Registration Dossier
Registration Dossier
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EC number: 913-353-9 | CAS number: -
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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