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Diss Factsheets
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EC number: 944-188-0 | 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study - very well documented, study was performed with Fe3O4 as a representative for the iron oxide group - see Category approach for Fe2O3, Fe3O4, FeOOH, (Fe,Mn)2O3, (Fe,Mn)3O4, ZnFe2O4
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 412 (Subacute Inhalation Toxicity: 28-Day Study)
- Principles of method if other than guideline:
- Wistar rats (30 male rats per group) were exposed in a subacute 4-week inhalation study to four different concentrations of aerosolized Magnetite powder (Ferroxide Slack 88P, abbreviated also as 'iron oxide black' throughout the report).
Exposure was 6-hours/day on five days/week for four consecutive weeks. The rats were exposed to mean actual concentrations (i.e., breathing zone concentrations) of 10.1±1.4, 19.7±3.3, 45.6±6.8, and 95.8±17.6 mg/m3 air, 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 1.5 µm, the geometric standard deviation (GSD) was ~2.
During a 6 month postexposure period subgroups of rats (ten per sacrifice) were serially sacrificed 1, 8, and 24 weeks after the 4 week exposure period. - 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:
- Triiron tetraoxide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: unchanged (no vehicle)
- Remarks on MMAD:
- MMAD / GSD: MMAD = 1.5 µm; GSD ~2
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- 6 hours/day 5 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
10.1, 19.7, 45.6, 95.8 mg/m³
Basis:
analytical conc.
- No. of animals per sex per dose:
- 30
- Control animals:
- yes
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Remarks:
- Toxicity
- Effect level:
- 10.1 mg/m³ air
- Based on:
- test mat. (dissolved fraction)
- Sex:
- male
- Basis for effect level:
- other: See remarks
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
The evaluation of the lungs of rats exposed to four different concentrations of magnetite revealed findings clearly consistent with a poor soluble particle effect after 4-weeks exposure period followed by a 6-month postexposure period. Conclusive evidence of bioavailable iron particles that were translocated to extrapulmonary organs to any appreciable extent was not observed. Extrapulmonary effects causally linked to the exposure of magnetite were not found at any exposure concentration and time point. At the end of the 6-month postexposure period, the findings causally linked to the exposure to iron oxide (e.g. broncho-alveolar hypercellularity, septal thickening) showed a decrease in incidence and/or severity and occured essentially only at 95.8 mg/m³, a concentration shown to be high enough to cause a self-sustained type of inflammation due to a substantially delayed clearance of particles (t1/2 = 165 days) as a result of lung overload. Thus, the results of this study support the view that the NOAEL of magnetite is 10.1 mg/m³ with borderline effects at 19.7 mg/m³, a concentration considered to be at the transition of lung overloading.
Applicant's summary and conclusion
- Conclusions:
- NOAEL (no-observed adverse effect level) of Magnetite is 10.1 mg/m³ with borderline effects at 19.7 mg/m³.
- Executive summary:
- The evaluation of the lungs of rats exposed to four different concentrations of magnetite revealed findings clearly consistent with a poor soluble particle effect after 4-weeks exposure period followed by a 6-month postexposure period. Conclusive evidence of bioavailable iron particles that were translocated to extrapulmonary organs to any appreciable extent was not observed. Extrapulmonary effects causally linked to the exposure of magnetite were not found at any exposure concentration and time point. Thus, the results of this study support the view that the NOAEL of magnetite is 10.1 mg/m³ with borderline effects at 19.7 mg/m³, a concentration considered to be at the transition of lung overloading.
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