Registration Dossier
Registration Dossier
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EC number: 603-401-4 | CAS number: 1302-88-1
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: Expert assessment
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: An assessment was conducted based on an examination of the physical and chemical properties of the substance, its composition, and the toxicokinetics behaviour of its constituents.
- Objective of study:
- toxicokinetics
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- An assessment was conducted based on an examination of the physical and chemical properties of the substance, its composition, and the toxicokinetics behaviour of its constituents.
- GLP compliance:
- no
- Radiolabelling:
- no
- Type:
- absorption
- Results:
- No absorption is expected by dermal route and inhalation. Limited absorption of the ionic species released by the dissolution of the substance is expected following oral exposure.
- Type:
- distribution
- Results:
- Distribution of the absorbed species is expected mainly in bones and muscles.
- Type:
- metabolism
- Results:
- Absorbed species are not expected to metabolise.
- Metabolites identified:
- not specified
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
Considering that the substance cannot be absorbed due to its particle size, will only release a reduced amount of ionic species following oral exposure and that these species will be poorly absorbed, systemic exposure to the registered substance can be considered as inconsequential. - Executive summary:
The absence of specific toxicokinetics data from animal testing means that it is not possible to make firm conclusions concerning the absorption, distribution, metabolism or excretion of the registered substance. However, an assessment of the toxicokinetics behaviour of the species released by the limited dissolution of the substance has been performed in conjunction with an assessment of the available toxicological data.
According to the information available, the substance is not expected to be absorbed following a dermal or inhalation exposure and only some ionic species released by the limited dissolution of the substance will be absorbed following oral exposure. This limited dissolution is due to the strength of the lattice structure of the registered substance.
Components dissolved and identified during water solubility studies were aluminium, silicon, and magnesium, expected to form aluminium hydroxide, silicon dioxide, and magnesium hydroxide after their release by the substance.
Oral aluminium bioavailability in humans from aluminium hydroxide is extremely low. Absorption of silicon dioxide and magnesium oxide are also limited.
Considering that the substance cannot be absorbed due to its particle size, will only release a reduced amount of ionic species following oral exposure and that these species will be poorly absorbed, systemic exposure to the registered substance can be considered as inconsequential.
It is therefore not considered appropriate to perform further animal studies on this substance.
Reference
Description of key information
Considering that the substance cannot be absorbed due to its particle size, and will only release a reduced amount of ionic species following oral exposure and that these species will be poorly absorbed, systemic exposure to the registered substance can be considered as inconsequential.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
The absence of specific toxicokinetics data from animal testing means that it is not possible to make firm conclusions concerning the absorption, distribution, metabolism or excretion of the registered substance. However, an assessment of the toxicokinetics behaviour of the species released by the limited dissolution of the substance has been performed in conjunction with an assessment of the available toxicological data.
According to the information available, the substance is not expected to be absorbed following a dermal or inhalation exposure and only some ionic species released by the limited dissolution of the substance will be absorbed following oral exposure. This limited dissolution is due to the strength of the lattice structure of the registered substance.
Components dissolved and identified during water solubility studies were aluminium, silicon, and magnesium, expected to form aluminium hydroxide, silicon dioxide, and magnesium hydroxide after their release by the substance. Oral aluminium bioavailability in humans from aluminium hydroxide is extremely low. Absorption of silicon dioxide and magnesium oxide are also limited.
Considering that the substance cannot be absorbed due to its particle size, and will only release a reduced amount of ionic species following oral exposure and that these species will be poorly absorbed, systemic exposure to the registered substance can be considered as inconsequential. It is therefore not considered appropriate to perform further animal studies on this 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
