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EC number: 426-730-3 | CAS number: 123439-82-7
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 February 2007 to 26 June 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Guideline study, to GLP
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- historical control data not provided
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Council Directive 2000/32, Annex 4A (adapting 67/548/EWG Annex V/part B10)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 127733-97-5
- Cas Number:
- 127733-97-5
- IUPAC Name:
- 127733-97-5
- Details on test material:
- - Name of test material (as cited in study report): platinum(2+), tetraammine-,(SP-4-1)-, diacetate
- Substance type: no data
- Physical state: white crystalline powder
- Analytical purity: 46.95% Pt
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: 20 March 2006
- Lot/batch No.: AP013/06
- Expiration date of the lot/batch: 30 March 2007 (20 March 2007 on the label)
- Stability under test conditions: no data
- Storage condition of test material: room temperature, protected from light
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Ham's F.10 (499 ml), Penicillin G 50,000 IU/ml & streptomycin sulphate 50 mg/ml (1 ml), newborn calf serum (88.2 ml)
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: the report states that "the karyotype, generation time and plating efficiency have been checked in this laboratory
- Periodically "cleansed" against high spontaneous background: no data
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital and betanaphthoflavone-induced rat liver tissue fraction S9
- Test concentrations with justification for top dose:
- 39.1, 78.1, 156, 313, 625, 1250, 2500, 5000 µg/ml [equivalent to roughly 7.8, 15.6, 31.2, 62.6, 125, 250, 500 and 1000 µg/plate]
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water (sterile, distilled)
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- sterile distilled water (10%)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- Migrated to IUCLID6: at 0.3 and 0.45 µg/ml, without S9
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- sterile distilled water (10%)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- Migrated to IUCLID6: at 15 and 23 µg/ml, with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: no data
- Exposure duration: 3 hours (assay one); 20 hours (continuous treatment to sampling, assay two)
- Expression time (cells in growth medium): 20 hours (assay one)
- Fixation time (start of exposure up to fixation or harvest of cells): 23 hours (assay one); 20 hours (assay two)
SPINDLE INHIBITOR (cytogenetic assays): colcemid
STAIN (for cytogenetic assays): 3% Giemsa
NUMBER OF REPLICATIONS: Duplicate cultures
NUMBER OF CELLS EVALUATED: 100 per culture, 50 per culture in positive controls due to high incidence of aberrant cells (at least 50%)
DETERMINATION OF CYTOTOXICITY
- Method: relative cell growth
OTHER EXAMINATIONS:
- Determination of polyploidy: yes
- Determination of endoreplication: yes - Evaluation criteria:
- The test item was determined to be clastogenic if statistically significant increases were seen in the incidence of cells bearing aberrations at any dose-level over the concurrent control, exceeding historical control values, and reproduced in both replicate cultures.
- Statistics:
- Fisher's Exact Test was used to compare the number of cells bearing aberrations in control and treated cultures.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cell count slightly reduced (86% compared to control) at highest tested concentration (5000 µg/ml)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cell count slightly reduced (85% compared to control) at highest tested concentration (5000 µg/ml)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: pH monitored
- Effects of osmolality: osmolarity monitored
- Evaporation from medium: no data
- Water solubility: test compound was soluble in water at 5000 µg/ml
- Precipitation: no data
- Other confounding effects: no data
RANGE-FINDING/SCREENING STUDIES: no data
COMPARISON WITH HISTORICAL CONTROL DATA: not provided
ADDITIONAL INFORMATION ON CYTOTOXICITY: no data - Remarks on result:
- other: other: assay one (3-hour treatment)
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- In a guideline study, to GLP, tetraammineplatinum(II) diacetate did not induce chromosome aberrations in Chinese hamster ovary cells in vitro, both in the absence and presence of metabolic activation.
- Executive summary:
The clastogenicity of tetraammineplatinum(II) diacetate was assessed in an in vitro study on Chinese hamster ovary cells, conducted according to OECD Test Guideline 473 and to GLP.
Duplicate cultures were treated with the test substance at 39.1, 78.1, 156, 313, 625, 1250, 2500 or 5000 µg/ml [equivalent to up to 1000 µg/plate], both in the presence and absence of metabolic activation by rat liver fraction S9 (alongside appropriate vehicle, untreated, and positive controls). Following three hours of treatment, cells were harvested for twenty hours (at 37 °C). In a second assay, cells were treated with the test substance continuously until sampling at 20 hours, in the absence of metabolic activation.
Cells were checked for cytotoxicity following fixation and Giemsa staining. The cell count was slightly reduced to 85% of the control in cultures treated with 5000 µg/ml in the presence of S9. This level of cytotoxicity did not impede metaphase spread analysis, so cultures treated with the three highest tested concentrations (1250, 2500 and 5000 µg/ml) were scored for chromosome aberrations. In the second assay, the cell count was reduced to 86% of the control at the highest dose, but no cytotoxicity was observed over the remaining dose-range. In this case, cultures treated with 625, 1250 and 2500 µg/ml were selected for metaphase spread analysis.
No significant treatment-related increase was observed in the number of cells displaying chromosomes with gaps, deletions or exchanges, or in the number of polyploid or endoreplicated cells. It was therefore determined that tetraammineplatinum diacetate was not clastogenic in Chinese hamster ovary cells in vitro.
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