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EC number: 483-360-5
CAS number: 114435-02-8
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.
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
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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