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EC number: 215-200-5 | CAS number: 1312-81-8
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented publication which meets basic scientific principles
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of the potential genotoxicity of the phosphate binder lanthanum carbonate
- Author:
- Damment S.J.P., Beevers C., Gatehouse D.G.
- Year:
- 2 005
- Bibliographic source:
- Mutagenesis 20 (1): 29-37
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- not specified
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Dilanthanum tricarbonate
- EC Number:
- 209-599-5
- EC Name:
- Dilanthanum tricarbonate
- Cas Number:
- 587-26-8
- Molecular formula:
- CH2O3.2/3La
- IUPAC Name:
- Dilanthanum tricarbonate
- Details on test material:
- - Name of test material (as cited in study report): Lanthanum carbonate
- Molecular formula (if other than submission substance): La2(CO3)3
- CAS No: 587-26-8
- Analytical purity: 100.5 %
Constituent 1
Method
- Target gene:
- hprt locus
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver fraction
- Test concentrations with justification for top dose:
- 50, 250, 500, 1000, 1500, and 2000 µg/mL in the absence of S9 mix
25, 250, 500, 2500 and 5000 µg/mL in the presence of S9 mix - Vehicle / solvent:
- - sterile distilled water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: ethyl methane sulphonate (750 µg/mL) in the absence of S9 mix; benzo[a]pyrene (25 µg/mL) in the presence of S9 mix
- Details on test system and experimental conditions:
- DURATION
- Exposure duration: 3 h
- Selection time (if incubation with a selection agent): 7 d
SELECTION AGENT (mutation assays): 6-thioguanine
NUMBER OF REPLICATIONS: 2 independant assays with duplicate cultures
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
- Evaluation criteria:
- - significant increase of mutation frequency
- dose-response relationship - Statistics:
- The significance of any changes in mutation frequency compared with the control was determined using the statistical methods described in Statistical Evaluation of Mutagenicity Test Data (Kirkland, 1989).
Results and discussion
Test resultsopen allclose all
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 2000 µg/mL: experiment I 80 - 90% reduction; experiment II: approx. 38% reduction); 1500 µg/mL: experiment I approx. 35% reduction; experiment II: approx. 54% reduction)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- 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:
- There were no statistically significant effects on mutation frequency in the presence and absence of S9 mix. In the absence of S9 mix increases in mutation frequency were obtained at isolated concentrations in the first experiment. However, these were not statisitcally significant, there was no obvious dose-response relationship and the effects were not reproducible in a second experiment, indicating that they had arisen by chance and do not indicate a mutagenic effect due to lanthanum carbonate.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Maximum revertant colonies, control data and data for cytotoxicity (if observed):
(* p< 0.05; n.d. no data given)
Without S9: experiment I
Conc. (µg/mL) | No. of colonies | control (%) | Mutation frequency (x 10E-6) |
2000 | 21.3 | 16.4 | 11.4 |
1500 | 83.7 | 64.4 | 0.9 |
500 | 128.3 | 98.7 | 16.5 |
solvent control | 130 | 100 | 2.5 |
positive control |
n.d. | n.d. | 574.4* |
Without S9: experiment II
Conc. (µg/mL) | No. of colonies | control (%) | Mutation frequency (x 10E-6) |
2000 | 101.3 | 62.1 | 14 .9 |
1500 | 95.3 | 56.6 | 14.1 |
50 | 147.0 | 90.2 | n.d. |
solvent control | 163 | 100 | 15.5 |
positive control | n.d. | n.d. | 540.9* |
With S9: experiment I:
Conc. (µg/mL) | No. of colonies | control (%) | Mutation frequency (x 10E-6) |
2500 | 144.8 | 125.6 | 6.8 |
solvent control | 115 | 100 | 10.6 |
positive control | n.d. | n.d. | 89.6* |
With S9: experiment II:
Conc. (µg/mL) | No. of colonies | control (%) | Mutation frequency (x 10E-6) |
5000 | 104.7 | 96.3 | 1.5 |
solvent control | 108.7 | 100 | 5.0 |
positive control | n.d. | n.d. | 65.6* |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Lanthanum carbonate was not genotoxic in a mammalian cell HPGRT gene mutation assay using CHO cells up to cytotoxic or maximum recommendedconcentrations both in the pesence and absence of at liver S9 mix. - Executive summary:
Damment et al. (2005) investigated the genotoxic activity of lanathanum carbonate in a HPRT mammalian gene mutation assay in Chinese Hamster Ovary (CHO) cells in accordance with recent guideline requirements. The substance was not genotoxic with and without a metabolic activations system (rat liver S9 mix).
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