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EC number: 604-667-4 | CAS number: 14898-67-0
- 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:
- 16 Sep - 9 Nov 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
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:
- Ruthenium trichloride hydrate
- EC Number:
- 604-667-4
- Cas Number:
- 14898-67-0
- Molecular formula:
- RuCl3.xH2O
- IUPAC Name:
- Ruthenium trichloride hydrate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Method
- Target gene:
- histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- mammalian liver post-mitochondrial fraction (S9) prepared from male Sprague Dawley rats induced with Aroclor 1254
- Test concentrations with justification for top dose:
- Range-finder experiment and mutation experiment 1: 5, 16, 50, 160, 500, 1600 and 5000 µg/plate.
Mutation experiment 2: 160, 300, 625, 1250, 2500 and 5000 µg/plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: purified water
- Justification for choice of solvent/vehicle: well-known solvent/vehicle
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA98 -S9 5 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA100 TA1535 -S9 2 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537 -S9 50 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- TA102 -S9 0.2 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- TA98 +S9 10 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- TA100 TA1535 TA1537 +S9 5 µg/plate; TA102 +S9 20 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Toxicity Range-Finder Experiment, Mutation Experiment 1: in agar (plate incorporation); Mutaion Experiment 2: preincubation
DURATION
- Preincubation period: Mutation Experiment 2: 20 minutes
- Exposure duration: 3 days
DETERMINATION OF CYTOTOXICITY
- Method: plates were examined for evidence of toxicity to the background lawn - Evaluation criteria:
- 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 [n]either of the above criteria were met. - Statistics:
- None
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- In Mutation Experiment 1: from 500 to 5000 µg/plate -S9 and from 1600-5000 µg/plate +S9; Mutation Experiment 2: 2000 and/or 5000 µg/plate -S9 and +S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- In Mutation Experiment 1: from 500 to 5000 µg/plate -S9 and from 1600-5000 µg/plate +S9; Mutation Experiment 2: 2000 µg/plate -S9 and +S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: pH of 50 mg/mL stock formulations was 0.79-0.93.
- Effects of osmolality: no data
- Water solubility: Preliminary solubility data indicated that Ruthenium (III) chloride hydrate was soluble in water for irrigation (purified water) at concentrations equivalent to at least 50 mg/mL.
- Precipitation: Toxicity Range-Finder Experiment and Mutation Experiment 1: no precipitation; Mutation Experiment 2: precipitation at 625 µg/plate and above in all strains in the presence of S9 only
RANGE-FINDING/SCREENING STUDIES: An initial toxicity Range-Finder Experiment was carried out in the absence and in presence of S9 in strains TA98, TA100 and TA102, using final concentrations of Ruthenium (III) chloride hydrate at 5, 16, 50, 160, 500, 1600, and 5000 μg/plate, plus vehicle and positive controls. Following these treatments evidence of toxicity was observed at 1600 and/or 5000 μg/plate in all strains in the absence and presence of S9.
COMPARISON WITH HISTORICAL CONTROL DATA: Mean vehicle control counts fell within the laboratory’s historical ranges; mean positive control counts fell within or slightly above the laboratory's historical control ranges, except for Mutation Experiment 2, TA1535 +S9 for which the mean positive control count was 115.7 and the historical control range was 127-398 (the effect was, nevertheless, clearly positive). - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- In a guideline study, to GLP, ruthenium (III) chloride hydrate did not induce mutations in five histidine-requiring strains of Salmonella typhimurium, when tested up to 5 mg/plate in the absence or presence of a rat liver metabolic activation system (S9).
- Executive summary:
Ruthenium trichloride hydrate 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 S. typhimurium, both in the absence and in the presence of metabolic activation (S9), in two separate experiments (each in triplicate). 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 1 a plate incorporation protocol was used; the experiment was repeated using a pre-incubation step. Appropriate vehicle and positive control cultures were included in the test system under each treatment condition.
There was no evidence of mutagenicity in any strain with or without S9 in either experiment. Some evidence of toxicity was observed at 1600 and/or 5000 µg/plate with the plate incorporation protocol and at 1250 and/or 2500 µg/plate with the pre-incubation protocol. Vehicle and positive controls performed as expected. It is concluded that ruthenium trichloride hydrate 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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