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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
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- theoretical assessment
- Type of information:
- other: theoretical assessment based on physchem properties and all data available
- Adequacy of study:
- key study
- Study period:
- February 2019
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Theoretical assessment taking all currently available relevant information into account, based on the REACH Guidance: Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7c Endpoint specific guidance.
- GLP compliance:
- no
- Type:
- absorption
- Results:
- Based on the physical/chemical properties of the substance, absorption factors for this substance are derived to be 10% (oral), 10% (inhalation) and 10% (dermal) for risk assessment purposes.
- Conclusions:
- A toxicokinetic assessment was performed based on the available data of the substance Aluminium magnesium oxide. Based on the physical/chemical properties of the substance, absorption factors for this substance are derived to be 10% (oral), 10% (inhalation) and 10% (dermal) for risk assessment purposes. The bioaccumulation potential is expected to be low.
Reference
A chemical substance can enter the body via the gastrointestinal tract, the lungs and the skin. In general, a compound needs to be dissolved before it can be taken up from the gastrointestinal tract after oral administration. [1]
Aluminium magnesium oxide is an inorganic substance with a very low water solubility (approximately 0.013 mg/L at 20°C). As the substance is an inorganic substance, there is no information on the partition coefficient. The very low water solubility is indicative for low systemic uptake as Aluminium magnesium oxide will only dissolve to a limited extent into the gastrointestinal fluid. The moderate molecular weight (≥275.3 g/mol, ≤287.4) is not considered to have a significant influence on systemic uptake of Aluminium magnesium oxide.
No data are available on the dissociation constant of Aluminium magnesium oxide, therefore it is unclear in which state (ionized or not ionized) the substance will be present under physiological circumstances in the stomach or intestinal tracts. Since it is generally thought that ionized substances do not readily diffuse across biological membranes, the state of the substance might hamper uptake. Although Aluminium magnesium oxide is expected to dissociate in the low pH environment of the stomach into Mg2+and Al3+, the presence of these ions in the intestine, where further systemic uptake occurs, is considered to be low, as the intestinal pH is significantly higher than in the stomach.
Considering all this data, there are indications that oral absorption of Aluminium magnesium oxide is largely hampered: being an inorganic substance with moderate molecular size, and the very limited ability to dissolve in water do not favour systemic uptake. Therefore, for risk assessment purposes oral absorption of Aluminium magnesium oxide of 10% can be considered as worst case assumption. [2] The oral toxicity data do not provide reason to deviate from the proposed oral absorption factor.
As the substance is a solid which melts above 300 C, determination of the vapour pressure of the substance is not feasible as it is considered to be very low. Therefore that the amount of Aluminium magnesium oxide that will reach the nasopharyncheal region or subsequently the tracheo/bronchial/pulmonary region via inhalation of vapour is considered to be negligible.
Aluminium magnesium oxide is a powder, with a mean particle size of around 25.61 µm; 88.6% of the particles have a particle size below 100 μm, 84.7% below 50 μm and about 50% of the particles are smaller than 15 μm. In humans, particles with aerodynamic diameters below 100 μm have the potential to be inhaled. Particles with aerodynamic diameters below 50 μm may reach the thoracic region and those below 15 μm can reach the alveolar region of the respiratory tract. Based on the size of the particles, 84.7% below 50 μm is therefore expected to be able to reach all parts of the lung upon inhalation. If the substance reaches these regions, Aluminium magnesium oxide is not likely to dissolve in the mucus lining the respiratory tract due to the very limited water solubility, and therefore absorption is considered to be limited. Also uptake through respiratory epithelium will be limited for Aluminium magnesium oxide due to the very limited water solubility.Aluminium magnesium oxide deposited in the tracheobronchial region is expected to be cleared from the lungs by the mucocilliary mechanism and might be swallowed. However, a small amount (particles around 1μm) may be taken up by phagocytosis and transported to the blood via the lymphatic system.Therefore, for risk assessment purposes the inhalation absorption of Aluminium magnesium oxide is set at 10%. [2]
Aluminium magnesium oxide is a powder and its water solubility is very limited. Therefore the ability to dissolve into the surface moisture of the skin to allow uptake and partitioning from the stratum corneum into the epidermis is considered restricted. According to the guidance on dermal absorption [2], a default value of 100% skin absorption is generally used unless molecular weight is above 500 and log Pow is outside the range [-1, 4]. Since the substance is inorganic with a very low water solubility and no log Pow value, it does not meet either criteria. However, it is generally accepted that dermal absorption is not higher than oral absorption. Therefore, the dermal absorption of Aluminium magnesium oxide is considered to be 10% for risk assessment purposes, equal to oral absorption. [2]
Once absorbed, distribution of the test substance throughout the body is not expected based on its very low water solubility. After uptake, it is not expected that Aluminium magnesium oxide is metabolized, as it is an inorganic substance. Excretion will take place via urine and faeces. [3] Bioaccumulation is expected to be limited.
References:
Ref. 1 Martinez MN, Amidon GL. Mechanistic approach to understanding the factors affecting drug absorption: a review of fundamentals. J Clin Pharmacol 2002; 42: 620-43.
Ref. 2 Guidance for the implementation of REACH. Guidance on information requirements and chemical safety assessment. Chapter R.7c: Endpoint specific guidance. European Chemical Agency, Version 6.0 November 2016.
Ref. 3 Parkinson A. In: Casarett and Doull’s Toxicology, The basic science of poisons. Sixth edition. Ed. C.D. Klaassen. Chapter 6: Biotransformation of xenobiotics. McGraw-Hill, New York, 2001.
Description of key information
A toxicokinetic assessment was performed based on the available data of the substance Aluminium magnesium oxide. Based on the physical/chemical properties of the substance, absorption factors for this substance are derived to be 10% (oral), 10% (inhalation) and 10% (dermal) for risk assessment purposes. The bioaccumulation potential is expected to be low.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 10
- Absorption rate - dermal (%):
- 10
- Absorption rate - inhalation (%):
- 10
Additional information
A chemical substance can enter the body via the gastrointestinal tract, the lungs and the skin. In general, a compound needs to be dissolved before it can be taken up from the gastrointestinal tract after oral administration. [1]
Aluminium magnesium oxide is an inorganic substance with a very low water solubility (approximately 0.013 mg/L at 20°C). As the substance is an inorganic substance, there is no information on the partition coefficient. The very low water solubility is indicative for low systemic uptake as Aluminium magnesium oxide will only dissolve to a limited extent into the gastrointestinal fluid. The moderate molecular weight (≥275.3 g/mol, ≤287.4) is not considered to have a significant influence on systemic uptake of Aluminium magnesium oxide.
No data are available on the dissociation constant of Aluminium magnesium oxide, therefore it is unclear in which state (ionized or not ionized) the substance will be present under physiological circumstances in the stomach or intestinal tracts. Since it is generally thought that ionized substances do not readily diffuse across biological membranes, the state of the substance might hamper uptake. Although Aluminium magnesium oxide is expected to dissociate in the low pH environment of the stomach into Mg2+and Al3+, the presence of these ions in the intestine, where further systemic uptake occurs, is considered to be low, as the intestinal pH is significantly higher than in the stomach.
Considering all this data, there are indications that oral absorption of Aluminium magnesium oxide is largely hampered: being an inorganic substance with moderate molecular size, and the very limited ability to dissolve in water do not favour systemic uptake. Therefore, for risk assessment purposes oral absorption of Aluminium magnesium oxide of 10% can be considered as worst case assumption. [2] The oral toxicity data do not provide reason to deviate from the proposed oral absorption factor.
As the substance is a solid which melts above 300 C, determination of the vapour pressure of the substance is not feasible as it is considered to be very low. Therefore that the amount of Aluminium magnesium oxide that will reach the nasopharyncheal region or subsequently the tracheo/bronchial/pulmonary region via inhalation of vapour is considered to be negligible.
Aluminium magnesium oxide is a powder, with a mean particle size of around 25.61 µm; 88.6% of the particles have a particle size below 100 μm, 84.7% below 50 μm and about 50% of the particles are smaller than 15 μm. In humans, particles with aerodynamic diameters below 100 μm have the potential to be inhaled. Particles with aerodynamic diameters below 50 μm may reach the thoracic region and those below 15 μm can reach the alveolar region of the respiratory tract. Based on the size of the particles, 84.7% below 50 μm is therefore expected to be able to reach all parts of the lung upon inhalation. If the substance reaches these regions, Aluminium magnesium oxide is not likely to dissolve in the mucus lining the respiratory tract due to the very limited water solubility, and therefore absorption is considered to be limited. Also uptake through respiratory epithelium will be limited for Aluminium magnesium oxide due to the very limited water solubility.Aluminium magnesium oxide deposited in the tracheobronchial region is expected to be cleared from the lungs by the mucocilliary mechanism and might be swallowed. However, a small amount (particles around 1μm) may be taken up by phagocytosis and transported to the blood via the lymphatic system.Therefore, for risk assessment purposes the inhalation absorption of Aluminium magnesium oxide is set at 10%. [2]
Aluminium magnesium oxide is a powder and its water solubility is very limited. Therefore the ability to dissolve into the surface moisture of the skin to allow uptake and partitioning from the stratum corneum into the epidermis is considered restricted. According to the guidance on dermal absorption [2], a default value of 100% skin absorption is generally used unless molecular weight is above 500 and log Pow is outside the range [-1, 4]. Since the substance is inorganic with a very low water solubility and no log Pow value, it does not meet either criteria. However, it is generally accepted that dermal absorption is not higher than oral absorption. Therefore, the dermal absorption of Aluminium magnesium oxide is considered to be 10% for risk assessment purposes, equal to oral absorption. [2]
Once absorbed, distribution of the test substance throughout the body is not expected based on its very low water solubility. After uptake, it is not expected that Aluminium magnesium oxide is metabolized, as it is an inorganic substance. Excretion will take place via urine and faeces. [3] Bioaccumulation is expected to be limited.
References:
Ref. 1 Martinez MN, Amidon GL. Mechanistic approach to understanding the factors affecting drug absorption: a review of fundamentals. J Clin Pharmacol 2002; 42: 620-43.
Ref. 2 Guidance for the implementation of REACH. Guidance on information requirements and chemical safety assessment. Chapter R.7c: Endpoint specific guidance. European Chemical Agency, Version 6.0 November 2016.
Ref. 3 Parkinson A. In: Casarett and Doull’s Toxicology, The basic science of poisons. Sixth edition. Ed. C.D. Klaassen. Chapter 6: Biotransformation of xenobiotics. McGraw-Hill, New York, 2001.
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