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Diss Factsheets
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EC number: 238-269-3 | CAS number: 14323-43-4
- 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
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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:
- 27 January 2012 (initiation) - 12 March 2012 (study completion)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline study, to GLP
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Very minor deviations documented; would not affect study integrity or results.
- Qualifier:
- according to guideline
- Guideline:
- other: UKEMS (Gatehouse et al. 1990, see below for full reference)
- Deviations:
- yes
- Remarks:
- Very minor deviations documented; would not affect study integrity or results.
- Qualifier:
- according to guideline
- Guideline:
- other: ICH 2A (1995) and ICH 2B (1997)
- Deviations:
- yes
- Remarks:
- Very minor deviations documented; would not affect study integrity or results.
- Principles of method if other than guideline:
- Guideline methods:
Gatehouse D G, Wilcox P, Forster R, Rowland I R and Callander R D (1990) Bacterial mutation assays. In "Basic Mutagenicity Tests UKEMS Recommended Procedures". Report of the UKEMS Sub-committee on Guidelines for Mutagenicity Testing. Part I Revised. Ed D J Kirkland. Cambridge University Press, pp 13-61.
ICH-S2A (1995). “Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals”.
ICH-S2B (1997). “Standard Battery for Genotoxicity Tests for Pharmaceuticals”. - GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Diamminedichloropalladium
- EC Number:
- 238-269-3
- EC Name:
- Diamminedichloropalladium
- Cas Number:
- 14323-43-4
- Molecular formula:
- Cl2H6N2Pd
- IUPAC Name:
- Diamminedichloropalladium
- Details on test material:
- - Name of test material (as cited in study report): diamminedichloropalladium
- Substance type: technical product
- Physical state: Solid (light orange powder)
- Analytical purity: >99.5% (Palladium content 50.33%)
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components (in ppm): Pt (<5); Ru (<2); Rh (6); Ir (<10); Au (<2); Ag (<2); Al (<2); Ca (<1); Co (<2); Cr (<1); Cu (3); Fe (<2); Mg (<2); Mn (<5); Ni (<1); Pb (<2); Sb (<10); Si (<10); Sn (<5); Zn (<2)
- Lot/batch No.: 11011
- Stability under test conditions: No data
- Storage condition of test material: 15-30 degrees C, protected from light
- Received: 12 January 2012
- Expiry date: 31 October 2012
Constituent 1
Method
- Target gene:
- Histidine operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- EXPERIMENT 1:
0, 0.126 (in the absence of S9 only), 0.4, 1.26, 4, 12.6, 40, 126 and 400 (in the presence of S9 only) ug/plate - in the presence and absence of S9 unless stated otherwise.
EXPERIMENT 2:
1.29, 3.226, 8.064, 20.16, 50.4 and 126 ug/plate - in the absence of S9
OR
4.096, 10.24, 25.6, 64, 160 and 400 ug/plate - in the presence of S9. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMF (dimethylformamide)
- Justification for choice of solvent/vehicle: Preliminary solubility data indicated that Diamminedichloropalladium was soluble in dimethylformamide (DMF) at concentrations of at approximately 4.00 mg/mL, the highest achievable concentration of the series tested. The other vehicles tested were purified water, acetone, ethanol, RPMI 1640 culture medium or tetrahydrofuran. Diamminedichloropalladium solubility in dimethyl sulphoxide (DMSO) was not performed at the request of the sponsor as certain chlorinated platinum analogues have been shown to react with DMSO in a manner which was considered likely to impact the scientific integrity of genotoxicity studies.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-NF; NaN3; AAC; MMC; B[a]P; AAN
- Details on test system and experimental conditions:
- For all assays, bacteria were cultured at 37±1 degrees C for 10 hours in nutrient broth, containing ampicillin (TA98, TA100) or ampicillin and tetracycline (TA102) as appropriate, to provide bacterial cultures in the range of approximately 108 to 109 cells/mL, based on cell count data from testing of each strain batch. Incubation was carried out with shaking in an anhydric incubator, set to turn on using a timer switch. All treatments were completed within 6 hours of the end of the incubation period.
The platings were achieved by the following sequence of additions to 2.5 mL molten agar at 46±1 degrees C:
• 0.1 mL bacterial culture
• 0.1 mL test article solution or control
• 0.5 mL 10% S-9 mix or buffer solution
followed by rapid mixing and pouring on to Vogel-Bonner E agar plates. When set, the plates were inverted and incubated at 37±1 degrees C in the dark for 3 days.
As the results of the first experiment were negative, treatments in the presence of S 9 in Experiment 2 included a pre-incubation step. Quantities of test article or control solution, bacteria and S 9 mix detailed above, plus an additional 0.5 mL of 500 mM sodium phosphate buffer (pH 7.4) were mixed together and incubated for 20 minutes at 37±1 degrees C, with shaking, before the addition of 2 mL of 1.125% molten agar at 46±1 degrees C. For the pre-incubation treatments, positive control volumes were reduced to 0.05 mL. Plating of these treatments then proceeded as for the normal plate incorporation procedure. In this way, it was hoped to increase the range of mutagenic chemicals that could be detected in the assay. (The addition of 0.5 mL of 500 mM sodium phosphate buffer (pH 7.4) to these Experiment 2 treatments was employed to reduce the solvent concentration during the pre-incubation period. DMF, and some other organic solvents, are known to be near to toxic levels when added at volumes of 0.1 mL in this assay system when employing the pre-incubation methodology. By employing the modification indicated, the DMF concentration in the pre-incubation mix was decreased, and it was hoped that this would minimise or eliminate any toxic effects of the solvent that may have otherwise occurred. In order to 'correct' for the additional volume in the pre incubation mix, these were plated out using 2 mL of 1.125% soft agar, therefore the additions to each plate were comparable to that of the plate-incorporation treatments. )
Following incubation, the plates were examined for evidence of toxicity to the background lawn, and where possible revertant colonies were counted either electronically using a Sorcerer Colony Counter (Perceptive Instruments), or manually where confounding factors such as a damaged plate or bubbles in the agar affected the accuracy of the automated counter.
Test concentrations and positive controls were tested in triplicate; negative controls were tested in quintuplicate.
The pH of the stock formulation prior to treatment was 12.03 in Experiment 1 and 12.71 in Experiment 2.
The test article was completely soluble in the aqueous assay system at all concentrations treated, in each of the experiments performed. - Evaluation criteria:
- For valid data, the test article was considered to be mutagenic if:
1. When assessed using Dunnett's test (which compared the counts at each concentration with the control), an increase in revertant numbers gave a statistically significant response (p less than or equal to 0.01) which was concentration related up to limiting levels (toxicity), as checked by non-statistical analysis.
2. The positive trend/effects described above were reproducible.
The test article was considered positive in this assay if all of the above criteria were met.
The test article was considered negative in this assay if none of the above criteria were met.
Results which only partially satisfied the above criteria were dealt with on a case by case basis. Biological relevance was taken into account, for example consistency of response within and between concentrations and (where applicable) between experiments. - Statistics:
- Analysed at the 1% level using Dunnett's test (for each test concentration compared to control).
Results and discussion
Test results
- 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
- Positive controls validity:
- valid
- Additional information on results:
- In experiment 1, complete toxicity was seen in all strains from 40 ug/plate in the absence of S9 and from 126 ug/plate in its presence. In experiment 2, complete toxicity was seen in all strains from 50.4 ug/plate in the absence of S9 and from 160 ug/plate in its presence
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Diamminedichloropalladium was not mutagenic in an Ames assay conducted according to OECD (and other relevant) guidelines and using five strains of Salmonella typhimurium, when tested up to limits of toxicity in the presence and absence of an S9 metabolic activation fraction (400 ug/plate in its presence and 126 ug/plate in its absence). - Executive summary:
Diamminedichloropalladium was tested for its ability to induce reverse mutations in an Ames assay conducted according to OECD Test Guideline 471, using five strains of the bacterium Salmonella typhimurium (TA98, TA100, TA102, TA1535 and TA1537), in the presence or absence of a rat liver metabolic activation (S9) system. Two experiments were conducted, up to the limit of toxicity (126 µg/plate in the absence of S9 and 400 µg/plate in its presence).
Diamminedichloropalladium was not mutagenic in this good-quality Ames assay using five strains of S. typhimurium, when tested up to a limit of toxicity, in the presence and absence of S9.
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