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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
Health surveillance data
Administrative data
- Endpoint:
- health surveillance data
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting 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:
- Absolute Bioavailability and Disposition of Lanthanum in Healthy Human Subjects Administered Lanthanum Carbonate
- Author:
- Pennick, M. et al.
- Year:
- 2 006
- Bibliographic source:
- J. Clin. Pharmacol., 46:738-746
Materials and methods
- Study type:
- medical monitoring
- Endpoint addressed:
- basic toxicokinetics
- Principles of method if other than guideline:
- Randomized, open-label, parallel-group, phase I study conducted to investigate absolute bioavailability and excretory routes for systemic lanthanum in healthy subjects.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Lanthanum chloride, anhydrous
- EC Number:
- 233-237-5
- EC Name:
- Lanthanum chloride, anhydrous
- Cas Number:
- 10099-58-8
- Molecular formula:
- Cl3La
- IUPAC Name:
- lanthanum trichloride
- Details on test material:
- - Name of test material (as cited in study report): Lanzhanum chloride
- Analytical purity: no data
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed, but no further information available
- Remarks:
- The final protocol and subject-informed consent documentation were approved by the Ravenscourt Ethics Committee (UK) prior to the start of the study
- Details on study design:
- Refer to any other information on materials and methods.
Results and discussion
- Results:
- Lanthanum chloride infusion was well tolerated. The mean ± SD plasma concentration of lanthanum increased from a baseline of < 0.05 ng/mL to a maximum of 5.1 ± 0.9 ng/mL at 3.3 ± 0.8 hours after the start of the infusion. Plasma lanthanum concentrations subsequently declined triphasically, with a mean ± SD terminal elimination half-life of 37 ± 22 hours (range 15-77 hours). Lanthanum plasma exposure (mean ± SD, AUC) after intravenous dosing was 38.9 ± 10.5 ng h/mL. The total clearance of lanthanum (55 ± 16 mL/min) was low relative to average hepatic blood flow (1470 mL/min). Lanthanum was widely distributed after infusion, with an apparent volume of distribution of 164 ± 84 L. Intravenous administration confirmed low renal clearance (0.95 ± 0.60 mL/min), just 1.7% of total plasma clearance. Fecal lanthanum excretion was not quantifiable after intravenous administration owing to high and variable background fecal lanthanum and constraints on the size of the intravenous dose.
Lanthanum was poorly absorbed after oral administration of lanthanum carbonate. A mean Cmax of 0.32 +- 0.13 ng/mL was reached at 4.5 +- 0.8 h after dosing. Thereafter lanthanum concentrations declined bi- or triphasically. The mean terminal elimination half-life was 35 +- 12 hours (range 16 to 48 hours). Lanthanum plasma concentrations were generally blow the limit of quatification from 48 h after administration of the substance. The terminal elimination half-life is therefore to be treated with caution and may well be shorter. The AUC was 3.9 +- 2.5 ng h/mL indicating a low oral availability. Mean bioavailabilty was calculated to be 0.00127 +- 0.00080% (range: 0.00015 to 0.00224%) after oral adminsitration of Lanthanum carbonate. 313 +- 338 ng of lanthanum was ecreted inthe urine within 48 h after dosing representing 0.000031 +- 0.000034% of the dose. Renal clearance was 1.36+- 1.43 mL/min.
Any other information on results incl. tables
Summary of pharmacokinetic parameters
Parameter |
i.v dose (N=8) |
Oral dose (N=8) |
Cmax (ng/mL) |
5.07 +- 0.95 |
0.320 +- 0.133 |
T max (h) |
3.30 +- 0.77 |
4.50 +- 0.756 |
AUC0-t (ng h/mL) |
36.90+-9.85 |
3.90 +- 2.45 |
AUC0-∞(ng h/mL) |
38.90 +- 10.50 |
4.79 +- 3.451 |
T1/2 (h) |
37.4 +- 22.02 |
34.50 +- 12.02 |
ClT(mL/min) |
55.0 +- 15.50 |
- |
Vz (L) |
164.0 +- 83.80 |
- |
Aeu (ng) |
2105.0 +- 1295.0 |
313.0 +- 338.03 |
% of dose in urine |
1.75 +- 1.08 |
0.000031 +- 0.000034 |
CLR(mL/min) |
0.95 +- 0.60 |
1.36 +- 1.433 |
CLR(as % of CL) |
1.73 +- 1.10 |
- |
F (%) |
- |
0.00127+- 0.00080 |
1n= 3 , extrapolated tail area was > 20% of the total area in 5 subjects extrapolation therefore not reliable.
2due to low plasma levels half lives were determined over a time period that was lss than twice this value.
3N=7
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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