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Diss Factsheets
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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
Endpoint summary
Administrative data
Description of key information
In a 90-day dietary study with lanthanum carbonate in rats no treatment related adverse effects were obseved up to the highest dose tested (14000 ppm or 974 mg/kg bw/d for males and 1480 mg/kg bw/day for females) corresponding to a NOAEL > 525 mg/kg bw/d for males and > 799 mg/kg bw/day for females based on Lanthanum oxide.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- Study duration:
- subchronic
- Species:
- rat
Additional information
Repeated dose toxicity summary
No study is available for Lanthanum oxide. For the analogous substance lanthanum carbonate a reliable 90-day oral feeding study (according to OECD guideline 408 and under GLP) has been conducted. Due to the comparably low water solubility of the two substances, supported by the available toxicokinetic information this study can reasonably be used for the assessment of lanthanum oxide as well. Further studies on lanthanum oxide are therefore not regarded as scientifically necessary and are not recommended under animal protection considerations.
Oral
Repeated dose toxicity was analyzed in a reliable subchronic feeding study with Lanthanum carbonate octahydrate performed under GLP according to OECD guideline 408. Groups of five male and female Wistar rats received nominal doses of 1400, 2400 and 14000 ppm for 90 days in the diet. In addition to the guideline protocol neurobehavioral tests as well as immunotoxicological examinations were performed in satellite groups. With the exception of single incidental findings no treatment- related adverse effects were observed. Therefore, the NOAEL was found to be 14000 ppm Lanthanum carbonate octahydrate corresponding to 6440 ppm Lanthanum or 7553 ppm La2O3. Based on the daily food consumption the NOAEL based on lanthanum carbonate was ≥ 974 mg/kg bw/d for males (448 mg La/kg bw/d, or 525 mg/kg bw/d La2O3) and ≥ 1480 mg/kg bw/d for females (681 mgLa/kg bw/d or 799 mg/kg bw/d La2O3) respectively, i.e. greater than the highest dose tested in the study.
Justification for classification or non-classification
Based on a NOAEL of > 525 mg/kg bw/day calculated as La2O3, with no treatment related effects observed in a 90 -day dietary study in rats with the analogous substance lanthanum carbonate, no classification for repeated dose toxity is warranted.
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