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Diss Factsheets
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EC number: 236-751-8 | CAS number: 13473-90-0
- 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Studies in vitro
Studies were performed with the read-across substance aluminium sulphate.
No evidence for the induction of reverse mutation was seen in an Ames test (Verspeek-Rip, 2010) performed in S. typhimurium strains TA 98, TA 100, TA 1535 and TA 1537 and E. coli strain WP2uvrA in the absence and presence of metabolic activation and at concentrations up to the limit of 5000 µg/plate.
No evidence for the induction of micronuclei was seen in a study (Buskens, 2010) performed in cultured primary human peripheral lymphocytes in the absence and presence of metabolic activation and at concentrations exceeding the limit of solubility of the test material.
No evidence for the induction of forward mutation was seen in a mouse lymphoma assay (Verspeek-Rip, 2010) performed in L5178Y cells in the absence and presence of metabolic activation and at concentrations exceeding the limit of solubility of the test material.
The available data from high quality studiesin vitrotherefore demonstrate the absence of genotoxicity for this soluble aluminium salt.
Study in vivo
In a published study (Roy et al, 1991), repeated oral administration was reported to result in a dose-dependent inhibition of dividing cells and an increase in the number of chromosomal aberration in the bone marrow of rats exposed for up to 21 days. This published study is not considered to be of sufficient reliability and the apparently positive result is questionable given the clear absence of effects in studiesin vitroand the lack of evidence for the carcinogenicity of aluminium or its salts.
Justification for selection of genetic toxicity endpoint
A weight of evidence approach is taken to address the genotoxicity endpoint, based on the availability of three negative in vitro studies. No single study is therefore designated 'key'.
Short description of key information:
Modern, GLP- and guideline-compliant in vitro studies of bacterial mutation (Ames test), chromosomal aberration (micronucleus assay) and mammalian cell mutation (mouse lymphoma assay) are available for the read-across substance aluminium sulphate.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
No classification for genotoxicity is proposed, based on the clear negative results obtained in an appropriate battery of guideline- and GLP-compliant studies in vitro.
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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