Registration Dossier

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Administrative data

acute toxicity: oral
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because a study on acute toxicity by the inhalation route is available
Justification for type of information:
Lutetium-yttrium oxyorthosilicate, cerium doped is an inorganic material that is manufactured from the underlying metal oxides by the Czochralski technique. As starting materials metal oxides of the following metals are used: Lu, Y, Si, Ce. Referring to the results of the water solubility test (see IUCLID endpoint 4.8 of the technical dossier) only (very) low metal concentrations have been detected during and after the 36-day solubilisation phase. In order to prove that even these low concentrations pose no hazards after a short-term exposure via oral route (e.g. after incidental swallowing), classifications of the underlying metals/metal oxides – as indicated in the registration dossiers and C&L notifications - are taken into account [1 - 7]. The cited classifications underline the absence of acute toxicological properties for the metals/metal oxides in lutetium-yttrium oxyorthosilicate, cerium doped. Considering furthermore the appearance of lutetium-yttrium oxyorthosilicate, cerium doped - in particular the sizes of the grown crystal and the cut smaller crystals - it can reasonably be stated that oral uptake is not the most probable route of exposure. During handling and use of lutetium-yttrium oxyorthosilicate, cerium doped at industrial sites oral uptake for workers can be regarded as not relevant. Since lutetium-yttrium oxyorthosilicate, cerium doped is also not relevant for any subsequent service life, oral uptake for consumers can be excluded. Against this background and in conformity with ECHA`s principle of avoiding unnecessary animal testing, performance of a study on acute oral toxicity is considered to be not required under Regulation (EC) No 1907/2006 (REACH).[1]: Entry in C&L Inventory Database for lutetium oxide:[2]: Entry in C&L Inventory Database for lutetium:[3]: Dossier on yttrium oxide, submitted by the registrant:[4]: Dossier on silicon dioxide, submitted by the registrant:[5]: Dossier on silicon, submitted by the registrant:[6]: Dossier on cerium dioxide, submitted by the registrant:[7]: Dossier on cerium, submitted by the registrant:

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Applicant's summary and conclusion

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