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EC number: 231-841-3 | CAS number: 7758-88-5
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 3 November 2005 to 17 May 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- Cited as Directive 2000/32/EC, B.17
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Dicerium tricarbonate
- EC Number:
- 208-655-6
- EC Name:
- Dicerium tricarbonate
- Cas Number:
- 537-01-9
- IUPAC Name:
- dicerium tricarbonate
- Details on test material:
- - Physical state: solid
- Storage condition of test material: at room temperature
Constituent 1
Method
- Target gene:
- HPRT
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: minimal essential medium (MEM) supplemented with 10% fetal calf serum
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 fraction of rats induced with Phenobarbital/beta-Naphthoflavone
- Test concentrations with justification for top dose:
- - Experiment I: 143.8; 287.5; 575; 1150; and 2300 µg/mL with and without S9-mix
- Experiment II: 143.8; 287.5; 575; 1150; and 2300 µg/mL without S9-mix, 287.5; 575; 1150; 1725; and 2300 µg/mL with S9-mix
See also table 1 below. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: deionised water
- Justification for choice of solvent/vehicle: data not available
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- culture medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- medium with solvent or vehicle alone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- Migrated to IUCLID6: (EMS): 0.3 mg/mL without metabolic activation
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Remarks:
- Migrated to IUCLID6: (DMBA): 2.0 µg/mL with metabolic activation
- Details on test system and experimental conditions:
- - METHOD OF APPLICATION: in suspension
- DURATION
- Exposure duration: 4h in experiment I with or without metabolic activation, 24h in the absence and 4h in the presence of metabolic activation in experiment II
- Expression time: 7 days
- Selection time: 8 days in 6-TG
- Fixation time: Day 15 or day 16
- SELECTION AGENT: thioguanine (6-TG)
- STAIN: in 10 % methylene blue in 0.01 % KOH solution
- NUMBER OF REPLICATES: two
- DETERMINATION OF CYTOTOXICITY: cloning efficiency
- OTHER: SCORING METHOD: The stained colonies with more than 50 cells are counted. In doubt the colony size was checked with a preparation microscope - Evaluation criteria:
- A test material producing neither a concentration- related increase of the mutant frequency nor a reproducible positive response at any of the test points is considered non-mutagenic in this system.
A positive response is described as follows:
A test material is classified as mutagenic if it reproducibly induces a mutation frequency that is three times above the spontaneous mutation frequency at least at one of the concentrations in the experiment.
The test material is classified as mutagenic if there is a reproducible concentration-related increase of the mutation frequency. Such evaluation may be considered also in the case that a threefold increase of the mutant frequency is not observed. - Statistics:
- Since the distribution of mutant cells does not follow known statistical models, an adequate statistical method is not available.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no effect observed
- Effects of osmolality: no effect observed
- Precipitation: Precipitation was observed at 1150 µg/mL and above in the first main experiment with and without metabolic activation (4 h treatment). In the second experiment without metabolic activation (24 h treatment), precipitation occurred at 575 µg/mL and above. In the second experiment with metabolic activation, precipitation was noted at 1150 µg/mL and above (4 h treatment).
RANGE-FINDING/SCREENING STUDIES:
A pre-test was performed in order to determine the concentration range for the mutagenicity experiments.
No relevant toxic effect (relative cloning efficiency at or below 50 %) occurred up to the highest concentration following 4 h treatment in the presence of metabolic activation. In the absence of metabolic activation relevant toxicity was noted at the maximum concentration of 4600 µg/mL.
Following 24 h treatment, performed solely without metabolic activation, no relevant toxic effect was observed up to 143.8 µg/mL. At the concentration of 575 µg/mL the cloning efficiency was reduced to 40.2 % of solvent control. No toxicity data were generated at 287.5 µg/mL and at 1150 µg/mL and above due to microbial contamination of the cells.
The test medium was checked for precipitation with the unaided eye at the end of each treatment period (4 or 24 hours) just prior to removal of the test material. Precipitation was observed at 575.0 µg/mL and above in the absence and presence of metabolic activation at both treatment intervals.
COMPARISON WITH HISTORICAL CONTROL DATA:
The mutant frequencies generally remained within the historical range of negative and solvent controls.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Relevant toxic effects solely occurred at the maximal concentration of 2300 µg/mL in the second experiment without metabolic activation.
See detailed results in table 2 (attached document) - 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 with and without metabolic activation
In conclusion it can be stated that under the experimental conditions reported the test material did not induce gene mutations at the HPRT locus in V79 cells. - Executive summary:
In a mammalian cell gene mutation assay (HPRT locus) (Wollny, 2006), Chinese hamster V79 cells cultured in vitro were exposed to Cerium carbonate, in deionised water, at concentrations of 143.8 to 2300 µg/mL in the presence and absence of mammalian metabolic activation. Cerium carbonate was tested up to precipitating concentrations.
The positive controls induced the appropriate response. There was no evidence of induced mutant colonies over background.
Therefore, Cerium carbonate is considered to be non-mutagenic in this HPRT assay.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline EU Method B.17.
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