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EC number: 286-924-7 | CAS number: 85392-65-0
- 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:
- 28 July - 21 September 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:
- Tetraammonium-decachloro-mu-oxodiruthenate
- IUPAC Name:
- Tetraammonium-decachloro-mu-oxodiruthenate
- Reference substance name:
- Tetraammonium decachloro-μ-oxodiruthenate(4-)
- EC Number:
- 286-924-7
- EC Name:
- Tetraammonium decachloro-μ-oxodiruthenate(4-)
- Cas Number:
- 85392-65-0
- Molecular formula:
- Cl10ORu2.4H4N
- IUPAC Name:
- tetraammonium decachloro-μ-oxodiruthenate(4-)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): tetraammonium-decachloro-mu-oxodiruthenate
- Substance type: brown powder
- Physical state: solid
- Analytical purity: 98%
- Impurities (identity and concentrations): metallic impurities 0.3%
- Composition of test material, percentage of components: ((NH4)4Ru2Cl10O x H2O 98.0%, NH4Cl 0.7%, H2O 1.0%)
- Isomers composition: no data
- Purity test date: 15-Jul-2015
- Lot/batch No.: 71495159
- Expiration date of the lot/batch: 11-Jun-2016
- Stability under test conditions: no data
- Storage condition of test material: store in a cool, dry place in tightly closed containers at 5-25 deg C, shelf life 12 months from date of delivery
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
- 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: 5, 16, 50, 160, 500, 1600 and 5000 µg/plate
Experiment 1: 5, 16, 50, 160, 500, 1600 and 5000 µg/plate
Experiment 2: 20.48, 51.2, 128, 320, 800, 2000 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:
- Strain 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
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- TA102 +S9 20 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Range-finder experiment (with and without S9), Experiment 1 (with and without S9) and Experiment 2 (without S9): in agar (plate incorporation); Experiment 2 (with S9): preincubation
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 3 days
DETERMINATION OF CYTOTOXICITY
- Method: The background lawns of the plates were examined for signs of toxicity. Other evidence of toxicity may have included a marked reduction in revertants compared to the concurrent vehicle controls and/or a reduction in mutagenic response. - Evaluation criteria:
- Acceptance Criteria: 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 S9 preparation.
Evaluation Criteria: For valid data, the test article was considered to be mutagenic if:
3. 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
4. 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:
- 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 Experiment 1 (plate incorporation protocol): at 500 µg/plate, without S9; at 1600 µg/plate, with S9) (in Experiment 2: at 2000 µg/plate, without S9 (plate incorporation); at 5000 µg/plate, with S9 (pre-incubation))
- 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 Experiment 1 (plate incorporation protocol): at 500 µg/plate, without S9; at 1600 µg/plate, with S9) (in Experiment 2: at 2000 µg/plate, without S9 (plate incorporation); at 5000 µg/plate, with S9 (pre-incubation))
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: Range-finder experiment: stock solution (filter sterilised), 20 mg Tetraammonium-decachloro-mu-oxodiruthenate/ml, pH 3; Experiment 1: pH of stock solution not measured (in error); Experiment 2: stock solution (not filter sterilised), 20 mg Tetraammonium-decachloro-mu-oxodiruthenate/ml, pH 2.19
- Precipitation: at 5000 µg/plate, Experiment 2 only
RANGE-FINDING/SCREENING STUDIES: strains TA98, TA100 and TA102; evidence of toxicity in the form of a slight thinning of the background bacterial lawn was observed at 5000 µg/plate in all strains in the absence and presence of S9
COMPARISON WITH HISTORICAL CONTROL DATA: mean vehicle control counts were comparable with the laboratory’s historical ranges; mean positive control counts were generally within or higher than the laboratory's historical control ranges - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- In a guideline bacterial reverse mutation (Ames) test, to GLP, tetraammonium-decachloro-mu-oxodiruthenate 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:
Tetraammonium-decachloro-mu-oxodiruthenate 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 by an Aroclor 1254-induced rat liver post-mitochondrial fraction (S9), in two separate experiments (each in triplicate): in experiment 1, a plate incorporation protocol was used; the experiment was repeated, using an additional pre-incubation step for the test with S9. 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. Appropriate vehicle and positive control cultures were included in the test system under each treatment condition and fit the acceptance criteria.
There was no evidence of mutagenicity in any strain with or without S9 in either experiment. There was some evidence of toxicity at 500-5000 µg/plate with the plate incorporation protocol and at 2000-5000 µg/plate with the pre-incubation protocol. Vehicle and positive controls performed as expected.
It is concluded that tetraammonium-decachloro-mu-oxodiruthenate did not induce mutations in five strains 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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