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EC number: 272-702-7
CAS number: 68909-34-2
A qualitative judgement on the toxicokinetic behaviour was performed
based on physico-chemical characteristics. Zirconium Dioxide is an
inorganic substance and thus some physico-chemical characteristics (like
the octanol/water partition coefficient) are not defined, limiting the
possibilities of a qualitative assessment.
Absorption factors of 10% are proposed for oral, inhalation and dermal
absorption, representing default values of what is considered still
defendable based on the limited physical/chemical data that can be
applied for inorganic substances and following the lowest proposed
default dermal absorption factor of 10% based on physical/chemical
properties (ECHA Endpoint specific guidance, Chapter R.7c; section
R.18.104.22.168, Dermal absorption). It is recognised that the actual
absorption factors for Zirconium Dioxide will be much lower. Data on
Zirconium dichloride oxide in mouse and rat show oral absorption to be
at levels of 0.01 to 0.05% of the administered dose (Delongeas JL et
al., Toxicité et pharmacocinétique de l'oxychlorure de zirconium chez la
souris et chez le rat; J. Pharmacol (Paris) 1983, 14, 4, 437-447). This
well water soluble compound could be regarded as a reference for
Zirconium dioxide as it will instantaneously be converted to Zirconium
dioxide in aqueous solution.
The available toxicological data provide no reason to deviate from the
above absorption factors, but might also indicate significantly lower
absorption factors than proposed as the substance has no eye and skin
irritating potential, is not a skin sensitizer and is of low acute
toxicity. In addition the available repeated dose studies show no
systemic effects at the highest dose tested.
Based on available physico-chemical data, relevant parameters like
tissue affinity, ability to cross cell membranes and protein binding are
difficult to predict. No further assessment is thus done for the
distribution of the substance through the body.
Olmedo et al. studied the dissemination of Zirconium dioxide after
intraperitoneal administration of this substance in rats. The
histological analysis revealed the presence of abundant intracellular
aggregates of metallic particles of Zirconium in peritoneum, liver, lung
and spleen (Olmedo, D., M.B. Guglielmotti and R.L. Cabrini. An
experimental study of the dissemination of Titanium and Zirconium in the
body; Journal of Materials Science: Materials in Medicine, Volume 13,
Number 8, 2002).
Additional data show distribution of several different zirconium
compounds through the body with main presence in bone and liver, but
also in spleen, kidney and lungs (Spiegl et al, 1956, Hamilton, 1948
(Hamilton, J.G. The Metabolic Properties of the Fission Products and
Actinide Elements, University of California, Radioation Laboratory,
W-7405-eng-48A-I, 1948) and Dobson et al., 1948 (Dobson, E.L. et al.,
Studies with Colloids Containing Radioisotopes of Yttrium, Zirconium,
Columbium and Lanthaum: 2. The Controlled Selective Localization of
Radioisotopes of Yttrium, Zirconium, Columbium in the Bone Marrow, Liver
University of California, Radioation Laboratory, W-7405-eng-48A, 1948)).
These data should be treated with care as substances were mainly
administered via injection and thus not only the chemical but also the
physical form which becomes systemically available might be different
compared to administration via the oral, dermal or inhalation route.
Based on available physico-chemical data it is difficult to predict
whether the main route of elimination (after absorption) will be via the
kidneys or bile. Data on Zirconium dichloride oxide, a soluble form,
suggest that absorbed Zirconium will be excreted via the kidneys
(Delongeas et al., 1983).
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