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EC number: 264-885-7
CAS number: 64417-98-7
Acute toxicity: oralThree reliable studies have been performed according to OECD 401 with three different batches of yttrium doped zirconia (Chemical Evaluation and Research Institute, 2001). The LD50 value derived after oral exposure to yttrium doped zirconia in the three studies is 2000 mg/kg bw.Acute toxicity: inhalationThe LC50 was higher than 4.3 mg/L (maximal technically achievable mean concentration) in male and female Crl:CD(SD) albino rats via nose-only inhalation exposure (dust aerosol of zirconium dioxide). Acute toxicity: dermalNo reliable data were available for acute toxicity via the dermal route of exposure.
reliable studies have been identified (Chemical Evaluation and Research
Institute, 2001), in which the acute toxicity of
three different batches of yttrium zirconium oxide
was determined after oral exposure in rats. The LD50 value was defined
to be > 2000 mg/kg bw in each of these studies.
Data are available for both the oral and the inhalation route of
exposure. According to the REACH Regulation, only one additional route
of exposure should be tested other than the oral route of exposure for
acute toxicity (column 2, annex VIII, section 8.5). Therefore, it is not
necessary to perform an acute toxicity study via the dermal route of
exposure with yttrium zirconium oxide.
- Based on the available data on the toxicity of yttrium zirconium oxide
after acute oral exposure and according to the CLP criteria, the
substance should not be classified for acute toxicity via the oral route
- Based on the available data on zirconium dioxide (which can be
regarded as the main component of the yttrium zirconium oxide crystal
lattice) and according to the CLP criteria, the substance yttrium
zirconium oxide should not be classified for acute toxicity via
inhalation. Although the LC50 of zirconium dioxide dust aerosol is
higher than 4.3 mg/L, which is lower than the classification cut-off
value of 5 mg/L for category 4 classification (CLP), further testing
would not be considered feasible as the maximum technically obtainable
mean concentration for exposure is 4.3 mg/L and no mortality and no
overt toxicity occurred at this concentration. Classification for acute
inhalation toxicity is therefore deemed unnecessary.
- No data are available on the acute toxicity via the dermal route of
exposure. However, since the oral LD50 was consistently > 2000 mg/kg bw
in the three available studies, and since no systemic effects have been
observed in the available in vivo studies with dermal exposure (i.e. the
in vivo skin irritation and skin sensitisation studies), yttrium
zirconium oxide can be concluded not to be classified for acute toxicity
after dermal exposure either.
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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