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Diss Factsheets
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EC number: - | 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
Endpoint summary
Administrative data
Description of key information
No studies conducted with target substance on irritation/corrosion are available.
According to the results of specific bioelution testing with the test substance (Klawonn, 2021, please see IUCLID section 7.1.1), aluminium has the highest relative release into artificial physiological media representing relevant exposure routes and therefore was considered as main constituent for the human health hazard/risk assessment of the substance "Neutralisation and reduction products of bauxite residue from refinement process.
Aluminium ions show very low release in the Artificial sweat solution (33.2 µg/g of Alferrock/liter within 2h and 150.3 µg/g of substance/liter after 24 hours, see IUCLID section 7.1.1). Considering the limited elution of Al into such artificial physiological media as artificial sweat solutions and phosphate buffered saline it could be assumed that Al remains bound in the particles and could not cause such local effects as irritation or corrosion. Therefore, it can be assumed that no local effects would be expected at such a low concentration of bioaccessible aluminium released from of the substance.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no study available
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
For human health endpoints, the relative bioavailability of different metal-ions from the substance "Neutralisation and reduction products of bauxite residue from refinement process" would determine its potential to cause toxicological effects and also govern the severity of such effects. The dissolution rate of the substance in artificial physiological fluids, including Artificial gastric fluid (pH = 1.5), Phosphate buffered saline (pH = 7.4), Gamble´s solution (pH = 7.4), Artificial lysosomal fluid (pH = 4.5) and Artificial sweat solution (pH = 6.5) was investigated by Klawonn et al. (2021b, see IUCLID section 7.1.1). Based on this approach, release rates of metal ions at the sites of first contact for the human-relevant exposure routes can be simulated.
According to the results of the bioelution testing, aluminium has the highest relative release into artificial physiological media and therefore was considered as main constituent for the human health hazard/risk assessment of the substance. Release of aluminium into Artificial sweat solution (pH = 6.5) simulates an exposure scenario in contact with human skin. Aluminium ions show very low release in the Artificial sweat solution (33.2 µg/g of test item/liter within 2h and 150.3 µg/g of test item/liter after 24 hours, see IUCLID section 7.1.1). Similarly, PBS (pH 7.4) can be regarded as a surrogate for the conditions upon ocular contact. Aluminium ions show very low release in PBS at rates of 11.6 µg/g test item and 71.5 µg/g test item after 2h and 24 h, respectively. Aluminium can therefore be considered practically insoluble under conditions of dermal and ocular exposure.
Considering this very limited elution of aluminium into artificial sweat and PBS solutions it could be assumed that aluminium remains bound in the matrix of "Neutralisation and reduction products of bauxite residue from refinement process" and would not be locally accessible to penetrate the skin barrier or cause local effects, such as irritation or corrosion. Therefore, it can be assumed that no local effects would be expected at such a low concentration of bioaccessible aluminium upon skin and eye contact with the substance. Conducting a study on skin irritation/corrosion and eye damage/irritation is therefore considered to be scientifically unjustified.
Justification for classification or non-classification
According to the results of the bioelution testing (see IUCLID section 7.1.1), aluminium has the highest relative release into artificial physiological media and therefore was considered as main constituent for the human health hazard/risk assessment of "Neutralisation and reduction products of bauxite residue from refinement process". For details and justification of read-across please refer to the report attached in section 13 of IUCLID.
Considering the limited elution of Al into such artificial physiological fluids as Artificial sweat solutions and Phosphate buffered saline, it could be assumed that aluminium remains bound in the particles and could not cause such local effects as irritation or corrosion. Therefore, classifications for skin irritation/corrosion or eye irritation according to the criteria of Annex I of Regulation (EC) 1272/2008 (CLP Regulation) are not warranted.
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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