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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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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:
- Systemic lanthanum is excreted in the bile of rats
- Author:
- Damment, S.J.P. and Pennick, M.
- Year:
- 2 007
- Bibliographic source:
- Toxicology Letters 171: 69-77
Materials and methods
- Objective of study:
- toxicokinetics
- Principles of method if other than guideline:
- Following single oral gavage the plasma lanthanum concentration was determined in rats at different time intervalls.
- GLP compliance:
- not specified
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): Lanthan carbonate
- Molecular formula (if other than submission substance): [La2(CO3)3·4H2O]
- Analytical purity: no data
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd. (Margate, UK) or Harlan UK Ltd. (Bicester, UK).
- Weight at study initiation: 165-253 g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Lanthanum carbonate was suspended in 0.5% (w/v) carboxymethyl cellulose for oral administration. - Duration and frequency of treatment / exposure:
- single dose
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1500 mg/kg (765 mg/kg elemental lanthanum)
- No. of animals per sex per dose / concentration:
- 3 animals per sex, per time point
- Control animals:
- yes, concurrent vehicle
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: blood, plasma
- Time and frequency of sampling: pre-dose, and at 1, 2, 4, 8, 12, 24, 48 and 72 h after administration
PREPARATION OF BLOOD/PLASMA
- Blood was centrifuged and plasma separated and diluted with tetramethyl ammonium hydroxide (TMAH) solution (1.25% [w/v] containing 0.1% [w/v] ethylenediaminetetraacetic acid diammonium salt [EDTA (NH4)2] as a lanthanum chelator). Lanthanum content was determined using an Agilent (Hewlett Packard) 4500 inductively coupled plasma (ICP)-mass spectrometer fitted with a Babington V-groove nebulizer and a glass spray chamber (Scott double pass cooled to 2 °C).
- The lower limit of quantification was 0.05 ng/mL. - Statistics:
- Pharmacokinetic parameters were derived from plasma lanthanum concentrations by visual inspection of the individual or mean plasma concentration curves or by non-compartmental analysis using WinNonlin® (Version 3.0, Pharsight Corporation, Mountain View, California).
The observed maximum plasma lanthanum concentration (Cmax) and the time post-dose at which Cmax occurred (Tmax) were determined by visual inspection of individual or mean plasma concentration versus time curves. The area under the plasma concentration versus time curves, calculated from time 0 to 24 h post-dose (AUC0–24), and from time 0 to the last sample collection time (AUClast) were calculated using linear trapezoidal summation from time 0 to the appropriate time point.
The absolute bioavailability (percentage of the administered oral dose absorbed) was calculated from the equation, F = (AUC 0–24PO/Dose PO)/(AUC0–24 IV/Dose IV)×100.
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- After a 1500 mg/kg oral dose of lanthanum carbonate Cmax was 1.04±0.31 ng/mL with a Tmax of 8 h. Thereafter, plasma lanthanum levels decreased to 0.11±0.04 ng/mL at 72 h.
Calculation of absolute oral bioavailablity: 0.0007%
Toxicokinetic parametersopen allclose all
- Test no.:
- #1
- Toxicokinetic parameters:
- Cmax: 1.04+/-0.31 ng/mL
- Test no.:
- #1
- Toxicokinetic parameters:
- AUC: 0-24 h: 15.08 ng*h/mL
Metabolite characterisation studies
- Metabolites identified:
- not measured
Applicant's summary and conclusion
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.
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