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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
Health surveillance data
Administrative data
- Endpoint:
- health surveillance data
- Type of information:
- experimental study
- 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:
- Long-Term Efficacy and Tolerability of Lanthanum Carbonate: Results from a 3-Year Study
- Author:
- Hutchison, A. J. et al.
- Year:
- 2 006
- Bibliographic source:
- Nephron Clin Pract 102: c61-c71
Materials and methods
- Study type:
- human medical data
- Endpoint addressed:
- repeated dose toxicity: oral
- Principles of method if other than guideline:
- Six months and 2-year extensions to a 6-month study evaluated the long-term safety, tolerability and efficacy of the phophate binder lanthanum carbonate.
- 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): lanthanum carbonate
- Analytical purity: no data
Constituent 1
Method
- Details on study design:
- This open-label extension to the previous 6-month comparator-controlled trial consisted of two parts. The first part was a 6-month extension carried out at 67 centers in the UK, Germany and Belgium, and the Netherlands.
The second was a 2-year extension carried out at 34 of these centers in the UK, Germany and Belgium, and was initiated at the request of investigators and patients who participated in the previous phases of the study.
The design of the original comparator-controlled trial has been reported in [Hutchison 2005, Nephron Clin Pract 100: c8-c19].
Results and discussion
- Results:
- Mean serum phosphate was ~1.80 mmol/L throughout the trial. The percentage of patients with controlled serum phosphate (<= 1.80 mmol/L) after the 6-month extension was 63.3 and 58.4% in the continued-lanthanum and switch groups, respectively; after the 2-year extension, 54.4% of patientshad controlled serum phosphate. After discontinuation of calcium carbonate and initiation of lanthanum carbonate, the hypercalcemia incidence was 2.7%, compared with 20.2% during the double-blind phase. Calcium phosphate product was maintained at an acceptable level. Lanthanum carbonate was well tolerated; adverse events were mild and mainly gastrointestinal.
Importantly, there was no evidence of an increase in the frequency of adverse events previously associated with traditional phosphate-binder treatment, such as hypercalcemia, microcytic anemia, fractures or bone pain. The fact that 46 patients (the long-term-exposure group) were able to continue receiving lanthanum carbonate treatment with no unexpected adverse events anticipated in the long-term.
Applicant's summary and conclusion
- Conclusions:
- Lanthanum carbonate maintains effectiveness with continued tolerability for up to 3 years.
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