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EC number: 237-859-8 | CAS number: 14024-61-4
- 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 June - 22 October 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study, to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Minor study deviation did not affect overall interpretation of study findings or compromise integrity of the study
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Palladium di(4-oxopent-2-en-2-oate)
- IUPAC Name:
- Palladium di(4-oxopent-2-en-2-oate)
- Reference substance name:
- Palladium (II) di(4-oxopent-2-en-2-oate)
- EC Number:
- 237-859-8
- EC Name:
- Palladium (II) di(4-oxopent-2-en-2-oate)
- Cas Number:
- 14024-61-4
- Molecular formula:
- C10H14O4Pd
- IUPAC Name:
- Palladium (II) di(4-oxopent-2-en-2-oate)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Palladium (II) di(4-oxopent-2-en-2-oate)
- Physical state: Solid
- Analytical purity: 100%
- Impurities (identity and concentrations): Not applicable
- Composition of test material, percentage of components: Palladium 34.98%
- Isomers composition: Not applicable
- Purity test date: 29 May 2013
- Lot/batch No.: 21613
- Expiration date of the lot/batch: June 2014
- Stability under test conditions: Not identified
- Storage condition of test material: 15-25 deg C, protected from light, under nitrogen and in tightly closed container
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)
- Test concentrations with justification for top dose:
- Range-Finder (TA98; TA100; TA102 only):
0, 5, 15.81, 50, 158.1, 500, 1581, 5000 ug/plate (with and without S9)
Expt1
0, 0.1581 (without S9 only), 0.5, 1.581, 5, 15.81, 50, 158.1 ug/plate (with and without S9), 500 ug/plate (with S9 only)
Expt2
0, 1.563 (without S9 only), 3.125, 6.25, 12.5, 25, 50 ug/plate (with and without S9), 100 ug/plate (with S9 only) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: dimethyl formamide.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- mitomycin C
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation). In the presence of S9 in experiment 2, there is also a pre-incubation step.
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 3 days
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: Background lawns examined. - Evaluation criteria:
- An increase in revertant numbers that give a significant response which was concentration-related.
A positive trend/effect described are reproducible.
The test article was considered positive in this assay if all the above criteria are met. - Statistics:
- Dunnett's test was used to compare the counts at each concentration with the controls.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: The concentrations tested in the Ames test were determined in a preliminary cytotoxicity range-finder experiment.
COMPARISON WITH HISTORICAL CONTROL DATA: The number of revertants in negative (vehicle) and positive controls fell within the 99% confidence intervals of the current observed historial ranges. - Remarks on result:
- no mutagenic potential (based on QSAR/QSPR prediction)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
In a bacterial reverse mutation (Ames) test, conducted according to OECD Test Guideline 471 and to GLP, palladium di(4-oxopent-2-en-2-oate) failed to induce an increase in mutation frequency in five histidine-requiring strains (TA98, TA100, TA1535, TA1537 and TA102) of Salmonella typhimurium 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:
Palladium di(4-oxopent-2-en-2-oate) 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 by an Aroclor 1254-induced rat liver post-mitochondrial fraction (S9), in two separate experiments. The highest concentrations of test article analysed were limited by toxicity and were determined following a preliminary toxicity range-finder experiment.
In experiment 1, cells were treated with the test article at a maximum concentration of 158.1 µg/plate in the absence of S9, and 500 µg/plate in the presence of S9. Following these treatments, evidence of toxicity was observed in all strains at 15.81 µg/plate and above in the absence of S9 and at 50 µg/plate and above in the presence of S9.
In experiment 2, the maximum concentration was reduced to 50 µg/plate for all treatments in the absence of S9, and 100 µg/plate for treatments in the presence of S-9 based on toxicity observed in Experiment 1. All treatments in the presence of S9 were further modified by the inclusion of 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 palladium di(4-oxopent-2-en-2-oate) treatments of all the test strains in the absence and presence of S9, no statistically significant increases in revertant numbers were observed when the data were analysed at the 1% level using Dunnett’s test.
It is concluded that palladium di(4-oxopent-2-en-2-oate) 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 (the maximum recommended concentration according to current regulatory guidelines) or up to the limit of toxicity, in the absence and in the presence of S9.
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