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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
Carcinogenicity
Administrative data
Description of key information
There is no evidence, that the substance is carcinogenic. Lanthanum carbonate does not carry any structures suggesting a carcinogenic potency. Moreover, the results of the perfomed in vitro and in vivo genotoxicity studies were negative indicating that carcinogenicity by a direct genotoxic mechanism can be excluded. Finally, in the repeated dose toxicity studies, there was no evidence for pre-neoplastic lesions.
Key value for chemical safety assessment
Justification for classification or non-classification
The data on carcinogenicity by the oral route is conclusive but not sufficient for classification according to the criteria of Directives 67/548/EEC (DSD) and 1272/2008/EC (CLP).
Additional information
In a carcinogenicity study - only available as short abstract - rats were given daily up to 1500 mg/kg bw/day Lanthanum III carbonate hydrate by gavage for 104 weeks (Läkemedelsverket, 2006). In this study the NOAEL regarding carcinogenicity was considered to be 1500 mg/kg bw/day. This was based on the fact that no increased incidences of malignant tumours were observed. Although some histocytic sarcomas in a few rats were found, these were regarded as of spontaneous origin rather than induced by Lanthanum carbonate.
In a similar study CD-1 mice were treated orally with up to 1500 mg/kg bw/d Lanthanum III carbonate hydrate for 2 years (Läkemedelsverket, 2006). No increased incidences of malignant tumours were observed although there was a dose-dependent increase in the incidence and severity of non-neoplastic lesions in the stomach. These lesions progressed to benign gastric adenoma in four high-dose males and one high-dose female. However, these findings were considered to be related to an exacerbation of spontaneous pathological stomach changes in CD-1 mice since it is known that aging CD-1 mice are predisposed to the development of sponataneous adenomatous hyperplasia. Adenomatous hyperplasie was also seen in control mice and the hyperplastic lesions in treated mice showed no atypical cytological alterations suggestive of pre-malignancy.
No gastric mucosal changes were seen in long-term dog studies (Läkemedelsverket, 2006). The positive finding only in a particularly sensitive mouse strain and negative findings in rats (hyperplasia but no tumours) and dogs (no hyperplasia) indicate that the neoplastic response in the mouse has little toxicological significance.
Moreover, based on the observations in the subchronic feeding study with Lanthanum carbonate octahydrate performed according to OECD 408 (Reißmüller, 2006) there is no indication of treatment-related histopathological changes since observations occurred at a comparable frequency and severity grade among control and animals treated with up to and including 1480.4 mg/kg bw/day for 90 days in the diet.
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