Registration Dossier
Registration Dossier
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EC number: 231-954-8 | CAS number: 7782-41-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Overview
Genotox data for fluorine are not available. Under physiological conditions, fluorine will react instantly and violently under formation of hydrogen fluoride. Hydrogen fluoride will reach its possible targets only as (partly organically bound) fluoride and therefore studies with other inorganic fluoride, such as NaF, will provide insight in fluoride genotoxicity and will also be applicable to fluorine.
Genetic toxicity in vitro
No evidence of mutagenicity was seen with sodium fluoride in an Ames test (NTP, 1990). No evidence of mutagenicity was seen in a mammalian cell mutation assay (V79/HPRT) with sodium fluoride. This study was performed only in the absence of metabolic activation, however this deviation is not considered to be critical as the test substance is not metabolised. A positive result with sodium fluoride is reported in a mouse lynmphoma assay (NTP, 1990). Sister chromatid exchange and chromosomal aberrations are reported in an additonal NTP study.
Genetic toxicity in vivo
Zeiger et al (1994) report no
evidence of clastogenicity, even at dose levels causing severe toxicity,
in a well-conducted mouse study performed with sodium fluoride in which
chromosomal aberrations and micronucleus formation was assessed.
Justification for classification or non-classification
No classification is proposed. The available data indicate that fluoride does not interact directly with DNA and is not genotoxic when administered via an appropriate route. Data therefore indicate that the substance is unlikely to be genotoxic.
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