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EC number: 262-553-6 | CAS number: 60996-20-5
- 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
Description of key information
The oral LD50 exceeds 2000 mg/kg body weight.
The inhalatory LC50 (4 hours) was determined at 1 -5 mg/L for male and female rats based on read-across from multiconstituent aluminium potassium fluoride.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- GLP study according to standard guidelines.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Quality of whole database:
- GLP study according to standard guidelines.
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral route:
An acute oral toxicity study according to OECD guideline 423 and under GLP conditions is available. The test material was administered at 2000 mg/kg bw by oral gavage. Animals were observed for 14 days and necropsied. No mortality occurred. No clinical signs of systemic toxicity were noted. For this reason, the oral LD50 value of potassium cryolite in Wistar rats was established to exceed 2000 mg/kg body weight.
Inhalation route:
Since no acute inhalation toxicity study is available for potassium cryolite, the results from the structural analogue multiconstituent aluminium potassium fluoride are used instead (for details see Read-across justification as attached in section 13).
The acute inhalation toxicity of multiconsituent aluminium potassium fluoride in the rat was investigated in a GLP compliant, non-guideline study. Despite some minor restrictions in design and/or reporting, the study is considered as adequate for assessment. One group of 5 male and 5 female rats was exposed whole body to a dust atmosphere of the test substance. The duration of the exposure was 1 hour followed by a 14 day observation period. The gravimetric concentration of test article in the test atmosphere was 4.92 mg/l. Particle size analysis of the exposure chamber revealed a mass median diameter of 1.30 µm and geometric standard deviation of 1.58. Four of the test animals died during the study. Irregular breathing, poor coat quality, yellow/brown stained fur, lethargy, crusty eye, crusty nose, and crusty muzzle were observed among the test animals during the study period. Necropsies revealed no gross lesions in 5 of 10 test animals. Abnormalities of the small intestine, stomach, and heart were observed in the remaining test rats. Based on the observed mortality it can be concluded that the 1-hour LC40 of the test substance is 4.92 mg/L which would correspond to a 4-hour LC40 of 1.23 mg/l when applying Haber's rule. The 4 -hour LC50 will be slightly above this concentration.
Based on these results, the inhalatory LC50 (4h) value of potassium cryolite in rats is also expected to fall within the range of 1 - 5 mg/L.
Dermal route:
In accordance with column 2 of REACH Annex VIII-IX, as acute toxicity studies for the oral and inhalation route are available, no study regarding the dermal route is needed.
Justification for classification or non-classification
The oral LD50 of potassium cryolite is determined to be >2000 mg/kg bw in the available acute oral toxicity study. Based on these results,classification of potassium cryolite for acute oral toxicity according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 is not needed.
In the acute inhalation study with the read-across candidate multiconsituent aluminium potassium fluoride, the LC50 value was established to fall within the range of 1 - 5 mg/L. Therefore the substance potassium cryolite needs to be classified as Cat. 4, H332 'Harmful if inhaled' according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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