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EC number: 231-176-9
CAS number: 7440-67-7
As Zr and ZrO2 are
expected to give similar toxicological effects (owing to their
behaviour), a read across with ZrO2 is performed. Zirconium dioxide
shows limited toxicological effects as highlighted by the acute toxicity
studies via oral and inhalation route, as well as by the repeated dose
toxicity studies via inhalation.
information indicates no adverse effects on reproductive organs or
tissues. Two reliable studies on ZrO2 were available for this endpoint
(Klimisch 2): a 30 day repeated dose inhalation test in dog, rabbit and
rat and a 60 day repeated dose toxicity test in cat, dog, guinea pig,
rabbit and rat. No effects were reported in any of the species studied
after inhalation of ZrO2 dust (NOAEC > 75 mg Zr/m3 air in the 30 day
study and NOAEC >11 mg Zr/m3 air in the 60 day study), with no abnormal
findings noted for the reproductive organs.
In another study,
realised with a poorly soluble zirconium substance, zirconium basic
carbonate (ZBC) (Harrisson et al., 1951), rats were exposed to a diet
containing ZBC for 17 weeks and did not find any effects on the genital
It is interesting to
mention that in the study by Spiegl et al. (1956), exposure to zirconium
tetrachloride dissolved into water, so in the form of zirconium
dichloride oxide was as well realized. Sixty animals were exposed during
60 days at 6 mg Zr/m3. In this study, testicular atrophy in 2 cats was
observed. An additional study on zirconium dichloride oxide (ZOC) was
done by oral route by Delongeas et al. (1983). This study showed that a
weak fraction of Zr was absorbed after oral exposure of rats to ZOC
(3000 and 5300 mg/kg). However a small portion of this absorbed fraction
could reach the ovaries and induce hypervascularization.
Based on these results
we can suppose that there may be a difference between soluble and poorly
soluble Zr compounds and conclude that for an insoluble compound of
zirconium such as zirconium dioxide the effects on reproductive organs
and the toxicity to reproduction are limited. However, this does not
provide sufficient data to justify a lower priority for testing for
effects on development. Therefore, a teratology study (OECD 414) is
proposed in the frame of ZrO2 dossier.
The results of this test will provide data on the effects of the
substance on implantation, resorptions, foetal growth, morphological
variations and malformations.
Consequently, in case
of clear negative results, any additional testing is deemed not relevant
and it can then be concluded that zirconium dioxide will not be toxic to
reproduction. In case of any positive results in the teratogenicity
study, more information on toxicity to reproduction would be necessary
as well and would subsequently be investigated in an OECD 416 study.
results of the ZrO2 test is available, an update of the Zr dossier will
Based on the same behaviour and toxicological effects, a read across with ZrO2 was relevant. As this testing proposal is already made in the frame of ZrO2 dossier, a supplementary teratogenicity testing does not need to be proposed for Zr metal but read-across to the study on ZrO2 will be made.
Zr and ZrO2 are
expected to give
read across with
relevant. As a
testing proposal for
the evaluation of
the teragenicity (OECD
414) is already
made in the
frame of ZrO2
testing does not
need to be
proposed for Zr
the study on
ZrO2 will be
the results of
the ZrO2 test is
update of the Zr
dossier will be
Based on the available
data, the substance was not classified under the CLP Regulation
1272/2008 and the directive Classification and Labeling 67/548.
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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