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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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 108.9 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: Please refer to Eurometaux publication which is attached to this dossier.
- Overall assessment factor (AF):
- 6
- Dose descriptor starting point:
- NOAEL
- Value:
- 741 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 653.3 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The DNELs for the long-term exposure are derived from the no observed effect level obtained in an oral repeated dose toxicity study with Lanthanum carbonate octahydrate. Since no substance-related effects were noted, a NOAEL of 974 mg/kg bw/day was estimated after treatment for 90 days corresponding to 741 mg/kg bw/day Lanthanum carbonate (Reißmüller, 2006). For calculation of the DNEL for long-term inhalative systemic effects, an allometric scaling has to be applied to take into account route-to-route extrapolation as well as the interspecies difference between rat and human. Therefore, the no observed effect level has to be corrected by 1/0.38 and 6.7/10 regarding respiratory volume and frequency. Further a difault factor of 2 is applied for oral-to-inhalation extrapolation, assuming a worst case scenario according to R 8.4.2 (oral bioavailability < 0.002). Thus, the corrected starting point for workers was 653.3 mg/m³ bw/day for inhalation exposure.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on a sub-chronic study in rats over a time period of 90 days.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not applicable for inhalation route.
- AF for other interspecies differences:
- 1
- Justification:
- No additional factor for chemical-specific remaining uncertainties is applied.
- AF for intraspecies differences:
- 3
- Justification:
- The appropriateness of the applied assessment factors is justified in the attached document and under additional information on workers.
- AF for the quality of the whole database:
- 1
- Justification:
- DNEL is based on a high-quality study.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 123.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: Please refer to Eurometaux publication which is attached to this dossier.
- Overall assessment factor (AF):
- 6
- Dose descriptor starting point:
- NOAEL
- Value:
- 741 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The DNELs for the long-term exposure are derived from the no observed effect level obtained in an oral repeated dose toxicity study with Lanthanum carbonate octahydrate. Since no substance-related effects were noted, a NOAEL of 974 mg/kg bw/day was estimated after treatment for 90 days corresponding to 741 mg/kg bw/day Lanthanum carbonate (Reißmüller, 2006). For the derivation of the sytemic dermal DNEL a correction of the starting point is not required. Subsequently, following assessment factors are taken into account for the DNEL calculation: intraspecies differences (3), exposure duration (2). As a consequence, the resulting DNEL for long-term dermal systemic effects of Lanthanum carbonate is 123.5 mg/kg bw/day for workers.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on a sub-chronic study in rats over a time period of 90 days.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No assessment factor for interspecies differences considered.
- AF for other interspecies differences:
- 1
- Justification:
- No assessment factor for interspecies differences considered.
- AF for intraspecies differences:
- 3
- Justification:
- The appropriateness of the applied assessment factors is justified in the attached document and under additional information on workers.
- AF for the quality of the whole database:
- 1
- Justification:
- DNEL is based on a high-quality study.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Lanthanum carbonate, the salt formed by lanthanum(III) cations and carbonate anions, is used in industry in lanthanum chemistry e.g. as a catalyst.
Therefore, dermal and inhalative intakes are the possible exposure routes for worker.
Together with the fact that no substance-related local effects could be determined, only the DNEL for long-term systemic effects are derived.
The DNELs for the long-term exposure are derived from the no observed effect level obtained in an oral repeated dose toxicity study with Lanthanum carbonate octahydrate. Since no substance-related effects were noted, a NOAEL of 974 mg/kg bw/day was estimated after treatment for 90 days corresponding to 741 mg/kg bw/day Lanthanum carbonate (Reißmüller, 2006).
The assessment factors applied were chosen on the basis of a recent publication by Eurometaux which is attached to this dossier.
For calculation of the DNEL for long-term inhalative systemic effects, an allometric scaling has to be applied to take into account route-to-route extrapolation as well as the interspecies difference between rat and human. Therefore, the no observed effect level has to be corrected by 1/0.38 and 6.7/10 regarding respiratory volume and frequency. Thus, the corrected starting point for workers was 653.3 mg/m³ bw/day for inhalation exposure.
Subsequently, the assessment factors are listed, which have to be taken into account for the calculation of the inhalation DNEL: intraspecies differences (3), exposure duration (2).
Thus, the resulting DNEL for long-term inhalative systemic effects of Lanthanum carbonate is 108.9 mg/m³ for workers.
For the derivation of the sytemic dermal DNEL a correction of the starting point is not required.
Subsequently, following assessment factors are taken into account for the DNEL calculation: intraspecies differences (3), exposure duration (2).
As a consequence, the resulting DNEL for long-term dermal systemic effects of Lanthanum carbonate is 123.5 mg/kg bw/day for workers.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
Lanthanum carbonate is used in industrial settings only. The substance is used as an intermediate in catalysts. In some instances substance or a derivative will be incorporated into the matrix of the catalyst produced. The substance wil not be part of the final product of the catalysed reaction. Therefore, DNELs for consumers or the general population are not relevant.
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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