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Diss Factsheets
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EC number: 949-084-9 | CAS number: -
- 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
Some treatment related effects, but toxicological significance not possible to determine.
Vanadium detected in kidneys with some accumulation; the highest concentrations were found in the highest test group.
This suggests some elimination, but potential for local (perhaps temporary?) accumulation.
The authors suggest that the top group showed adverse effect, with possible accumulation and changes in chemistry. However, in a one-generation reproduction study, ca 50 mg/kg/day was tolerated for up to 70 day exposure.
A NOAEL of 12 mg/kg/day is proposed based on this study and is used to estimate DNELs.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 90 days
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Sodium metavanadate was used for testing. This is accepted as a reliable source of water-soluble vanadium with dissociation under the acidic conditions of the stomach.
Vanadyl oxysulphate will also dissociate under acidic conditions and safety assessment base don exposure to soluble vandaium ions is considered acceptable for this assessment. - Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Principles of method if other than guideline:
- Substance applied in drinking water
- GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- Sodium vanadate was used for testing. This is accepted as a reliable source of water-soluble vanadium with dissociation under the acidic conditions of the stomach.
Vanadyl oxysulphate will also dissociate under acidic conditions and safety assessment base don exposure to soluble vandaium ions is considered acceptable for this assessment. - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- Dose levels checked by monitoring water consumption and body weights.
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Continiuos in drinking water
- Dose / conc.:
- 0 mg/L drinking water
- Dose / conc.:
- 5 mg/L drinking water
- Dose / conc.:
- 10 mg/L drinking water
- Dose / conc.:
- 50 mg/L drinking water
- No. of animals per sex per dose:
- 10 (males)
- Control animals:
- yes, concurrent vehicle
- Observations and examinations performed and frequency:
- Clinical observations including body weights.
Food consumption determined and mean daily diet consumption calculated
Body weight gain calculated
Blood chemistry checked
URINALYSIS: Yes
- Metabolism cages used for collection of urine: Yes
- Parameters checked: volume excreted - Sacrifice and pathology:
- Gross necropsy and pathology conducted after termination.
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Changes in levels of total protein, with significant increase in top group along with increase in urea.
Not considered to be an adverse effect
Vanadium detected in kidneys with some accumulation; the highest concentrations were found in the highest test group.
This suggests some elimination, but potential for local (perhaps temporary?) accumulation. - Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Minor lesions on kidneys, lung and spleen in all groups, but more evident in highest treatment groups.
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
- Dose descriptor:
- LOEL
- Effect level:
- ca. 50 mg/L drinking water
- Based on:
- test mat.
- Remarks:
- Sodium metavanadate
- Sex:
- male
- Basis for effect level:
- clinical biochemistry
- Dose descriptor:
- LOEL
- Effect level:
- ca. 8.21 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks:
- Sodium metavanadate
- Sex:
- male
- Basis for effect level:
- clinical biochemistry
- Dose descriptor:
- LOEL
- Effect level:
- ca. 3.45 mg/kg bw/day (nominal)
- Based on:
- element
- Remarks:
- Vanadium
- Sex:
- male
- Basis for effect level:
- clinical biochemistry
- Key result
- Dose descriptor:
- LOEL
- Effect level:
- ca. 12 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks:
- Vanadyl oxysulphate
- Sex:
- male
- Basis for effect level:
- clinical biochemistry
- Remarks on result:
- other: Effect level estimated
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 12 mg/kg bw/day (nominal)
- System:
- other: Blood changes; cause not found
- Organ:
- blood
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
- Conclusions:
- Some treatment related effects, but toxicological significance not possible to determine.
Vanadium detected in kidneys with some accumulation; the highest concentrations were found in the highest test group.
This suggests some elimination, but potential for local (perhaps temporary?) accumulation.
The authors suggest that the top group showed adverse effect, with possible accumulation and changes in chemistry. However, in a one-generation reproduction study, ca 50 mg/kg/day was tolerated for up to 70 day exposure.
A NOAEL of 12 mg/kg/day is proposed based on this study and is used to estimate DNELs.
Reference
Treatment levels based on drinking water concentration have been converted using reported consumption levels and body weights.
A molecular weight for sodium metavanadate of 122 has been used to convert to vanadium and then on to the registered substance, using a nominal molecular weight of 173 for vanadyl oxysulphate.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 12 mg/kg bw/day
Additional information
Justification for classification or non-classification
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.