Registration Dossier

Diss Factsheets

Administrative data

Link to relevant study record(s)

Description of key information

Only standard information required at REACH Annex VIII is available for assessing the toxicokinetics for the test substance. The available test data do not permit extensive conclusions concerning absorption, metabolism or excretion to be conclusively drawn.

Key value for chemical safety assessment

Bioaccumulation potential:
low bioaccumulation potential

Additional information

Repeated oral administration of the test substance in an OECD 407 study to rats provided a NOAEL of 10 mg/kg/day based on local effects observed in the stomach. In the available OECD 421 study, similar effects were observed in the stomach but also noted was fluorosis in the teeth at the high and intermediate doses which led to a NOAEL of 5 mg/kg/day. This indicates metabolism of the substance followed by systemic circulation with fluorine able to lead to fluorosis in the teeth.

Based on the relatively low Log Kow values (<4.5), bioaccumulation of the test substance is not expected.

Acute oral toxicity of the test substance was observed (LD50 500 mg/kg).

No treatment related changes were observed in any of the developmental or reproductive parameters in the OECD 421 study, possibly indicating low adsorption through the placenta to directly affect the foetuses. Pups presented with low bodyweights compared to controls although this is considered a secondary effect of parental toxicity at the highest dose tested. It is not clear if exposure of the substance to pups via lactation occurred.

The single dose in vivo micronucleus study in mice indicated the substance was cytotoxic to bone marrow cells, but did not show any indication of chromosomal damage.