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EC number: 264-713-0 | CAS number: 64164-17-6
- 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:
- 08 November 2013 - 10 February 2014
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Well-conducted study performed in accordance with OECD guidelines (with acceptable minor deviations) and to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Vehicle revertant count (mean and one individual count in strain TA102, expt 2) with S9 was outside 99% CI. Marginal difference. Data considered valid. Not considered to affect overall interpretation of study findings or study integrity.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Diammonium sodium hexakis(nitrito-N)rhodate
- EC Number:
- 264-713-0
- EC Name:
- Diammonium sodium hexakis(nitrito-N)rhodate
- Cas Number:
- 64164-17-6
- Molecular formula:
- H4N.1/2N6O12Rh.1/2Na
- IUPAC Name:
- Diammonium sodium hexakis(nitro-N)rhodate
- Reference substance name:
- Rhodium nitrite salt
- IUPAC Name:
- Rhodium nitrite salt
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Diammonium sodium hexakis(nitrito-N)rhodate
- Substance type: technical product
- Physical state: solid (green powder)
- Analytical purity: assumed 100% for experimental suspension formulation
- Impurities (identity and concentrations): traces of platinum (0.01%), ruthenium (0.073%), iridium (0.044%), silver (0.016%); traces of other metals (iron, nickel, bismuth, copper, tellurium, chromium, magnesium) documented in the study report's certificate of analysis
- Composition of test material, percentage of components: Rhodium 16.63%; sodium 3.88%
- Purity test date: 01 April 2014
- Lot/batch No.:RHL 653
- Expiration date of the lot/batch: 03 June 2015. The expiry date of the test article was based on two years from the production date of the material. As far as the manufacturer is aware, no degradation/aging is expected in any long term time frame however there is no analytical data available to confirm this.
- Stability under test conditions: test article stability in the vehicle was not determined in this study; fresh preparations were routinely employed.
- Storage condition of test material: 15-25 degrees C, protected from light
Constituent 1
Constituent 2
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)
160
300
625
1250
2500
5000 ug/plate
Mutation Experiment 2 Additional work in strain TA100 (without S9)
500
1000
2000
3000
4000
5000 ug/plate
Mutation Experiment 2 Additional work in strain TA1537 (without S9)
100
250
750
1000
1250
2500
5000 ug/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: test material was applied in a homogenous suspension: approximately 10.00 mg/mL in 1% methylcellulose (1% MC (high viscosity)). To ensure homogeneity was maintained throughout treatment each formulation was stirred continuously using a magnetic stirrer.
- Justification for choice of solvent/vehicle: the test material was insoluble in several commonly used solvents including dimethylformamide (DMF), ethanol, water for irrigation (purified water), tetrahydrofuran (THF), acetone and acetonitrile
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Remarks:
- As 1% MC (high viscosity) is not commonly used as a vehicle in this laboratory, untreated control treatments (UTC) comprising 100 mM sodium phosphate buffer (pH 7.4) were also included
- 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).
- 0.5 mL volume additions of test article solution were used for all treatments (except experiment 2 pre-incubation treatments for positive control): 0.05 mL due to the vehicle (DMSO) employed.
Triplicate plates for test substance and positive controls. Vehicle and untreated controls were tested in quintuplicate.
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 or control solution, bacteria and S 9 mix, were mixed together and incubated for 20 minutes at 37±1 degreesC, with shaking, before the addition of 2.5 mL molten agar at 46±1 degrees C.
DETERMINATION OF CYTOTOXICITY
Initial range-finder experiment was carried out in strains TA98, TA100 and TA102 (with and without S9), plus vehicle, untreated and positive controls.There was no clear evidence of toxicity up to a test-material concentration of 5 mg/plate.
The background lawns of all plates were examined for signs of toxicity. - 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.
Results which only partially satisfied the above criteria were dealt with on a case by case basis. Biological relevance was taken into account, for example consistency of response within and between concentrations and (where applicable) between experiments. Further experimental work may be deemed necessary to aid evaluation of the data. - Statistics:
- Individual plate counts were recorded separately and the mean and standard deviation of the plate counts for each treatment were determined.
The presence or otherwise of a concentration response was checked by non-statistical analysis, up to limiting levels
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
- Remarks:
- Expt 2 treatment in TA1537 produced a notable increase in revertants at the highest non-precipitating concentration. This was considered not to be a mutagenic effect (see below).
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Or a maximum test concentration of 5 mg/plate.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Experiment 2 treatments in strain TA1537 (without S9) at 1250 ug/plate (the highest non-precipitating concentration) resulted in an increase in revertant numbers (≥3-fold the concurrent control). The increase was small in magnitude and there was no clear indication of a concentration relationship or reproducibility between experiments; it was considered to have been due to normal biological variability and not evidence of mutagenic activity.
It should also be noted that following Experiment 2 treatments in strain TA100 in the absence of S 9, some of the untreated control revertant colony counts were higher than the historical control ranges and increases of 1.6-fold the concurrent vehicle controls were observed. In order to confirm if these increases were due to normal biological variability or mutagenicity, Experiment 2 additional treatments were performed in this strain. Following these treatments, no increases were observed that were ≥2-fold the concurrent vehicle controls. - Remarks on result:
- other: all strains/cell types tested
Applicant's summary and conclusion
- Conclusions:
- In a guideline Ames test, diammonium sodium hexakis(nitrito-N)rhodate failed to induce an increase in mutation frequency in five Salmonella typhimurium strains (TA98, TA100, TA1535, TA1537 and TA102), when tested at concentrations of up to 5000 μg/plate or up to the limit of cytotoxicity, in the absence and presence of S9.
- Executive summary:
Diammonium sodium hexakis(nitrito-N)rhodate was tested in a bacterial reverse mutation (Ames) assay, conducted according to OECD Test Guideline 471 and to GLP. The test substance was assayed 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 (S9), in two separate experiments. The highest concentrations of test article analysed were up to 5000 μg/plate or up to the limit of cytotoxicity and were determined following a preliminary toxicity range-finder experiment. In experiment 2, treatments in the presence of S9 included a pre-incubation step. Appropriate vehicle and positive control cultures were included in the test system under each treatment condition and fit the acceptance criteria.
Following treatments of all the test strains in the absence and presence of S9, only Experiment 2 treatments in strain TA1537 in the absence of S9 at 1250 μg/plate (the highest non-precipitating concentration) resulted in an increase in revertant numbers that was ≥3-fold the concurrent control. The increase was small in magnitude and occurred at a single intermediate concentration with no clear indication of a concentration relationship or reproducibility between experiments. Accordingly this was not considered evidence of mutagenic activity. Following Experiment 2 treatments in strain TA100 in the absence of S9, some of the untreated control revertant colony counts were higher than the historical control ranges and increases of 1.6-fold the concurrent vehicle controls were observed. In order to confirm if these increases were due to normal biological variability or mutagenicity, Experiment 2 additional treatments were performed in this strain; no increases were observed that were ≥2-fold the concurrent vehicle controls.
It is concluded that diammonium sodium hexakis(nitrito-N)rhodate did not induce mutation in five histidine-requiring strains (TA98, TA100, TA1535, TA1537 and TA102) of S. typhimurium when tested at concentrations up to 5000 μg/plate or up to the limit of toxicity, in the absence and in the presence of S9.
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