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Toxicological information

Endpoint summary

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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Genetic toxicity data are not available for zinc difluoride. However, studies conducted with soluble zinc and fluoride substances were included in the dossier. In conclusion no mutagenic / genotoxic effects were observed in relevant in vitro tests.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Reliable substance-specific information concerning the toxicity for zinc difluoride does not exist. Instead, toxicological information on fluorides (mainly sodium fluoride) substances and soluble inorganic zinc substances were extrapolated to zinc difluoride considering that the systemic effects mainly based on the concentrations of the Zn2+ and F- ions which are the key concern of zinc difluoride. The detailed read-across approach is attached on IUCLID 0 "category.

Zinc(II):

Genotoxicity studies conducted in a variety of test systems have failed to provide evidence that zinc is mutagenic. “Exposure to zinc does not increase mutation frequencies in the majority of bacterial or mammalian cell culture test systems (Nishioka, 1975; Amacher & Paillet, 1980; Kada et al., 1980; Gocke et al., 1981; Marzin & Vo, 1985; Rossman et al., 1987; Thompson et al., 1989; Karlsson et al., 1991)” (WHO report, 2001). This conclusion is supported by the ATSDR (2005) and the EFSA (2012) conclusion.

 

Landsiedel et al. (2010) evaluated the genotoxic potential of zinc oxide and titanium dioxide in several standard test methods covering different endpoints. No genotoxicity was observed in vitro (Ames’ Salmonella gene mutation test and V79 micronucleus chromosome mutation test) or in vivo (mouse bone marrow micronucleus test and Comet DNA damage assay in lung cells from rats exposed by inhalation).

Fluoride:

While both positive and negative results have been reported for fluoride in vitro, the reliable in-vivo studies indicate that fluoride salts do not interact directly with DNA and are not genotoxic when administered by an appropriate route of exposure.

Justification for classification or non-classification

Mutagenic / genotoxic effects were not observed in relevant in vitro tests with soluble inorganic zinc substances and fluorides (i.e., potassium and sodium fluoride). A similar conclusion is derived for zinc difluoride since potential effects would be regarded to as zinc-ion and fluoride-ion related effects. Hence, classification and labelling of zinc difluoride is not required.