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Diss Factsheets
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EC number: 215-721-8 | CAS number: 1345-25-1
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Starting point
In consideration of the available data no acute or chronic oral or dermal effects of the members of the category are expected. From mutagenicity studies (Bayer, 1982e; Moriya et al., 1983; Bevan and Manger, 1985; Fujita et al., 1994; Bayer 1990, Bayer 2008 a, b, c) and despite the widespread use and ubiquitous occurrence of the category members no carcinogenic potential of the group members is identified (Steinhoff, Mohr, and Hahnemann, 1991).
The only critical exposure pathway to humans is the inhalation of the dust of the compounds of the group members. Therefore it is only necessary to consider this way of exposure as a threshold mode of action for workers and the general population.
Due to the same physicochemical properties and the absence of systemic effects of iron oxides, Fe3O4 has been chosen as a representative substance and the results of the inhalations studies are significant for Fe2O3 and FeO as for the iron oxides.
For Fe3O4 valid subacute and subchronic inhalation studies (according OECD) are available (Bayer, 2006a; Bayer, 2006b).
The NOAECs are 10.1 mg/m³ from the 28 days study (Bayer, 2006b) and 4.7 mg/m³ from the 90 days study ( Bayer, 2006a) with LOAECs of 19.7 mg/m³and 16.6 mg/m³, respectively. In the subchronic inhalation study in rats exposure was 6 hours/day, 5 days/week for 13 weeks.
In the 13 weeks study the rats were exposed to mean actual concentrations (i.e. breathing zone volumes) of highly respirable aerosol of 4.7 +/- 0.6, 16.6 +/- 3.0 and 52.1 +/- 6.4 mg/m³, respectively. The repeated exposure was not associated with any specific clinical signs. Hematology, clinical pathology and urinalysis were unobtrusive. No evidence of extrapulmonary toxicity existed (Bayer, 2006a).
With regard to the most sensitive parameters considered to be adverse, viz. increased counts of cells and especially PMNs in BAL, elevated LDH as marker of cytotoxicity, and ß-NAG as marker of increased lysosomal activities 4.7 mg/m³ constitute an exposure level without evidence of adversity (Bayer, 2006a).
The NOAEC of Fe3O4 as a surrogate for the whole group is 4.7 mg/m³ for respirable dust. Non-specific toxicity consistent with a ‘poorly soluble particle’ and no specific toxicity were observed at higher concentrations at the port of entry (respiratory tract) only (Bayer, 2006a). There is no evidence of systemic toxicity, genotoxicity or carcinogenicity. Therefore the group can be treated as dust without specific toxicity and the general dust limit applies.
Derivation of DNEL:
According to ECHA Guidance Document R.8; Appendix R 8-13 a national Occupational Exposure Limit (OEL) can be used in place of a DNEL under certain circumstances. For general dust in Germany the current binding national Occupational Exposure Limit is 10 mg/m3 for inhalable and 3 mg/m3 for respirable dust (TRGS900; http://www.baua.de/cae/servlet/contentblob/666764/publicationFile/55580/TRGS-900.doc), whereas the German MAK commission has published a value of 4 mg/m3 for inhalable and 1.5 mg/m3 for respirable dust (DFG, 2009).
The use of the official national German value for general dust is in line with the proposal in ECHA Guidance document R8 from May 2008. Here it is stated that the general dust limits of 10 mg/m3 for the inhalable airborne fraction and 3 mg/m3 for the respirable airborne fraction used in setting Occupational Exposure Limits in many countries should be considered in combination with nature of the dust. It is stated in the ECHA Guidance document that for non-soluble inert dusts if the derived DNEL for inhalation is above these dust limits, the general dust limits should apply for exposure scenarios with exposure to dust (see chapter 8.7.1, page 54 of ECHA guidance document R.8 from May 2008).
In the case of the ferrous oxides covered by this assessment based on the data of the 13-week inhalation toxicity study it was demonstrated that the effects after inhalation are attributable to the particle per se rather than a substance specific toxicity; therefore the use of the general dust limit value as DNEL is confirmed by experimental data. The NOAEC for repeated inhalation in the 13 week study for the respirable dust is higher than the respective general dust limit and therefore does not argue against that approach.
Overall, based on
• the substance-specific data on the mode of action of iron oxide after inhalation,
• the available 90 day inhalation toxicity study and
• the ECHA guidance how to select the critical DNEL in case of inert dusts
the current binding national Occupational Exposure Limit in Germany for dust of 10 mg/m3 for inhalable and 3 mg/m3 for respirable dust (TRGS900) will be used as DNEL for long term exposure to iron oxides.
Iron(II)Oxide belongs to the iron oxides family and presents comparable physico chemical properties, leading to similar behaviour for the all members of the iron oxide substances. In particular, based on affinity of the chemical structure, Iron Oxide (Fe3O4) and Iron(III)Oxide (Fe2O3) are selected to support read across for the Iron(II)Oxide dossier. Full justification paper is attached in the current Summary Section.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The only critical exposure pathway to humans is the inhalation of the dust of the compounds of the group members. Therefore it is only necessary to consider this way of exposure as a threshold mode of action for workers and the general population. However, consumers are not exposed via inhalation as the substance is bound physically in the matrix of an article. Therefore, no relevant exposure via inhalation is expected for consumers.
Iron(II)Oxide belongs to the iron oxides family and presents comparable physico chemical properties, leading to similar behaviour for the all members of the iron oxide substances. In particular, based on affinity of the chemical structure, Iron Oxide (Fe3O4) and Iron(III)Oxide (Fe2O3) are selected to support read across for the Iron(II)Oxide dossier. Full justification paper is attached in the current Summary Section.
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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