was considered to be valid if all the following criteria were met:
1. The vehicle control counts fell within the laboratory’s historical control ranges
2. The positive control chemicals induced increases in revertant numbers of ≥1.5-fold (in strain TA102), ≥2-fold (in strains TA98 and TA100) or ≥3-fold (in strains TA1535 and TA1537) the concurrent vehicle control confirming discrimination between different strains, and an active S-9 preparation.
For valid data, the test article was considered to be mutagenic if:
1. A concentration related increase in revertant numbers was ≥1.5-fold (in strain TA102), ≥2-fold (in strains TA98 and TA100) or ≥3-fold (in strains TA1535 and TA1537) the concurrent vehicle control values
2. The positive trend/effects described above were reproducible.
The test article was considered positive in this assay if both of the above criteria were met.
The test article was considered negative in this assay if neither of the above criteria were met. - Statistics:
- Individual plate counts were recorded separately and the mean and standard deviation of the plate counts for each treatment were determined. Control counts were
compared with the laboratory’s historical control ranges.
The presence or otherwise of a concentration response was checked by non-statistical analysis, up to limiting levels (for example toxicity, precipitation or 5000 μg/plate).
However, adequate interpretation of biological relevance was of critical importance.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- In a guideline Ames test, it was concluded that Platinum dioxide did not induce mutation in five histidine requiring strains (TA98, TA100, TA1535, TA1537 and TA102) of Salmonella typhimurium when tested at concentrations up to 5000 μg/plate for each strain, in the absence and in the presence of a rat liver metabolic activation system (S-9).
- Executive summary:
Platinum dioxide ,hydrate was as sayed for mutation in five histidine-requiring strains (TA98, TA100, TA1535, TA1537 and TA102) of Salmonella typhimurium, both in the absence and in the presence of metabolic activation by an Aroclor 1254-induced rat liver post-mitochondrial fraction (S-9), in two separate experiments. As no vehicle could be identified that would dissolve the test article and was compatible with the assay system, all Platinum dioxide,hydrate treatments in this study were performed using suspensions prepared in 1% Methyl Cellulose (1% MC).
The same concentrations were retained for treatments of all the tester strains in Experiment 1 in the absence and in the presence of S-9. Following these treatments, no evidence of toxicity was observed.
Mutation Experiment 1 treatments of all the tester strains were performed in the absence and in the presence of S-9, using final concentrations of Platinum
dioxide,hydrate at 5, 16, 50, 160, 500, 1600 and 5000 μg/plate. Following these treatments, no evidence of toxicity was observed.
Experiment 2 treatments of all the tester strains were performed in the absence and in the presence of S-9. The maximum test concentration of 5000 μg/plate was retained for all strains. Narrowed concentration intervals were employed covering the ranges 51.2 - 5000 μg/plate. In addition, all treatments in the presence of S-9 were further modified by the inclusion of a preincubation step. Following these treatments, no clear evidence of toxicity was observed.
The test article was formulated and treated as a suspension in this study, and therefore any observations of precipitation are not considered relevant and are not reported.
Vehicle and positive control treatments were included for all strains in both experiments. The mean numbers of revertant colonies fell within acceptable ranges for vehicle control treatments, and were elevated by positive control treatments.
Following Platinum dioxide,hydrate treatments of all the tester strains in the absence and presence of S-9, only the Experiment 1 treatments of strains TA98 and TA100 in the presence of S-9 provided any notable increases in revertant numbers. Although these increases approached (in strain TA98) or exceeded (in strain TA100) 2-fold the concurrent vehicle control level, and appeared to provide some evidence of a concentration-relationship as they each occurred at the highest treatment concentration, in both cases the increases were almost entirely attributable to a single elevated replicate plate count. As no comparable increases were observed following either the plate incorporation or pre-incubation methodology treatments of these
strains in the presence of S-9 in Experiment 2, it was considered that the single elevated plate counts with these strain treatments in Experiment 1 were not a true compound-related effect. As no other strain treatments provided any increases in revertant numbers that were ≥1.5-fold (in strain TA102), ≥2-fold (in strains TA98 or TA100) or ≥3-fold (in strains TA1535 or TA1537) the concurrent vehicle control, this study was considered therefore to have provided no evidence of any Platinum dioxide,hydrate mutagenic activity in this assay system.
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