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EC number: 701-090-0 | 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

Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 6.5 µg/L
- Assessment factor:
- 3
- Extrapolation method:
- sensitivity distribution
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 3.4 µg/L
- Assessment factor:
- 3
- Extrapolation method:
- sensitivity distribution
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 100 µg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 174 mg/kg sediment dw
- Assessment factor:
- 3
- Extrapolation method:
- sensitivity distribution
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 164 mg/kg sediment dw
- Assessment factor:
- 3
- Extrapolation method:
- sensitivity distribution
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- PNEC soil
- PNEC value:
- 147 mg/kg soil dw
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- PNEC oral
- PNEC value:
- 10.9 mg/kg food
- Assessment factor:
- 6
Additional information
The substance is a multi-constituent substance and no ecotoxicological data is available for the substance itself. Data is presented for one of the major constituents, hematite (Fe2O3), and for the lead impurity.
Iron is an essential trace element, well regulated in all living organisms. The available evidence shows the absence of iron biomagnification across the trophic chain both in the aquatic and terrestrial food chains. The existing information suggests not only that iron does not biomagnify, but rather that it tends to exhibit biodilution. Therefore the need for additional testing for secondary poisoning can be waived.
For the lead impurity:
In assessing the ecotoxicity of metals in the various environmental compartments (aquatic, terrestrial and sediment), it is assumed that toxicity is not controlled by the total concentration of a metal, but by the bioavailable form. For metals, this bioavailable form is generally accepted to be the free metal-ion in solution. In the absence of speciation data and as a conservative approximation, it can also be assumed that the total soluble lead pool is bioavailable. All reliable data on ecotoxicity and environmental fate and behaviour of lead and lead substances were therefore selected based on soluble Pb salts or measured (dissolved) Pb concentration.
The reliable ecotoxicity data selected for effects assessment of Pb in the various environmental compartments are derived from tests with soluble Pb salts (lead (di)nitrate, lead carbonate, lead acetate, lead chloride). Since lead is the toxic component and the anions do not contribute to toxicity, all reliable data are grouped together in a read-across approach and the PNEC’s are expressed as μg Pb/L (measured dissolved concentration) or mg Pb/kg. These results can be used for all other Pb compounds without concern on toxicity of the anions.
Conclusion on classification
The substance is a multi-constituent substance and no ecotoxicological data is available for the substance itself. Data is presented for one of the major constituents, hematite (Fe2O3), and for the lead impurity.
Iron is an essential trace element, well regulated in all living organisms. The available evidence shows the absence of iron biomagnification across the trophic chain both in the aquatic and terrestrial food chains. The existing information suggests not only that iron does not biomagnify, but rather that it tends to exhibit biodilution. Therefore the need for additional testing for secondary poisoning can be waived.
For LEAD:
A precautionary read across approach based on water solubility data derived from OECD 105 water solubility testing, was used to determine the environmental hazard classification. In absence of full TDp data on this compound a temporally reasonable worst case environmental classifications was derived from the water solubility test results :
· Under DSD : R50/53, with an M factor of 1 (The R53 is automatically applied by default given the failure of the TDp screening test read across)
· Under CLP : Acute 1-Chronic 1, with an M factor of 1
This environmental classification recommendation holds all mixtures in which the compound is used if each of the mixture contains at least 25 % of the composing material.
In line with annex 4 chapter IV.5.3 of the CLP, Metal compounds must be classified by comparing Transformation Dissolution data with toxicity date for the soluble metal ion. The availability of toxicity information on the soluble ion (developed under the Lead metal registration file) makes the requirement for aquatic ecotoxicity tests redundant.
Transformation Dissolution data in accordance to the OECD protocol are not available for this compound, but water solubility data (saturation levels at relevant time intervals for the environmental classification) is available. There is no further need for developing Transformation Dissolution data given a reasonable worst case read across approach comparing the water solubility data from the OECD 105 test with the acute toxicity reference values demonstrates that the compound is sufficiently soluble to warrant a classification as R50-53 or Acute 1-Chronic 1. Further additional Transformation dissolution testing would in general not be capable to improve this situation justifying the requested waiving for TDp data.
Based on the available data, the iron oxides of this category are not harmful to aquatic organisms.A precautionary read across approach based on water solubility data derived from OECD 105 water solubility testing, was used to determine the environmental hazard classification. In absence of full TDp data on this compound a temporally reasonable worst case environmental classifications was derived from the water solubility test results :
· Under DSD : R50/53, with an M factor of 1 (The R53 is automatically applied by default given the failure of the TDp screening test read across)
· Under CLP : Acute 1-Chronic 1, with an M factor of 1
This environmental classification recommendation holds all mixtures in which the compound is used if each of the mixture contains at least 25 % of the composing material.
In line with annex 4 chapter IV.5.3 of the CLP, Metal compounds must be classified by comparing Transformation Dissolution data with toxicity date for the soluble metal ion. The availability of toxicity information on the soluble ion (developed under the Lead metal registration file) makes the requirement for aquatic ecotoxicity tests redundant.
Transformation Dissolution data in accordance to the OECD protocol are not available for this compound, but water solubility data (saturation levels at relevant time intervals for the environmental classification) is available. There is no further need for developing Transformation Dissolution data given a reasonable worst case read across approach comparing the water solubility data from the OECD 105 test with the acute toxicity reference values demonstrates that the compound is sufficiently soluble to warrant a classification as R50-53 or Acute 1-Chronic 1. Further additional Transformation dissolution testing would in general not be capable to improve this situation justifying the requested waiving for TDp data.
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