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EC number: 215-168-2 | CAS number: 1309-37-1
- 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
Acute toxicity, oral: LD50 > 5000mg/kg bw
Acute toxicity, inhalation: LC50 > 5,05mg/L
Acute toxicity, dermal: Conduct of an acute dermal toxicity study is unjustified as inhalation of the substance is considered as major route of exposure and physicochemical properties and dermal absorption data of the substance do not suggest a significant rate of absorption through the skin (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006).
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: short report available
- Principles of method if other than guideline:
- Single oral application per gavage, post observation time: 14 days, test substance was applied in water
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 10000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Clinical signs:
- other:
- Executive summary:
Single oral application per gavage, post observation time: 14 days, test substance was applicated in water.
Result: no mortality, no signs of toxicity.
Reference
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 sufficient documented
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Principles of method if other than guideline:
- 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.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- other: snout only exposure
- Vehicle:
- air
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5.05 mg/l
- No. of animals per sex per dose:
- 5 male and 5 female rats
- Control animals:
- no
- Key result
- 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
Study Design
The study design comprised 5 male and 5 female animals to determine the tolerability to the maximum aerosol concentration of 5 mg/L. As all animals survived until scheduled termination, no further animal exposures were required and the study was completed.
The following investigations were performed: clinical observations, body weights and necropsy.
Results
Mortality
There were no premature deaths.
Clinical observations
During exposure, from 1h of exposure onwards, all animals had brown staining, recorded as around the head area from 1.5h until the end of exposure. Following exposure on the day, all animals had a rolling gait immediately on completion of exposure, which was no longer evident by 30 min post exposure. All animals were noted to have brown staining following exposure which persisted in all but 2 males until termination on Day 15. Rolling gait was considered to be unremarkable, and brown staining was considered to be test item deposition.
Body weight
A few animals showed a transient and slight body weight reduction post exposure, which is common in inhalation studies and considered to be procedural. All animals had gained body weight by the end of the 14 day post exposure observation period. There was no effect of CERAC-Pigment inhalation on body weight.
Necropsy findings
All findings were considered to be unremarkable. All males had no abnormalities detected, and 3 of 5 females had uterine dilatation with one of these having a scab on the tail. These findings were considered typical for rats of the age and strain used and unrelated to exposure. One female had dark red discolouration of the mandibular lymph node which was considered most likely to be deposition of test item, despite no histopathological evaluation of the tissue.
This finding was considered to be unremarkable in rats exposed to a high concentration of red powder for 4 h. A toxic response to exposure was not established.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 5 050 mg/m³ air
- Quality of whole database:
- GLP guideline study
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Clinical signs:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In 2 reliable acute toxicity studies (with nano- and powder material) 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.
In a further study an acute oral toxicity study of Fe2O3-30 (iron oxide nanomaterial) and Fe2O3 powder was conducted following Organization for Economic Cooperation and Development guidelines 420 (OECD, 2001); in brief, the sighting study was conducted with a single female rat with 5, 50, 300, and 2,000 mg/kg doses to understand the dose-toxicity relationship. Because no mortality was observed at any of the above-listed doses by both the compounds tested, a limit test was carried out at the 2,000 mg/kg dose with 5 female rats and observed for 14 days. None of the animals died.
In a GLP guideline study according OECD TG 403 the discriminating dose for acute inhalation toxicity 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
Two valid studies with iron(III)oxide as powder- and nanomaterial are available
Justification for selection of acute toxicity – inhalation endpoint
key study is used
Justification for classification or non-classification
In several acute oral toxicity studies a discriminating dose of 2000 mg/kg bw was determined. The discriminating dose for acute inhalation toxicity was 5050 mg/m³ in a GLP guideline study according OECD TG 403.
In a 2 week inhalation study with Fe2O3 a LD50 > 210 mg/m³ was found (6 h/d, 5 d/wk for 2 weeks. The repeated exposure at this concentration was not associated with any specific clinical signs, changes in body temperature or body weights. Due to the insolubility of Fe2O3 dermal absorption seems not to be a route of an appreciable incorporation of insoluble iron oxides. This fact is supported by the low oral toxicity and no evidence of systemic bioavailability of inhaled particles.
Therefore no classification is 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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