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EC number: 234-846-9 | CAS number: 12036-35-0
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 August 2016 - 16 March 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:
- Dirhodium trioxide
- EC Number:
- 234-846-9
- EC Name:
- Dirhodium trioxide
- Cas Number:
- 12036-35-0
- Molecular formula:
- Rh2O3
- IUPAC Name:
- Rhodium(III)oxide
- Details on test material:
- Dirhodium trisoxide
Constituent 1
- Specific details on test material used for the study:
- Purity: 81.08% Rhodium metal (equivalent to 100% Rhodium (III) oxide)
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:
- Range-Finder Experiment and 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: the test article formed a homogenous suspension at 50 mg/mL in 0.5% (w/v) methyl cellulose (400 CPS) (0.5% MC). Test article stock suspensions were prepared by suspending Rhodium (III) oxide in 0.5% MC under subdued lighting and with the aid of Silverson mixing and stirring to give the maximum required treatment concentration. Subsequent dilutions were made using 0.5% MC. All test article formulations were stirred continuously throughout dilution and treatment to ensure homogeneity.
- Justification for choice of solvent/vehicle:Preliminary solubility assessments indicated that Rhodium (III) oxide was insoluble in several vehicles compatible with the assay system, including water, ethanol, acetone, dimethylformamide (DMF) and tetrahydrofuran (THF)
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Remarks:
- untreated controls comprised treatments with either 100 mM sodium phosphate buffer (in the Range-Finder Experiment) or purified water (in Mutation Experiments 1 and 2)
- 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 positive controls. Vehicle and untreated controls were tested in quintuplicate (triplicate for experiment 2).
Prepared test suspensions were protected from light and used within approximately 3 hours of initial formulation.
DURATION
As the results of Experiment 1 were negative, treatments in the presence of S-9 in
Experiment 2 included a pre-incubation step. Quantities of test article, vehicle,
untreated or positive control, bacteria and S-9 mix detailed above, were mixed
together and incubated for 20 minutes (see Protocol Deviations, Section 7.5) at
37±1°C, with shaking, before the addition of 2 mL 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 toxicity (and mutation) in strain TA98, TA100 and
TA102. Duplicate plates without and with
S- 9 mix were used for vehicle, untreated and positive controls; single plates were
used for the test article.
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 test article suspension, vehicle, untreated or positive control
• 0.5 mL 10% S-9 mix or buffer solution
followed by rapid mixing and pouring on to 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 > (or equal to) 1.5-fold (in strain TA102), > (or equal to) 2-fold (in strains TA98 and TA100) or > (or equal to) 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. Any observed response was reproducible under the same treatment conditions.
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 either 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 resultsopen allclose all
- Species / strain:
- S. typhimurium 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
- Species / strain:
- S. typhimurium TA 100
- 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
- Species / strain:
- S. typhimurium TA 98
- 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
- Species / strain:
- S. typhimurium TA 1537
- 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
- Species / strain:
- S. typhimurium TA 1535
- 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 Rhodium (III) oxide 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:
Rhodium (III) oxide was assayed 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 Rhodium (III) oxide treatments in this study were performed using suspensions prepared in 0.5% Methyl Cellulose (0.5% MC).
An initial toxicity Range-Finder Experiment was carried out in the absence and in the presence of S-9 in strains TA98, TA100 and TA102 only, using final concentrations of Rhodium (III) oxide up to 5000 μg/plate. No evidence of toxicity was observed.
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.
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 treated as a suspension in this study, and therefore any observations of precipitation are not considered relevant and are not reported.
Vehicle, untreated and positive control treatments were included for all strains in all experiments. The numbers of revertant colonies on vehicle control plates were comparable with acceptable ranges and with the untreated controls, and were elevated by positive control treatments.
Following Rhodium (III) oxide treatments of all the test strains in the absence and presence of S-9 in the mutation experiments, no notable or concentration-related increases in revertant numbers were observed, and none 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 Rhodium (III) oxide mutagenic activity in this assay system.
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