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EC number: 234-386-9 | CAS number: 11137-98-7
- 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
Adsorption / desorption
Administrative data
- Endpoint:
- adsorption / desorption: screening
- Type of information:
- other: expert statement
- Adequacy of study:
- key study
- Study period:
- January 2019
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Reference
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 July 2018 - 21 August 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- 1995
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7840 (Water Solubility)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- column elution method
- Key result
- Water solubility:
- 0.013 mg/L
- Conc. based on:
- test mat. (dissolved fraction)
- Remarks:
- based on Al analysis
- Temp.:
- 20 °C
- pH:
- >= 7.4 - <= 7.5
- Details on results:
- Mean concentration in the water samples (n=10) obtained at the flowrate of 24 mL/h was 0.014 mg/L. CV = 8.3%.
Mean concentration in the water samples (n=10) obtained at the flowrate of 12 mL/h was 0.011 mg/L. CV = 6.8%.
The maximum difference on the mean values at both flow rates was ≤ 30% (i.e. 25%). Average of two flow rates: 0.013 mg/L.
The coefficient of variation (CV) (n=10) was ≤ 30% at both flow rates. It demonstrated that the system was in equilibrium at all flow rates. - Conclusions:
- The water solubility of the substance at 20°C was determined to be approximately 0.013 mg/L.
- Executive summary:
The water solubility of the substance was determined using the column elution method in a GLP study according to EC A.6, OECD 105 and OPPTS 830.7840.
Quantification was performed by ICP-MS (based on Al). The water solubility of the substance at 20°C was determined to be approximately 0.013 mg/L (average of two flow rates - 24 mL/h and 12 mL/h, measured value is < LOQ of the method and obtained through extrapolation of the calibration curve).
The coefficient of variation (CV) (n=10) was ≤ 30% at both flow rates.
The maximum difference on the mean values at both flow rates was ≤ 30%.
The pH of the aqueous samples was 7.4 -7.5.
The turbidity of the eluates was < 0.2 NTU. According to this, no undissolved particles were detected in the eluates.
No test item was detected in the samples from the blank column.
Data source
Reference
- Reference Type:
- other: Expert statement
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The suitability/applicability of available test guidelines for adsorption/desorption was theoretically assessed in relation to the inorganic nature of the substance.
- GLP compliance:
- no
- Type of method:
- other: theoretical assessment of the suitability/applicability of available test guidelines (HPLC, QSAR and batch equilibrium)
Test material
- Reference substance name:
- Aluminum magnesium oxide
- EC Number:
- 234-386-9
- EC Name:
- Aluminum magnesium oxide
- Cas Number:
- 11137-98-7
- Molecular formula:
- Al2MgxO(3+x) where x = 4.3-4.6
- IUPAC Name:
- Aluminum magnesium oxide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: White powder
- Storage condition: At room temperature desiccated
Constituent 1
Results and discussion
Adsorption coefficientopen allclose all
- Key result
- Type:
- log Koc
- Remarks on result:
- not determinable
- Remarks:
- - HPLC screening method not applicable for inorganic substances
- Key result
- Type:
- log Koc
- Remarks on result:
- not determinable
- Remarks:
- - QSAR (based on log Pow) not applicable due to lack of Pow data (not possible/meaningful to determine for inorganic substances)
Any other information on results incl. tables
Column 2 of the REACH Annex VIII endpoint point 9.3.1. (Adsorption/desorption screening) provides 2 specific adaptation rules from the standard information requirements.
However, these adaptation rules cannot be applied to inorganic substances for the following reasons:
- the potential for adsorption based on e.g. a low octanol water partition coefficient cannot be assessed for inorganic substances because the octanol water partition coefficient of inorganic substances can usually not be determined (e.g. due to solubility issues).
- rapid decomposition of degradation products is not applicable because inorganic substances do not degrade in a similar fashion as organic substances.
Proposed screening methods, such as the HPLC estimation method or QSAR, are not deemed applicable due to the inorganic nature of the substance, its poor solubility in water and commonly used solvents in the HPLC screening test as well as expected detection issues. In addition, the HPLC estimation method is not validated for inorganic substances, as pointed out in the test guidelines (OECD 121 and EU C.19). Furthermore, no valid QSAR models are available for inorganic substances to predict physico-chemical properties, so it is not possible to provide e.g. a calculated log Pow value (nor details of the calculation method, or details on the applicability domain of the model), and thus calculation of log Koc (based on log Pow) is also not possible.
Finally, the applicability of performing a batch equilibrium method was assessed. Considering that, due to the inorganic nature of the substance in combination with its poor solubility in water, most of the parameters required as a pre-requisite for performing an OECD 106 test (abiotic degradation, log Pow, ready biodegradability, pKa and direct photolysis in water) cannot be acquired, and taking into account that analytical monitoring of the substance as such (or dissolved ions) in test solutions at very low concentrations is not expected to be accurate and reliable, due to sensitivity issues, it was concluded that a batch equilibrium test very likely cannot be performed either.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- not applicable
- Conclusions:
- Based on available physico-chemical information and in view of the inorganic nature of the substance it is concluded that it is considered scientifically justified to waive testing for adsorption/desorption of this inorganic substance.
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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