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Diss Factsheets
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EC number: 209-599-5 | CAS number: 587-26-8
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- 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
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of the potential genotoxicity of the phosphate binder lanthanum carbonate
- Author:
- Damment, S.J.P. et al.
- Year:
- 2 005
- Bibliographic source:
- Mutagenesis 20 (1): 29-37
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- three sampling times (24, 48 and 72 h after treatment)
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Dilanthanum tricarbonate
- EC Number:
- 209-599-5
- EC Name:
- Dilanthanum tricarbonate
- Cas Number:
- 587-26-8
- Molecular formula:
- La2(CO3)3
- IUPAC Name:
- dilanthanum tricarbonate
- Details on test material:
- - Name of test material (as cited in study report): Lanthanum carbonate
- Analytical purity: 100.5% w/w
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - carboxymethylcellulose, 0.5% w/v
- Duration of treatment / exposure:
- 24, 48 and 72 h after treatment groups of animals were killed and bone marrow smears were prepared.
- Frequency of treatment:
- single dose
Doses / concentrations
- Remarks:
- Doses / Concentrations:
800, 1250 and 2000 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - Mitomycin C
- Route of administration: i.p.
- Doses / concentrations: 4 mg/kg
Examinations
- Tissues and cell types examined:
- After staining, the incidence of micronuclei was scored in polychromatic erythrocytes (2000/mouse) and the ratio of polychromatic to normochromatic cells was also determined from a sample of 1000 total cells.
- Evaluation criteria:
- Clear increase in the number of micronucleated cells in a single dose group at a single sampling time.
- Statistics:
- Statistical analysis was performed using the statistical methods described in Statistical Evaluation of Mutagenicity Test Data (Kirkland, 1989).
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- In the mouse bone marrow micronucleus assay after oral administration of lanthanum carbonate all treatment and vehicle control groups exhibited normal frequencies of micronucleated polychromatic erythrocytes (MNPCE), with the exception of the vehicle control group (male mice) sampled at 48 h. In this group there was a complete absence of micronuclei for all of the five animals analysed. This resulted in statistically significant differences being recorded for the mean MNPCE in the male groups sampled at 48 h after doses of 1250 and 2000 mg/kg bw. For these two groups the MNPCE frequencies fell well within the historical control range for this strain of mouse. Consequently, this result was not considered to be biologically relevant and was the result of the unusually low micronucleus frequency recorded for the control animals at this sample time.
It can be concluded that lanthanum carbonate does not induce micronuclei in mouse bone marrow after administration of doses up to the maximum practicable oral dose of 2000 mg/kg bw.
Any other information on results incl. tables
MNPCE: micronucleated polychromatic erythrocytes
PCE: polychromatic erythrocytes
NCE: normochromatic erythrocytes
Geometric mean frequency MNPCE and mean PCE/NCE ratio:
Males
concentration (mg/kg) |
MNPCE |
MNPCE |
MNPCE |
mean PCE/NCE ratio (%) |
mean PCE/NCE ratio (%) |
mean PCE/NCE ratio (%) |
|
24 h |
48 h |
72 h |
24 h |
48 h |
72 h |
vehicle control |
1.49 |
0.00 |
0.64 |
115 |
101 |
89 |
800 |
0.97 |
0.64 |
1.61 |
81 |
77 |
125 |
1250 |
1.35 |
1.05* |
1.40 |
92 |
134 |
96 |
2000 |
0.25 |
1.17* |
1.27 |
98 |
134 |
91 |
positive control |
88.7** |
|
|
91 |
|
|
*: p < 0.05 (Dunnetts test)
**: p < 0.001 (Student´s test)
Females
concentration (mg/kg) |
MNPCE |
MNPCE |
MNPCE |
mean PCE/NCE ratio (%) |
mean PCE/NCE ratio (%) |
mean PCE/NCE ratio (%) |
|
24 h |
48 h |
72 h |
24 h |
48 h |
72 h |
vehicle control |
3.28 |
2.10 |
0.15 |
91 |
114 |
145 |
800 |
2.13 |
1.93 |
1.17 |
119 |
130 |
208 |
1250 |
1.93 |
1.70 |
0.52 |
97 |
121 |
229 |
2000 |
0.89 |
1.86 |
1.17 |
114 |
204 |
181 |
positive control |
75.1* |
|
|
91 |
|
|
*: p < 0.001 (Student´s test)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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