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Diss Factsheets
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EC number: 215-105-9 | CAS number: 1302-67-6
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Remarks:
- rat
- Data waiving:
- other justification
- Justification for data waiving:
- the study does not need to be conducted because the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and there is no or no significant human exposure
- Justification for type of information:
- Justification for waiving of developmental toxicity testing (Spinel) According to section 1 of REACH Regulation (EC) Annex XI, testing for pre-natal developmental toxicity does not need to be conducted if testing does not appear scientifically necessary. Aluminium is firmly bound in the Spinel lattice such that it does not have a relevant solubility which is a precondition for bioavailability. This was confirmed by solubility tests in physiological media (lung surfactant and digestive tract). Solubilisation is usually required for absorption across biological membranes, i.e. poorly soluble forms of minerals have per se also low bioavailability for their respective ions. Due to the insolubility of Spinel in the digestive tract, systemic toxicity after oral uptake is not to be expected from this substance. Bioavailability is the main important factor that affects oral toxicity of a chemical substance. It is defined as the fraction of an ingested dose that crosses the gastro-intestinal epithelium and becomes systemically available for distribution to internal target tissues and organs. Since the gut wall presents a substantial barrier to prevent uptake of metal ions from food in general and of non essential ions in particular the respective solubility of Spinel was tested. These in vitro tests in intestinal liquid with the Spinel mineral asserted the bioinert character of the test substance. Considering the above mentioned factors, Spinel is obviously devoid of toxicity via the oral route, i.e. developmental toxicity is no relevant toxicological endpoint. The other most appropriate route of exposure to Spinel is the inhalative one which is also of no relevance due to the bio-inertness of the Spinel mineral. The determined bioaccessiblity of aluminium for Spinel in the lung is 1.11 x 10-4 %. Assuming a respiratory volume of ca. 10 m3 per worker’s shift, a blood volume of ca. 5 l, and an occupational exposure limit (OEL-TWA) of 10 mg/m3 for total (inert) dust (respirable fraction; TRGS 900: Technical Guidance for dangerous substances: Airborne exposure limits), the mass of aluminium that could be solubilised in the lung would be ca. 0.022 μg/l of blood. The normal serum concentration of aluminium (background value) of the average adult is 1 to 2 μg/l, i.e. more than very roughly 40 times the potential additional “burden”. Therefore, it clearly follows that the potential systemic increase of aluminium from inhalation of Spinel is marginal. Considering the above mentioned factors, Spinel is obviously devoid of toxicity via the oral route, i.e. developmental toxicity is no relevant toxicological endpoint. Aluminium toxicity depends on the solubility of aluminium and the presence of biologically active forms of aluminium, i.e. aluminium ions. When there is no relevant systemic exposure, there can be no response regardless of the type of toxicological endpoint. To put figures into perspective potential aluminium intake in general needs to be compared with the daily unavoidable oral intake of aluminium from foodstuff which is approximately 20-40 mg per person and also with the ADI of 1 mg/kg which is thought by WHO`s JECFA to be without any health concern. For developmental toxicity of the Spinel mineral, the aluminium ion (the metal ion of toxicological concern in the Spinel crystal lattice) will have to be made bioavailable to the target organs and tissues in sufficient concentration to cause the toxic effect. This requires that the aluminium will have to be bioavailable by absorption via relevant routes of exposure. It is therefore unlikely to occur with the insoluble Spinel which is not soluble in the digestive tract and in alveolar liquid. Spinel is insoluble in water and not fat soluble, consequently it is not expected to be absorbed through the skin. In particular also cations from solubilised Spinel will not be absorbed dermally.
Data source
Materials and methods
Test animals
- Species:
- rat
Results and discussion
Results (fetuses)
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
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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