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EC number: 266-007-8 | CAS number: 65996-74-9 The oxidized surface of steel produced during reheating, conditioning, hot rolling, and hot forming operations. This substance is usually removed by process waters used for descaling, roll and material cooling, and other purposes. It is subsequently recovered by gravity separation techniques. Composed primarily of high-purity iron oxides. May contain varying amounts of other oxides, elements, and trace compounds.
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Mill scale is mainly and primarily composed of high-purity iron oxides (on average above 65%, i.e. FeO, Fe2O3, Fe3O4). Besides, other metal oxides and spinels, elements, and trace compounds such as oil residues <1% for all the uses except for batteries and Melting charge for which <3% can be found in the mill scale. More information on the justification of read across can be found in the attached document in the endpoint summarie of section 7.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.3465 (90-Day Inhalation Toxicity)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: EC Directive 67/302/EEC
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Iron(II,III) oxide
- IUPAC Name:
- Iron(II,III) oxide
- 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(II) diiron(III) oxide
- Reference substance name:
- triion tetraoxide
- IUPAC Name:
- triion tetraoxide
- Details on test material:
- - Name of test material (as cited in study report): iron oxide 'black' or magnetite (ferroxide black 88P; purchased by ROCKWOOD ITALIA)
- Molecular formula (if other than submission substance): Fe3O4
- Physical state: solid; powder
- Analytical purity/impurities:
PURITY DATA
mg/kg Batch Specification
Arsenic (As) <1 Max. 3
Barium (Ba) 6 Max. 50
Cadmium (Cd) <1 Max. 5
Chromium (Cr) 36 Max. 100
Mercury (Hg) <0.1 Max. 1
Nickel (Ni) 42 Max. 50
Lead (Pb) <3 Max. 10
Copper (Cu) 11 Max. 50
Zinc (Zn) 75 Max. 100
Fe content (%) 69.5 Min. 68
- Purity test date: 25/02/2004
- Lot/batch No.: 846
- Storage condition of test material: room temperature
- Other
specific surface area: 10.5 m2/g (BET, DIN 66131, 90% He, 10% N2)
EINECS: 215-277-5
Appearance: powder with characterisitic colour
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Remarks:
- dynamic air-flow
- Vehicle:
- air
- Remarks:
- conditioned dry air
- Remarks on MMAD:
- MMAD / GSD: 1.3 µm/ ~ 2
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 6h per day; 5 days/week; 10 animals/group/sex were exposed for 13 consecutive weeks; 10 animal/group/ sex were exposed for 14-15 consecutive weeks
- Frequency of treatment:
- 5 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0 (conditioned dry air), 4.7 ±0.6, 16.6 ±3 and 52.1 ±6.4 mg/m3 (target concentrations: 5, 15 and 50 mg/m3)
Basis:
analytical conc.
- No. of animals per sex per dose:
- 20
- Control animals:
- yes, concurrent vehicle
Results and discussion
Effect levels
- Dose descriptor:
- NOAEC
- Effect level:
- 4.7 mg/m³ air (analytical)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: adverse effects observed in BAL fluid (PMNs, protein levels) and relative lung weights
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1: Summary of subchronic inhalation toxicity of Fe3O4dry powder.
N Group/sex |
Target concentration (mg/m3) |
Toxicological result |
Onset and duration of signs |
Onset and duration of mortality |
1/m |
0 |
0/0/20 |
- |
- |
2/m |
5 |
0/0/20 |
- |
- |
3/m |
15 |
0/0/20 |
- |
- |
4/m |
50 |
0/0/20 |
- |
- |
1/f |
0 |
0/0/20 |
- |
- |
2/f |
5 |
0/0/20 |
- |
- |
3/f |
15 |
0/0/20 |
- |
- |
4/f |
50 |
0/0/20 |
- |
- |
N= group assignment, m=males, f= females.Values given in the ‘Toxicological Results’ column are:1st= No of deaths,2nd= No of animals with signs after cessation of exposure and3rd= No of animals exposed.
The table below presents the findings from clinical sings and observations. No mortality was found. The clinical results did not occur in any consistent concentration or time-related manner.
Table 2: Signs and observations.
Group 1/m |
Palpable mass flank, eschar formation skin |
Group 2/m |
Nose: red encrustations |
Group 3/m |
No findings |
Group 4/m |
Nose: red encrustations |
Group 1/f |
Nose: red encrustations |
Group 2/f |
No findings |
Group 3/f |
No findings |
Group 4/f |
Nose: red encrustations, discharge from eyes, eyelids reddened, alopecia, eyelids swollen |
Applicant's summary and conclusion
- Conclusions:
- These results were clearly consistent with what would be expected for a poorly soluble particle, indicating their clearance in the lungs, via efficient phagocytosis by the alveolar macrophages and/or movement into the lymphatic system.
- Executive summary:
In a subchronic inhalation toxicity study Fe3O4 aerosols were administered to Wistar rats(20 male and 20 female per group)by the dynamic directed-flow nose-only thechnique; actual mean concentrations were 0, 4.7 ±0.6, 16.6 ±3 and 52.1 ±6.4 mg/m3 air; the animals were exposed for 6 h/day, 5 days/week over a period of 13 weeks.Ten rats/group were necropsied 1 -2 weeks later (exposure continued). Particles hada MMAD of 1.3 µm and GSD ~2. The exposure was not associated with any specific clinical signs and consistent changes in body weights. Hematology, clinical pathology and urinanalysis were unobtrusive. TheNOAEC was 4.7 mg/m3, based on the findings from BAL analysis and histopathology. Mild and borderline changes were considered to be associated with the exposure to poorly soluble particles rather than specific toxicity of the tested particles. The effects found at higher concentrations appear to be consistent with a particle-overload related inflammatory response.
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