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Diss Factsheets
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EC number: 701-199-3 | CAS number: -
- 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
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A fully guideline-compliant Magnusson Kligman Test (GPMT) is available (NOTOX, 1998). 1% aqueous carboxymethyl cellulose was used as a vehicle.In the main study, ten experimental animals were intradermally injected with a 2% concentration of aluminium potassium fluoride and epidermally exposed to a 50% concentration of the test substance at day 8 (for 48 hours). Five control animals were similarly treated, but with the vehicle (1% aqueous carboxymethyl cellulose) only. Approximately 24 hours before the epidermal induction (day 8) exposure all animals were treated with 10% SDS. Scabs, erythema and/or necrosis were noted at the injection sites and no skin reactions, except for some small scabs, were noted at the epidermal application sites. Two weeks after the epidermal application all animals were challenged (epidermal exposure) with a 50% test substance concentration and the vehicle using a dressing (24 hours exposure). At 24 and 48 hours after removal of the dressing, the treated sites were assessed for challenge reactions. After challenge, no skin reactions were observed in treated and control animals.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The airway sensitisating potential of an aerosol of aluminium potassium fluoride was studied in Brown Norway rats (TNO, 2004a). One group of 6 female rats was exposed to a target concentration of 100 mg/m3 aluminium potassium fluoride for six hours a day for 5 consecutive days (sensitisation phase). Approximately 14 days later these animals were exposed to the same concentration of aluminium potassium fluoride for 30 min (challenge phase). Two control groups, also of 6 female BN rats each, were used. One group was sensitised only, the other group was exposed to air during the sensitisation phase and challenged to 100 mg/m3 for 30 min approximately 14 days later. The day after challenge hyperresponsiveness to methacholine was tested in all animals; two days after challenge the animals were necropsied. To examine possible allergenicity of aluminium potassium fluoride, total and specific IgE levels, breathing pattern and frequency during challenge, hyperresponsiveness to methacholine one day after challenge, and histopathology of the respiratory tract and bronchoalveolar lavage fluid measurements two days after challenge were carried out.
No treatment-related abnormalities were observed. Also no changes in body weight gain and organ weights were noted.
No increases in specific IgE levels or treatment-related changes in cholinergic hyperresponsiveness upon methacholine challenge were noted. There were also no changes in breathing frequency and pattern during challenge, suggesting that aluminium potassium fluoride is not a respiratory tract sensitiser. Repeated inhalation of aluminium potassium fluoride induced histopathological changes in the nasal passages, larynx, and lungs. Focal olfactory epithelial degeneration, necrosis and regeneration were observed in the nasal passages. In the larynx, there was a focal granulomatous inflammation. In the lungs, alveolar bronchiolisation and typical alveolar macrophage accumulations were seen. Sensitised animals exhibited a significantly increased percentage of neutrophils and a significantly decreased percentage of ofeosinophils in bronchoalveolar lavage fluid.The tested concentration of 100 mg/m3 for both sensitisation as well as challenge phases was therefore considered sufficiently high enough in view of the observed histopathological and bronchoalveolar lavage fluid changes.
Justification for classification or non-classification
Aluminium potassium fluoride is not a skin and respiratory tract sensitiser. In accordance to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification is not necessary for sensitisation.
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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