Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 260-633-5 | CAS number: 57219-64-4
- 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 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:
- From 19 February 2013 to 21 March 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented GLP study performed according to OECD Guideline 473 and EU Method B.10.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- [μ-[carbonato(2-)-O:O']]dihydroxydioxodizirconium
- EC Number:
- 260-633-5
- EC Name:
- [μ-[carbonato(2-)-O:O']]dihydroxydioxodizirconium
- Cas Number:
- 57219-64-4
- Molecular formula:
- CH2O7Zr2
- IUPAC Name:
- [({[Hydroxy(Oxo)Zirconio]Oxy}Carbonyl)Oxy]Zirconiumoylol
- Details on test material:
- - Name of test material (as cited in study report): zirconium basic carbonate
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: Cultures were grown in Ham's F10 medium supplemented with 15% foetal bovine serum. All incubations were at 37°C in a 5% carbon dioxide atmosphere (100% humidity nominal).
- Properly maintained: yes
- Periodically "cleansed" against high spontaneous background: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital and 5,6-Benzoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Main experiment 1: 5.35, 2.68, 1.34, 0.669, 0.334, 0.167, 0.0836, 0.0418, 0.0209 and 0.0104 mM (corresponding to 3080, 1540, 770, 385, 193, 96.3, 48.1, 24.1, 12.0 and 6.02 µg/mL of zirconium basic carbonate hydrate; corresponding to 1650, 825, 413, 206, 103, 51.6, 25.8, 12.9, 6.44 and 3.22 µg/mL of zirconium basic carbonate anhydrous)
Main experiment 2: 5.35, 3.06, 1.75, 0.998, 0.570, 0.326, 0.186, 0.106, 0.0608 and 0.0348 mM (corresponding to 3080, 1760, 1010, 575, 328, 188, 107, 61.3, 35.0 and 20.0 µg/mL zirconium basic carbonate hydrate; corresponding to 1650, 943, 539, 308, 176, 101, 57.4, 32.8, 18.8 and 10.7 µg/mL zirconium basic carbonate anhydrous) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without S9 at 0.450 and 0.300 µg/mL in experiment 1 and without S9 at 0.150 and 0.100 µg/mL in experiment 2
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- 23.0 and 15.0 µg/mL with S9 in experiment 1
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 3 hours in experiment 1 with and without S9; 20 hours in experiment 2
- Expression time (cells in growth medium): No data
- Harvest of cells at 20 hours (approximately 1.5 cell cycle length)
- Fixation time (start of exposure up to fixation or harvest of cells): No data, two cultures were prepared at each test point. Air-dried slides were prepared from each culture and stained with 3% Giemsa.
STAIN (for cytogenetic assays): Giemsa 3%
NUMBER OF REPLICATIONS: duplicate
NUMBER OF CELLS EVALUATED: One hundred metaphase spreads were scored for chromosomal aberrations from each culture with the exception of replicate cultures treated with the positive control cyclophosphamide from the first experiment in the presence of S9 metabolism, where, due to the high incidence of aberrant cells (excluding gaps), scoring was terminated at 50 metaphases.
DETERMINATION OF CYTOTOXICITY
- Method: reduction of population doubling
OTHER EXAMINATIONS:
- Determination of polyploidy: yes
- Determination of endoreplication: yes - Evaluation criteria:
- In this assay, the test item was considered to have clastogenic properties if the following criteria were all fulfilled:
- Statisticallly significant increases in the incidence of cells bearing aberrations were observed at any dose level over the current control.
- The increases exceeded the historical control values.
- The increases were reproduced in both replicate cultures.
The evaluation was based on the set of results, which excluded gaps. - Statistics:
- For the statistical analysis, Fisher's Exact Test was used to compare the number of cells bearing aberrations (assumed to be Poisson distributed) in control and treated cultures. The analysis was performed using sets of data either including or excluding gaps.
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Details are specified in the field 'Additional information on results'
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: Following treatment with the test item, no remarkable variation of pH over the vehicle control values were observed at any dose level, in the absence or presence of S9 metabolism.
- Effects of osmolality: Following treatment with the test item, no remarkable variation of osmolality over the vehicle control values was observed at any dose level, in the absence and presence of S9 metabolism. It should be noted that an increase in osmolality was determined by the presence of DMSO in the treatment medium since the solvent depresses the freezing point. However, it passed freely in and out of cells, hence the increases were only apparent. A slight dose related reduction of the osmolality values over the vehicle control was observed at higher dose levels. These reductions were attributable to the DMSO displacement in the test item suspensions.
- Water solubility: Solubility of the test item was evaluated in a preliminary trial using sterile distilled water, culture medium, dimethylsulfoxide (DMSO), ethanol and acetone. These solvents were selected since they were compatible with the survival of the cells and the S9 metabolic activity. In addition, there were many historical control data demonstrating that no mutagenic effects were induced by the chosen solvents. The test item was not found to be soluble in any solvent. Solubility at low pH conditions was evaluated without better results. On the basis of these results and in agreement with the Study Monitor, it was decided to use the test item as homogeneous suspensions in DMSO obtaining the maximum final concentration of 5.35 mM.
- Precipitation: During the first main experiment, dose related precipitation was observed at the three highest dose levels at the beginning and by the end of treatment. During the second main experiment, upon addition of the test item to the cultures, slight dose related precipitation and opacity were observed at concentration levels between 5.35 and 0.570 mM. By the end of treatment, opacity of the treatment medium was observed at the three highest dose levels, while few particles of test item adherent to the flask surfaces were noted at all concentrations tested.
COMPARISON WITH HISTORICAL CONTROL DATA:
The frequency of cells bearing chromosomal aberrations in untreated and vehicle control cultures was within the laboratory historical control data.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In the first main experiment, following treatment in the absence of S9 metabolism, mild toxicity was observed at the highest dose level (5.35 mM) where the relative population doubling was 63% of the concurrent vehicle control value. No relevant toxicity was observed over the remaining dose range.
In the presence of S9 metabolism, the highest dose level tested yielded slight toxicity reducting the relative population doubling value to 72% of the concurrent negative control. No toxicity was observed over the remaining dose range.
In the second main experiment, the maximum dose level of 5.35 mM yielded a marked cytotoxicity reducing the population doubling value to 17% of the control, while no relevant toxicity was noted at lower dose levels. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Following treatment with zirconium basic carbonate, no relevant increases over the concurrent vehicle control in the incidence of cells bearing aberrations were observed in any experiment.
A few polyploid or endoreduplicated cells were randomly observed in treated and control cultures. The incidences however were within the range of the laboratory historical control values for negative control.
Marked and biologically relevant increases in the frequency of cells bearing aberrations (including and excluding gaps) were seen in the cultures treated with the positive control substances, indicating the correct functioning of the assay system.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
On the basis of the results, it is concluded that zirconium basic carbonate does not induce structural chromosomal aberrations in Chinese hamster ovary cells after in vitro treatment with and without metabolic activation (S9), under the reported experimental conditions.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.