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Diss Factsheets
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EC number: 913-353-9 | 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
A negative Ames test, a negative study of cytogenicity in V79 cells in vitro and a negative study of gene mutation in V79 cells in vitro are available for calcium difluoride. Some positive studies in vitro are reported for the more soluble sodium fluoride salt, however reliable in vivo studies are negative. The available data indicate that fluoride does not interact directly with DNA and is not genotoxic when administered via an appropriate route (i.e. by oral or inhalation exposure). Although ambiguous results were noted, by and large Sodium chloride was reported to be negative in the AMES test. The positive responses so observed does not have any relevance to handling and safety. Hence, Sodium chloride was not classified as genotoxic.No gene mutations were reported in Bacterial tests, with and without metabolic activation.
However, high concentrations of KCl showed positive results in a range of genotoxic screening assays using cells in culture.
The action of KCl in culture seems to be an indirect effect associated with an increased osmotic pressure and concentration.
Therefore, KCl do not have any direct relevance in the intact body were such concentrations can not occur.
Cryolite does not induce gene mutations in a bacterial in vitro system. In vitro tests on induction of chromosomal aberrations (human lymphocytes) and unscheduled DNA synthesis (rat hepatocytes) are reported to be negative.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
In vivo studies for Calcium difluoride are negative. The available data indicate that fluoride does not interact directly with DNA and is not genotoxic when administered via an appropriate route (i.e. by oral or inhalation exposure).
Sodium chloride was not classified as genotoxic. KCl do not have any direct relevance in the intact body were such concentrations can not occur. In vivo cryolite was negative in rat bone marrow chromosomal aberration tests after acute and repeated inhalation exposure.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Studies of bacterial mutation (Ames test), cytogenicity and gene mutation in mammalian cells are available for calcium difluoride: additional data are available for other soluble fluoride salts. S Historically, sodium chloride (as a major ingredient in edible salt) has been commonly used in cooking and as a condiment and food preservative. Sodium chloride is categorised under GRAS (Generally Recognised as Safe) by the FDA (U.S. Food and Drug Administration) and the average daily levels of sodium intake for adults range from 2 to 5 grams. Based on the above considerations, potassium chloride (KCl) was evaluated to be non-mutagenic. For Cryolite results of the assay indicated no statistically significant increase in the proportion of aberrant metaphases or total aberrations/cell at any dose level or at any time interval evaluated.
Justification for classification or non-classification
For Calcium difluoride no classification is proposed for genetic toxicity according to the CLP Regulation (1272/2008/EC). The available data indicate that fluoride does not interact directly with DNA and is not genotoxic when administered via an appropriate route (i.e. by oral or inhalation exposure). Sodium chloride is not formally classified in the EU (according to Regulation EC No. 1272/2008 Annex VI, Table 3.1 and Regulation EC No. 1272/2008 Annex VI, Table 3.2) and UN-GHS. For Potassium chloride, based on the available data no classification is proposed. For Cryolite, based on the available data and in accordance with Directive 67/548/EEC and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification is not necessary for mutagenicity.
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