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EC number: 233-238-0 | CAS number: 10099-59-9
- 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
Repeated dose toxicity: oral
Braun (2013) performed a combined repeated dose toxicity study with reproduction/developmental toxicity screening test in rats with the read-across substance lanthanum acetate according to OECD Guideline 422 (GLP). A NOAEL for systemic toxicity of >= 1000 mg/kg bw/day was derived.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity: oral
Braun (2013) performed a combined repeated dose toxicity study with reproduction/developmental toxicity screening test in RccHan: WIST (SPF) rats with the read-across substance lanthanum acetate. Lanthanum acetate was administered to male rats for 46 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum (approximately 49 days).
Animals were exposed at 110, 330 and 1000 mg/kg bw/day dose levels (expressed as anhydrous active ingredient). Control animals were dosed with the vehicle (bi-distilled water) alone.
There were no effects upon mortality of parental animals, no clinical findings (daily or weekly), no differences in the functional observational battery (including grip strength and locomotor activity), no differences in mean absolute or relative organ weights, and no overt macroscopical findings of toxicological relevance.
At 1000 mg/kg bw/day, test-item related effects included reduced mean daily food consumption in males during the initial week of treatment, and in females during the first two weeks of treatment and during the second week of gestation, reduced body weights in males throughout the treatment period and in females intermittently during pre-pairing and gestation.The mean total protein, albumin and globulin levels of the males and females treated with 1000 mg/kg bw/day were significantlyreduced (p<0.01) when compared with the control values. These latter changes were considered to be related to the treatment with the test item. At 330 mg/kg bw/day, reduced total protein, albumin and globulin levels of females were considered to be the only findings of potential toxicological relevance. No changes were reported in males. These changes were considered conclusive but not sufficient for the derivation of a NOAEL value.
Test item related morphological changes were noted in animals treated with 330 and 1000 mg/kg bw/day, and included increased incidence and severity of inflammatory cell infiltration in submucosa to base of lamina propria of the stomach,and considered to be a reactive inflammatory lesion (gastritis) to a repeatedly gavaged test material.The severity was slightly higher in males than females. The inflammatory change was associated with eosinophilic globule leukocytes in mucosa, and sometimes with atrophy of fundic glands, eosinophilic chief cells and epithelial vacuolation ofthe squamous limiting ridge at minimal to slight severity. These changes were considered to be a local effect of the test item rather than one of systemic toxicological relevance.
The NOEL for toxicity of the parent animals was considered to be 110 mg/kg bw/day, based upon the changes in the stomachs of rats treated with 330 and 1000 mg/kg bw/day as well as differences in the mean daily food consumption and mean body weight at 1000 mg/kg bw/day. Although these changes were considered to be related to the treatment with the test item, the morphological changes in the stomachs were considered to be local effects rather than systemic toxicity and the differences in the food consumption/body weight were considered secondary to the changes in the stomach.
Therefore, the NOAEL for systemic toxicity of the parent animals was considered to be >= 1000 mg/kg bw/day (the highest dose tested; limit dose in this type of study).
The read-across justification is added in Section 13 of IUCLID. A maximal reliability score of 2 (reliable with restrictions) is assigned because the study has been used for read-across purposes in this dossier.
Repeated dose toxicity: inhalation
A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation. Furthermore, the substance is hygroscopic and forms aggregates. Therefore this study is not justified.
Repeated dose toxicity: dermal
A key study (read across) is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Read-across study from lanthanum acetate, another 'water-soluble' lanthanum salt. The read-across justification is added in Section 13 of IUCLID
Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
A key study (read-across) is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure. Furthermore, the substance is hygroscopic and forms aggregates. Therefore this study is not justified.
Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
A key study (read-across) is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure. Furthermore, the substance is hygroscopic and forms aggregates. Therefore this study is not justified.
Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
A key study (read- across) is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure.
Justification for selection of repeated dose toxicity dermal - local effects endpoint:
A key study (read across) is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure.
Justification for classification or non-classification
Based on the available data of the read-across substance lanthanum acetate and supporting data on lanthanum trinitrate, and according to the criteria of the CLP Regulation, lanthanum trinitrate should not be classified for STOT repeated exposure via the oral route.
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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