Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 227-579-4 | CAS number: 5895-46-5
- 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
A fully compliant OECD 422 study is available, performed using dicerium tricarbonate as the test substance. Reading-across from this similar substance, the study has been considered as the key study for evaluating the repeated dose toxicity of dineodymium tricarbonate.
Repeat dose studies via the dermal and inhalation routes have been waived.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 450 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
The NOEL of 150 mg/kg bw/day for parental toxicity was set, based on microscopic findings in the stomach likely related to portal-of-entry irritating effects. As haematological and/or clinical chemistry changes were observed only in animals treated at 1000 mg/kg bw/day, and there were no other significant effects, the NOAEL for systemic toxicity was 450 mg/kg bw/day.
In accordance with section 1 of annex XI of the REACH regulation, a repeat dose toxicity study via the dermal route does not need to be conducted if the study does not appear to be scientifically necessary. A study conducted to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) already sufficiently addresses the repeat dose toxicity data requirements.
In accordance with section 1 of annex XI of the REACH regulation, a repeat dose toxicity study via the inhalation route does not need to be conducted if the study does not appear to be scientifically necessary. A study conducted to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) already sufficiently addresses the repeat dose toxicity data requirements.
Justification for classification or non-classification
Treatment for at least 28 days in males and approximately 5 -6 weeks in females up to and including 1000 mg/kg bw/day by oral gavage was well tolerated, with no mortality, without any signs of over toxicity, and limited effects on body weight/food consumption.
The NOEL of the study for parental toxicity was set at 150 mg/kg bw/day on the basis of microscopic findings in the stomach detected in males at 450 mg/kg bw/day and in animals of both sexes receiving 1000 mg/kg bw/day. It is considered that these effects were likely related to portal-of-entry irritating effects, due to the high concentrations of the substance given as a bolus by gavage.
On this basis the substance is not classified for repeated dose toxicity.
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