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EC number: 682-131-9 | CAS number: 1190427-50-9
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-2-3 to 2016-6-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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)
- Version / remarks:
- 21st July, 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- [1,3-bis(2,4,6-trimethylphenyl)-4,5-dimethylimidazol-2-ylidene](2-thienylmethylidene)(tricyclohexylphosphine)ruthenium(II)dichloride
- Cas Number:
- 1190427-50-9
- Molecular formula:
- C46H65Cl2N2PRuS
- IUPAC Name:
- [1,3-bis(2,4,6-trimethylphenyl)-4,5-dimethylimidazol-2-ylidene](2-thienylmethylidene)(tricyclohexylphosphine)ruthenium(II)dichloride
- Test material form:
- solid: particulate/powder
Constituent 1
Method
- Target gene:
- S. typhimurium histidine (his) reversion system and the E. coli tryptophan (trp) reversion system.
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 3.16, 10.0, 31.6, 100, 316, 1000, 2500 and 5000 μg/plate
According to guideline, top dose is the recommended maximum test concentrationfor soluble non-toxic test compounds. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: test compound is insoluble in water, DMSO was compatible with the survival of the bacteria used and with S9 activity.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Pre-experiment and Experiment I: in agar (plate incorporation); Experiment II: preincubation
DURATION
- Preincubation period: 60 min
- Exposure duration: at least 48 h
SELECTION AGENT (mutation assays): L-histidine for S. typhimurium; tryptophan for E. coli
NUMBER OF REPLICATIONS: 3 plates per test condition
DETERMINATION OF CYTOTOXICITY
- Method: clearing/diminution of background lawn or a reduction in the number of revertants down to a mutation factor of approximately ≤ 0.5 in relation to the solvent control - Rationale for test conditions:
- test conditions were according to the standard OECD Guideline
- Evaluation criteria:
- A test was considered acceptable if for each strain:
- the bacteria demonstrated their typical responses to ampicillin (TA 98, TA 100)
- mean values of spontaneous reversion frequency of the negative control plates (A. dest.), with and without S9 mix, fell within the historical control data range (2012 -2014)
- corresponding background growth on both negative control and test plates was observed.
- the positive controls showed a distinct enhancement of revertant rates over the control plate
- at least five different concentrations of each tester strain could be analyzed
Evaluation of Mutagenicity:
The Mutation Factor was calculated by dividing the mean value of the revertant counts by the mean values of the solvent control
A test item was considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occured and/or
- a biologically relevant positive response for at least one of the dose groups occured
in at least one tester strain with or without metabolic activation.
A biologically relevant increase as described as follows:
- if in tester strains TA 98, TA 100 and E. coli WP2 uvrA the number of reversions was at least twice as high
- if in tester strains TA 1535 and TA 1537 the number of reversions was at least three times higher
when compared to the reversion rate of the solvent control.
According to the OECD guideline, the biological relevance of the results was the criterion for the interpretation of results, a statistical evaluation of the results was not regarded as necessary.
A test item producing neither a dose related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups iexamined, was considered to be non-mutagenic.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The test item did not exert cytotoxicity and, without metabolic activation, precipitation of the test item was observed in all tester strains used in experiment I and II at concentrations of 316 μg/plate and higher. With metabolic activation, precipitation was observed at concentrations of 1000 μg/plate and higher.
Any other information on results incl. tables
Please see attached file for results.
Applicant's summary and conclusion
- Conclusions:
- No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with the test item at any concentration level, neither in the presence nor absence of metabolic activation in both a plate incorportion and a pre-incubation experiment. The reference mutagens induced a distinct increase of revertant colonies demonstrating the validity of the experiments and the functionality of the S9-mix used. Under the experimental conditions used, the test substance did neither cause gene mutations by base pair changes nor by frameshift in the genome of the tester strains used and is, therefore, considered to be non-mutagenic in the bacterial reverse mutation assay.
- Executive summary:
A valid bacterial reverse mutation assay according to OECD Guideline 471 and under GLP did not identify any signs of mutagenicity .
for genotoxicity according to OECD TG 471 and under GLP
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