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EC number: 262-819-1 | CAS number: 61495-96-3
- 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:
- 9 February-10 April 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, to GLP, on closely-related surrogate. Astrain capable of detecting certain oxidising mutagens and/or cross-linking agents, for example TA102, was not included.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Astrain capable of detecting certain oxidising mutagens and/or cross-linking agents, for example TA102, was not included.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- yes
- Remarks:
- Astrain capable of detecting certain oxidising mutagens and/or cross-linking agents, for example TA102, was not included.
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Tetramminepalladium hydrogen carbonate
- IUPAC Name:
- Tetramminepalladium hydrogen carbonate
- Reference substance name:
- 134620-00-1
- Cas Number:
- 134620-00-1
- IUPAC Name:
- 134620-00-1
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Tetrammine palladium hydrogen carbonate
- Substance type: No data
- Physical state: pale yellow powder
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: DD0247
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: room temperature
Constituent 1
Constituent 2
Method
- Target gene:
- Histidine
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1538
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver homogenate metabolising system (S9)
- Test concentrations with justification for top dose:
- 0, 50, 150, 500, 1500 and 5000 µg/plate in preliminary cytotoxicity test
0, 0.15 (Expt 1 only), 0.5, 1.5, 5, 15, 50 (-S9)
0, 1.5, 5, 15, 50, 150, 500 (Expt 1 only) (+S9) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Sterile distilled water
- Justification for choice of solvent/vehicle: Test guideline recommends use of aqueous solvent wherever possible
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- 80 µg/plate for TA 1537 without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- 0.2 µg/plate for TA 98 without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenyl enediamine
- Remarks:
- 5 µg/plate for TA 1538 without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- 3 and 5 µg/plate for TA 100 and 1535 respectively (both without S9)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- 1, 2, 0.5, 0.5 and 2 µg/plate for TA 100, 1535, 1538, 98 and 1537 strains respectively (all with S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: Not applicable
- Exposure duration: 48 hours
- Expression time (cells in growth medium): Not applicable
- Selection time (if incubation with a selection agent): Not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): Not applicable
SELECTION AGENT (mutation assays): Not applicable
SPINDLE INHIBITOR (cytogenetic assays): Not applicable
STAIN (for cytogenetic assays): Not applicable
NUMBER OF REPLICATIONS: 3 (Experiment carried out twice)
NUMBER OF CELLS EVALUATED: Not applicable
DETERMINATION OF CYTOTOXICITY
- Method: Reduction in no. of revertant colonies/thining of background lawn
OTHER EXAMINATIONS:
- Determination of polyploidy: Not applicable
- Determination of endoreplication: Not applicable - Evaluation criteria:
- Positive results should have a dose-related and statistically significant increase in mutation rate in one or more bacterial strains with or without S9. To be considered negative, the number of induced revertants should be less than twofold compared to spontaneous revertants (controls).
- Statistics:
- No data
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- The test material caused a visible reduction in the growth of the bacterial lawn at 50 and 150 µg/plate and above for tester strains without and with metabolic activation respectively
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- The test material caused a visible reduction in the growth of the bacterial lawn at 50 and 150 µg/plate and above for tester strains without and with metabolic activation respectively
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- The test material caused a visible reduction in the growth of the bacterial lawn at 50 and 150 µg/plate and above for tester strains without and with metabolic activation respectively
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- The test material caused a visible reduction in the growth of the bacterial lawn at 50 and 150 µg/plate and above for tester strains without and with metabolic activation respectively
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- The test material caused a visible reduction in the growth of the bacterial lawn at 50 and 150 µg/plate and above for tester strains without and with metabolic activation respectively
- 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: No data
- Effects of osmolality: No data
- Evaporation from medium: No data
- Water solubility: No data
- Precipitation: No data
- Other confounding effects: No data
RANGE-FINDING/SCREENING STUDIES: The dose range used was 0, 50, 150, 500, 1500 and 5000 µg/plate
COMPARISON WITH HISTORICAL CONTROL DATA: No data
ADDITIONAL INFORMATION ON CYTOTOXICITY: The test material caused a visible reduction in the growth of the bacterial lawn at 50 and 150 µg/plate and above for tester strains without and with metabolic activation respectively - Remarks on result:
- other: strain/cell type: TA 100
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
In a guideline study, to GLP, tetraamminepalladium hydrogen carbonate was not mutagenic in a bacterial reverse mutation (Ames) assay using five Salmonella typhimurium strains (TA98, TA100, TA1535, TA1537 and TA1538), when tested at up to cytotoxic concentrations in the presence and absence of a rat liver metabolic activation (S9) system - Executive summary:
Tetraamminepalladium hydrogen carbonate was assessed for potential mutagenic activity in a bacterial reverse mutation (Ames) assay, conducted according to OECD Test Guideline 471, and to GLP. The test compound was tested in five strains of Salmonella typhimurium (TA98, TA100, TA1535, TA1537 and TA1538). (However, a strain capable of detecting certain oxidising mutagens and/or cross-linking agents, for example TA102, was not included.)
The dose ranges were determined in a preliminary assay for cytotoxicity and were 0.15-50 and 1.5-500 µg/plate with and without the addition of a rat liver homogenate metabolising (S9) system. All assays were carried out in triplicate, at up to 50 and 500 µg/plate in the absence and presence of S9, respectively. The experiment was repeated.
Tetraamminepalladium hydrogen carbonate showed no evidence of a dose-related increase in revertant frequency at any dose levels in any each strain, either in the presence or absence of S9.
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