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EC number: 945-888-9
CAS number: -
According to REACH Annex IX, column 2,
item 18.104.22.168, "Further degradation testing shall be proposed by the
registrant if the chemical safety assessment according to Annex I
indicates the need to investigate further the degradation of the
substance." Furthermore, waiving may be considered "if the substance is
highly insoluble in water". As "zirconium oxide, hafnium and ytterbium
doped" is highly insoluble in water (see IUCLID section 4.8), the REACH
endpoint requirement 9 .2.1.2 is waived.
REACH Annex IX, column 2, item
22.214.171.124, foresees waiving if "the substance is readily biodegradable".
However, for an inorganic substance for which the chemical assessment is
based on the elemental concentration (i.e. pooling all inorganic
speciation forms), biotic degradation in the environment is an
irrelevant process. Biotic processes may alter the speciation form of an
element, but it will not eliminate the element from the environment by
degradation or transformation processes. This elemental-based assessment
(i.e. pooling all speciation forms) can be considered as a worst-case
assumption for risk assessment. Most importantly, simulation tests of
biological degradation are technically not feasible with " zirconium
oxide, hafnium and ytterbium doped". According to REACH Annex XI, point
2, the guidance given in the test methods referred to in Article 13(3),
more specifically on the technical limitations of a specific method,
shall always be respected. The test guidelines relevant for biological
degradation in surface water and/or water-sediment systems are OECD 308
and 309 (and their counterparts in EU Regulation 440/2008). The
applicability of these test methods is explicitly restricted to organic
chemicals. Therefore, as an inorganic compound, "zirconium oxide,
hafnium and ytterbium doped" falls outside the technical feasibility
domain of biological degradation testing.
Apart from that, waiving is possible
in line with REACH Annex IX, column 2, item 126.96.36.199, if a direct or
indirect exposure of the sediment compartment can be excluded. Based on
the information on identified uses, direct exposure of sediment to
zirconium oxide, hafnium and ytterbium doped is excluded. Due to the low
water solubility of the metal components contained in the test substance
(zirconium oxide, hafnium and ytterbium doped), a full
transformation/dissolution protocol was carried out to study the
potential release of these metals to the environment. After 7 and 28
days (nominal loading of 100 mg/L, pH 8), only ytterbium(III) was found
in solution with a maximum concentration of 0.069 µg/L. Zirconium and
hafnium were both below the detection limit of 0.07 and 0.02 µg/L,
respectively. Therefore, information on ytterbium(III) is relevant for
the assessment of environmental fate properties of zirconium oxide,
hafnium and ytterbium doped. Due to the extremely low water solubility
of ytterbium(III), the substance is not expected to be released from
sewage treatment plants (STPs) to receiving waters to a significant
extent. Undissolved particles are expected to be removed in the
sedimentation tank of the STP. Thus, indirect exposure of sediments is
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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