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EC number: 237-898-0 | CAS number: 14059-33-7
- 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Bismuth vanadium tetraoxide
- EC Number:
- 237-898-0
- EC Name:
- Bismuth vanadium tetraoxide
- Cas Number:
- 14059-33-7
- Molecular formula:
- Bi O4 V
- IUPAC Name:
- vanadium(5+) bismuth(3+) tetraoxidandiide
- Details on test material:
- - Name of test material (as cited in study report): Mix 1:1 Irgacolor Yellow 14247/Sicopal Yellow L 1100
- Physical state: solid
- Analytical purity: 84.8 %, according to certificate of re-analyis in 1993
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- other: unchanged (no vehicle)
- Remarks on MMAD:
- MMAD / GSD: < 1.2 µm
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- 6 hours/working day
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.1 mg/m³ air (analytical)
- Dose / conc.:
- 0.7 mg/m³ air (analytical)
- Dose / conc.:
- 4 mg/m³ air (analytical)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent no treatment
Examinations
- Observations and examinations performed and frequency:
- Clinical examination was performed once each working day during the pre-flow period and on the day of necropsy. On exposure days, findings were recorded before, during, and after exposure. Body weight of the animals was determined weekly. Ophthalmology was carried out prior to the exposure period in all animals and at the end of exposure in the high concentration group and control.
- Sacrifice and pathology:
- A complete necropsy including weighing of selected organs and gross-pathological evaluation was performed in all animals. Histopathology of the total respiratory tract was performed in control and high concentration animals in the mid and low concentration. Only lungs and mediastinal lymph nodes were examined. Additionally, all gross lesions were examined. Bismuth and vanadium contents in five left lungs/concentration were determined analytically and lung burdens of CIP were calculated.
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOAEC
- Effect level:
- 0.1 mg/m³ air (analytical)
- Sex:
- male/female
- Basis for effect level:
- histopathology: non-neoplastic
- Dose descriptor:
- LOAEC
- Effect level:
- 0.7 mg/m³ air (analytical)
- Sex:
- male/female
- Basis for effect level:
- histopathology: non-neoplastic
- organ weights and organ / body weight ratios
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
In neither concentration clinical symptoms or an influence on body weight development occurred.
The pigment content of the lungs at the end of the study can be found in the following table:
Pigment content [mg/lung] |
Dose Group[mg/m3] | |
male |
female |
|
-- |
-- |
-- |
0.033 |
0.021 |
0.1 |
0.36 |
0.28 |
0.7 |
1.82 |
1.51 |
4.0 |
The following substance-related findings were detected
during pathological examination:
High concentration (4 mg/m3) and mid concentration
(0.7 mg/m3)
- Significant increase of absolute (222 - 248% or 171 - 175%) and relative (228 - 241% or 171 - 183%) lung weights
- Foci in the lungs mainly due to the alveolar proteinosis and enlarged mediastinal lymph nodes in all or most of the animals
- Aggregates of (partly disintegrated) foamy alveolar macrophages, without substance, multifocal, deep in the lung parenchyma and subpleural in males and females
- Alveolar and septal macrophages containing birefringent test substance in male and female rats
- Birefringent test substance in the Bronchus Associated Lymphoid Tissue (BALT) in male and female rats
- Alveolar proteinosis containing birefringent test substance in male and female animals, more severe at the high concentration (4 mg/m3)
- Hyperplasia of type II pneumocytes, multifocal in males
and females
- collagenization, perivascular and peribronchial, minimal in males and females
- cholesterol crystals (only in one male animal of group 3 and one female animal of group 2) as secondary product of disintegrated alveolar macrophages
- Marked focal squamous cell metaplasia (only in one female animal of group 3)
- residues of birefringent substance intrabronchial in males and females of both groups, intratracheal and in the larynx in males and females of group 3 (without structural organ changes)
- Substance storage in mediastinal lymph nodes and lymphoreticular hyperplasia in males and females
Low concentration (0.1 mg/m3)
- No changes of toxicological significance.
Applicant's summary and conclusion
- Conclusions:
- The high and mid concentration led to considerable toxic effects exclusively to the lung. No systemic toxicity was observed based on clinical and necropsy findings.
The low concentration of 0.1 mg/m3 is judged to be a "No Observed Adverse Effect Concentration" (NOAEC), because there were no histopathological changes in the target organ.
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