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EC number: 215-277-5 | CAS number: 1317-61-9
- 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
Two reliable studies for oral toxicity were evaluated. In an acute inhalation toxicity study rats were exposed to a concentration of 640mg/m³ (maximum attainable concentration) Fe3O4 nanoparticles. None of the animals died. In an additional acute inhalation toxicity study with Fe2O3 as a surrogate for the iron oxide group the discriminating dose was 5050 mg/m³.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Full report available; non GLP study
- Principles of method if other than guideline:
- Single oral application per gavage. Observation period: 14 days. The test substance was applied in water/chremophor
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- other: water + Cremophor
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Clinical signs:
- other:
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Executive summary:
Rats were dosed with 5000 mg/kg bw of test substance. Neither symptoms nor mortality were observed.
Reference
A single dose of 5000 mg/kg bw was tolerated by all male and female animals without any reaction
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- scientifically acceptable and well documented
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable and well documented
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Principles of method if other than guideline:
- In this study, the toxicity responses of rat following a continuous 4 h inhalation exposure of only the head and nose to iron oxide nanoparticles (Fe3O4 NPs, size = 15–20 nm) was investigated. The rats for the investigation were exposed to a concentration of 640mg/m³ (maximum attainable concentration) Fe3O4NPs.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- air
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 640 mg/m³ (maximum attainable concentration)
- No. of animals per sex per dose:
- 18 male and 18 female animals/dose
- Control animals:
- yes
- Sex:
- male/female
- Dose descriptor:
- discriminating conc.
- Effect level:
- > 640 mg/m³ air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: 640 mg/m³ = maximum attainable concentration
- Executive summary:
In this study, the toxicity responses of rat following a continuous 4 h inhalation exposure of only the head and nose to iron oxide nanoparticles (Fe3O4 NPs, size = 15–20 nm) was investigated. The rats for the investigation were exposed to a concentration of 640mg/m³ (maximum attainable concentration) Fe3O4NPs.
The results showed a significant decrease in the cell viability, with the increase in the levels of lactate dehydrogenase, total protein, and alkaline phosphatase in the BALF. Total leukocyte count and the percentage of neutrophils in BALF increased within 24 h of postexposure. Immediately following acute exposure, rats showed increased inflammation with significantly higher levels of lavage and blood proinflammatory cytokines and were consistent throughout the observation period. Fe3O4 NPs exposure markedly increased malondialdehyde concentration, while intracellular reduced glutathione and antioxidant enzyme activities were significantly decreased in lung tissue within 24-h postexposure period. On histological observation, the lung showed an early activation of pulmonary clearance and a size-dependant biphasic nature of the Fe3O4NPs in causing the structural alteration.Collectively, the data illustrate that Fe3O4NPs inhalation exposure may induce cytotoxicity via oxidative stress and lead to biphasic inflammatory responses inWistar rat.
Reference
The results showed a significant decrease in the cell viability, with the increase in the levels of lactate dehydrogenase, total protein, and alkaline phosphatase in the BALF. Total leukocyte count and the percentage of neutrophils in BALF increased within 24 h of postexposure. Immediately following acute exposure, rats showed increased inflammation with significantly higher levels of lavage and blood proinflammatory cytokines and were consistent throughout the observation period. Fe3O4 NPs exposure markedly increased malondialdehyde concentration, while intracellular reduced glutathione and antioxidant enzyme activities were significantly decreased in lung tissue within 24-h postexposure period. On histological observation, the lung showed an early activation of pulmonary clearance and a size-dependant biphasic nature of the Fe3O4NPs in causing the structural alteration.Collectively, the data illustrate that Fe3O4NPs inhalation exposure may induce cytotoxicity via oxidative stress and lead to biphasic inflammatory responses inWistar rat.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 640 mg/m³ air
- Quality of whole database:
- scientifically acceptable and well documented
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In 2 reliable acute toxicity studies rats received per gavage doses of 10000 or 5000 mg/kg bw of the test substance. Neither symptoms nor mortality were observed. Therefore the LD50 is > 5000 mg/kg bw. Rats exposed to 640 mg/m³ (maximum attainable concentration) revealed not death. In an additional acute inhalation toxicity study with Fe2O3 as a surrogate for the iron oxide group the discriminating dose was 5050 mg/m³. No study for acute dermal toxicity is available. Due to its structure and physico-chemical properties (insoluble in water and organic solvents) no systemic bioavailability is expected.
Justification for selection of acute toxicity – oral endpoint
key study used
Justification for selection of acute toxicity – inhalation endpoint
key study used
Justification for classification or non-classification
In 2 reliable acute toxicity studies rats received per gavage doses of 10000 or 5000 mg/kg bw of the test substance. Neither symptoms nor mortality were observed. Therefore the LD50 is > 5000 mg/kg bw. Rats exposed to 640 mg/m³ (maximum attainable concentration) revealed no death. In an additional acute inhalation toxicity study with Fe2O3 as a surrogate for the iron oxide group the discriminating dose was 5050 mg/m³.
Due to the insolubility of Fe3O4 dermal absorption seems not to be a route of an appreciable incorporation of insoluble iron oxides. This fact is supported by the low oral and inhalation toxicity.No classification is required.
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