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EC number: 236-957-8 | CAS number: 13566-03-5
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- 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:
- 21 February 2008 to 13 March 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD, Japan)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine for S. typhimurium strains; tryptophan for E.coli WP2 uvrA
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9, microsomal fraction derived from phenobarbital- and 5,6-benzoflavone-induced rat liver
- Test concentrations with justification for top dose:
- 2.4, 4.9, 10, 20, 39 or 78 μg/plate in tests without S9
10, 20, 39, 78, 156 or 313 μg/plate in tests with S9
(These concentrations were selected after a preliminary test using doses of 1.2, 4.9, 20, 78, 313, 1250 or 5000 μg/plate showed that growth inhibition occurred at and above 78 and 313 μg/plate, respectively without and with S9) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: dehydrated DMSO
- Justification for choice of solvent/vehicle: at request of sponsor and after solubility tests - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- 5.0 μg/plate for TA1537, TA98 and TA100 with S9
- Positive control substance:
- sodium azide
- Remarks:
- 0.5 μg/plate for TA1535 without S9
- Positive control substance:
- other: 2-aminofluorene
- Remarks:
- 0.01 μg/plate for TA100 and E. coli WP2 uvrA and 0.1 μg/plate for TA98 without S9
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- 2.0 μg/plate for TA1535 and 10 μg/plate for E. coliWP2 uvrA with S9
- Positive control substance:
- other: ICR-191
- Remarks:
- 1.0 μg/plate for TA1537 without S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 hr
NUMBER OF REPLICATIONS: plates prepared in triplicate; duplicate studies carried out.
OTHER: The preparations of the test solutions and the study procedures were conducted under lamps with ultraviolet light absorbent filters. - Evaluation criteria:
- The test substance was considered to demonstrate mutagenic activity if the number of revertant colonies was at least double that of the spontaneous mutants on the control plates and showed a reproducible dose-response.
- 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:
- at 78 μg/plate without S9 for all strains and at 156 and 313 μg/plate with S9
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 78 μg/plate without S9 for all strains and at 156 and 313 μg/plate with S9
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: a preliminary test showed cytotoxicity at and above 78 and 313 μg/plate, respectively without and with S9. No increase in mutation frequency was observed with the test substance
COMPARISON WITH HISTORICAL CONTROL DATA: no data given in the report but the frequency of spontaneous revertants are within the ranges given in the literature. Mutation frequency for the positive control substances were reported to be within the historic range
ADDITIONAL INFORMATION ON CYTOTOXICITY: - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
Palladium (II) sulphate hydrate did not cause an increase in mutation frequency when tested at up to the limits of cytotoxicity, either with or without S9, in a guideline (GLP) bacterial reverse mutagenicity assay. - Executive summary:
In a OECD Test Guideline 471 study, to GLP, the mutagenic potential of palladium (II) sulphate hydrate was assessed in a reverse mutagenicity assay (Ames test) using the S. typhimurium strains TA1535, TA1537, TA98 and TA100 and E. coli WP2 uvrA.
Two independent experiments (each in triplicate) were carried out using the preincubation method, both with and without S9. A preliminary range-finding study had shown the test substance to be cytotoxic at doses at and above 78 and 313 μg/plate, respectively, without and with S9. In consequence these were the top doses tested.
Palladium (II) sulphate hydrate did not cause an increase in mutation in these studies, either with or without S9. In contrast, the known mutagens used as positive controls showed the expected mutagenic activity.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
No data identified.
Endpoint conclusion
- Endpoint conclusion:
- no study available
Mode of Action Analysis / Human Relevance Framework
No data identified.
Additional information
No studies conducted in humans were identified.
In an OECD Test Guideline 471 study, to GLP, the mutagenic potential of palladium (II) sulphate hydrate was assessed in a reverse mutagenicity assay (Ames test) using the Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2 uvrA. At the limit of cytotoxicity (78 and 313 μg/plate, respectively, without and with S9), palladium (II) sulphate hydrate did not cause an increase in mutation frequency. In contrast, the known mutagens used as positive controls showed the expected mutagenic activity (Sarada, 2008).
Justification for selection of genetic toxicity endpoint
OECD guideline study, to GLP, and the only in vitro genetic toxicity study available.
Justification for classification or non-classification
No evidence of genotoxic activity was seen in a reliable mutagenicity assay in bacterial cells. No studies specifically assessing the mutagenic activity in germ cells were identified. However, the available evidence provides no basis for classifying palladium sulphate for germ cell mutagenicity, according to EU CLP criteria (EC 1272/2008).
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