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EC number: 281-192-5 | CAS number: 83897-84-1
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- no data available
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented publication.
Data source
Reference
- Reference Type:
- publication
- Title:
- Ability of root canal antiseptics used in dental pratice to induce chromosome aberrations in human dental pulp cells
- Author:
- Nishimura, H.; et al.
- Year:
- 2 008
- Bibliographic source:
- Mut. Res. 649, 45-53
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Examination of the ability to induce chromosome aberrations in human dental pulp cells.
- GLP compliance:
- no
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Calcium dihydroxide
- EC Number:
- 215-137-3
- EC Name:
- Calcium dihydroxide
- Cas Number:
- 1305-62-0
- IUPAC Name:
- calcium dihydroxide
- Details on test material:
- - Name of test material (as cited in study report): Calcium hydroxide
- Physical state: solid
- Purity: 99,9 % (Wako Pure Chemical)
No further details are given.
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- mammalian cell line, other: human dental pulp cells, designated as D824 cells
- Details on mammalian cell type (if applicable):
- The enzymazically released cells were suspended in alpha-minimum essential medium (alpha-MEM) supplemented with 20 % fetal bovine serum, 100 µM L-ascorbic acid phosphate magnesium salt n-hydrate, 2mM L-glutamine, 0.22 % NaHCO3, 100 units/mL penicilline and 100 µg/mL streptomycin and passed through a 70 µm nylon cell strainer to remove cell aggregates. After counting the number of cells, 1.5x10^5 cells were plated into 75cm² flasks. When confluent, cells were harvested with a solution containing 0.25 % trypsin and 0.1 % EDTA and replated into new flasks.
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- 30; 100 and 300 µM
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Test substance was dissolved at 30 mM in glycerol at 65 °C.
Controlsopen allclose all
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- Cells were treated for 2 hours in the presence of 5% PMS
Migrated to IUCLID6: (50 µM)
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: formalin (0.001 and 0.0003 µM)
- Remarks:
- CA in D824 cells induced by treatment for 30 hours.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 3 hours
- Expression time (cells in growth medium): After treatment, cells were washed twice with fresh medium and subsequently incubated for a further 27-hour period, or cells were treated continuously for 30 hours.
- Fixation time (start of exposure up to fixation or harvest of cells): 3 hours before the end of the incubation, colcemid was administered at 0.02 µg/mL, and metaphase chromosomes were prepared for analysis.
NUMBER OF METAPHASES EVALUATED: 100 to 200
DETERMINATION OF CYTOTOXICITY
- Method: Mitotic index; cloning efficiency; relative total growth; other: Cytotoxicity was measured to select concentrations for analysis of chromosome aberrations. Cytotoxicity was determined as the number of cells treated with calcium hydroxide, relative to the number of cells in the control cultures x 100.
D824 cells after 6 to 8 passages were plated in triplicate onto 60-mm dishes at 8x10³ cells/cm², equivalent to 1.6x10^5 cells/dish, and incubated overnight. The cells were treated with calcium hydroxide (in absence or presence of metabolic activation) at varying concentrations for 3 hours. After two washings with 2 mL of fresh medium, cells were incubated for a further 24 hours and the number of cells was counted after harvesting cells with 0.25% trypsin.
EXAMINATIONS:
The aberrations scored were gaps, breaks, exchanges, dicentric chromosomes, ring chromosomes and fragmentations. - Evaluation criteria:
- No data given
- Statistics:
- Statistical analysis was performed by qui-square test to assess the significance of the difference in the incidences of chromosome aberrations between control cultures and cultures treated with calcium hydroxide. The level of significance in the statistical analysis was determined at p<0.05.
Results and discussion
Test results
- Species / strain:
- mammalian cell line, other: D824 cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- No increases in the levels of chromosome aberrations were observed in cells treated with calcium hydroxide.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Calcium hydroxide did not induce chromosome aberrations after 3 h. Since it is known that some substances induce chromosome aberrations only after longer exposure, a protocol with a continuous treatment for 30 hours was employed additionally. Results show that calcium hydroxide did not enhance the level of chromosome aberrations in D824 cells even after prolonged exposure.
- 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
Calcium hydroxide failed to induce chromosome aberrations in the absence or presence of exogenous metabolic activation.
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