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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
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:
- other: Guideline study - very well documented
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Triiron tetraoxide
- EC Number:
- 215-277-5
- EC Name:
- Triiron tetraoxide
- Cas Number:
- 1317-61-9
- Molecular formula:
- Fe3O4
- IUPAC Name:
- Iron oxide
- Test material form:
- solid: pressed powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: unchanged (no vehicle)
- Remarks on MMAD:
- MMAD / GSD: MMAD was 1.3 µm, GDS ~2
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 6 hours/day 5 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
4.7, 16.6, 52.1 mg/m³
Basis:
analytical conc.
- No. of animals per sex per dose:
- 20
- Control animals:
- yes
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 4.7 mg/m³ air
- Sex:
- male/female
- Basis for effect level:
- other: see "Remarks"
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Rats exposed subchronically to three different concentrations of Fe304 revealed findings clearly consistent with and typical for a 'poorly soluble particle'effect. Congruent with previous studies addressing the retention kinetics of inhaled Fe304 particles, neither analytical nor toxicological evidence existed that free, biosoluble iron was liberated from the inhaled dust to any appreciable extent. Also in this study no evidence of extrapulmonary toxicity existed. With regard to indicesconsidered to be adverse, viz. increased counts of cells and especially PMNs in BAL, elevated LDH as marker of cytotoxicity, and B-NAG as marker of increased lysosomal activities 4.7 mg/m3 constitute an exposure level without evidence ofadversity. These findings match those observed by histopathology. Thus, the results of this study support the view that the NOAEL (no-observed adverse effect level) of Fe304 is 4.7 mg/m3. As far as mild and borderline changes were observed they are considered to be associated with the exposure to PSPs rather than adversity. The effects found at higher exposure concentrations appear to be consistent of a particleoverload related inflammatory response. Comparison of findings of this study with published evidence from subchronic rat inhalation with titanium dioxide show that effects are clearly attributable to the particle per se rather than Fe304 or biosoluble iron.
Applicant's summary and conclusion
- Executive summary:
Protocol: Wistar rats (20 male and 20 female rats per group) were exposed in a subchronic 13-week inhalation study to three different concentrations of aerosolized Fe304 (Magnetite) dry powder (also abbreviated as Iron Oxide 'Black' throughout the report).
Exposure was 6-hours/day on five days/week for at least 13 consecutive weeks.
The rats were exposed to mean actual concentrations (i.e., breathing zone concentrations) of 4.7±0.6, 16.6±3.0, and 52.1 ±6.4 mg/m3, respectively. The control group was exposed under similar conditions to conditioned, dry air. The mode of exposure was dynamic directed-flow nose-only. Throughout the groups, the solid aerosol was highly respirable to rats, i.e., the mean mass median aerodynamic diameter (MMAD) was 1.3 µm, the geometric standard deviation (GSD) was ~2. Result: In summary, rats exposed subchronically to three different concentrations of Fe304 revealed findings clearly consistent with and typical for a 'poorly soluble particle'effect. Congruent with previous studies addressing the retention kinetics of inhaled Fe304 particles, neither analytical nor toxicological evidence existed that free, biosoluble iron was liberated from the inhaled dust to any appreciable extent. Also in this study no evidence of extrapulmonary toxicity existed. With regard to indices considered to be adverse, viz. increased counts of cells and especially PMNs in BAL, elevated LDH as marker of cytotoxicity, and B-NAG as marker of increased lysosomal activities 4.7 mg/m3 constitute an exposure level without evidence of adversity. These findings match those observed by histopathology. Thus, the results of this study support the view that the NOAEL (no-observed adverse effect level) of Fe304 is 4.7 mg/m3. As far as mild and borderline changes were observed they are considered to be associated with the exposure to PSPs rather than adversity. The effects found at higher exposure concentrations appear to be consistent of a particle overload related inflammatory response. Comparison of findings of this study with published evidence from subchronic rat inhalation with titanium dioxide show thateffects are clearly attributable to the particle per se rather than Fe304 or biosoluble iron.
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