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EC number: 257-098-5 | CAS number: 51274-00-1 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77492.
- 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
In an oral acute toxicity study 10 animals were treated with 10000 mg/kg bw FeOOH. During an observation time of 14 days none of the animals showed signs of toxicity or died. In an 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.
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: scientifically acceptable and sufficient documented
- Principles of method if other than guideline:
- Single oral application by means of gavage
- GLP compliance:
- not specified
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 10 g/kg
- No. of animals per sex per dose:
- 10
- Control animals:
- not specified
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Clinical signs:
- other:
- Executive summary:
- 10 animals were treated with 10000 mg/kg bw of the test substance. During an observation time of 14 days none of the animals showed signs of toxicity or died.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 10 000 mg/kg bw
- Quality of whole database:
- scientifically acceptable and sufficient documented
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of 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: as reported in source record
- Justification for type of information:
- see attachment "Endpoint-specific read-across justification for the iron oxide category" in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Duration of exposure:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- discriminating conc.
- Effect level:
- 5.05 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Executive summary:
Five male and 5 female Wistar rats were exposed single to 5 mg/l CERAC-Pigment (average particle size = 35 nm) for 4 hours. The animals were observed for mortality, clinical signs and body weight during a post-observation period of 14 days. A pathological examination was performed on all animals which died during the observation period or were sacrificed at the end of the study period.
Following a single snout only inhalation exposures to CERAC-Pigment for four hours at an aerosol concentration of 5 mg/L, all animals tolerated the exposure. The Median Lethal Concentration (MLC) was therefore considered to be in excess of 5 mg/L.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 5 050 mg/m³ air
- Quality of whole database:
- GLP gudieline study
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- other justification
- Justification for data waiving:
- the study does not need to be conducted because inhalation of the substance is likely
- the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
- Clinical signs:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a reliable acute toxicity study rats received per gavage doses of 10000 mg/kg bw of the test substance. Neither symptoms nor mortality were observed. Therefore the discriminating dose is > 10000 mg/kg bw.
No study for acute dermal toxicity is available. In a 2 week inhalation toxicity study (6 hours/day on 5 days/week) in rats 195 mg/m³ FeOOH (nanomaterial) caused no death in the test animals. Therefore based on this study the discriminating dose for FeOOH is > 195 mg/m³/6 h. 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 physicochemical properties (insoluble in water and organic solvents) no systemic bioavailability is expected by the dermal route.
Justification for selection of acute toxicity – oral endpoint
Key study is used
Justification for selection of acute toxicity – inhalation endpoint
key study is used
Justification for classification or non-classification
In an oral acute toxicity study 10 animals were treated with 10000 mg/kg bw FeOOH. During an observation time of 14 days none of the animals showed signs of toxicity or died. In an 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 physicochemical properties (insoluble in water and organic solvents) no systemic bioavailability is expected.
A classification is not required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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