Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
Human and/or environmental exposure to elemental Dysprosium in massive form can be excluded, since at environmental conditions (air/humidity) practically insoluble substances (oxides, hydroxides) are formed immediately on the surface: Any respective investigations would be of no additional merit for the relevant scientific knowledge with regard to human and/or environmental protection. Furthermore the permanent magnets production with Dysprosium alloys takes place under strictly controlled conditions (vacuum, inert gas; see technological process) in order to ensure the high quality of the permanent magnets. Therefore exposure of humans during production of the magnets is unlikely to occur.The relevant threshold values for inert dusts for worker exposure are observed by VAC (documented measurements). No elevated dust exposure was measured.In addition the study is technically not feasible: Application of Dysprosium in massive form, which would be a prerequisite for toxicological and eco-toxicological studies, is practically not feasible. For this purpose at least Dysprosium powder would be required (see Annex XI (2)).The Lanthanide elements own a very high affinity for oxygen; they exhibit the highest free energy for oxide formation of all elements in the periodic table, accounting for the exceptional thermodynamic stability of the oxides. In consequence the metals will react with air, building up an oxide layer on the surface. This implies the technical unfeasibility of exposure to “free” Dysprosium metal (powder form), which is a prerequisite for the requested biological tests. The generation of a Dysprosium atmosphere of inhalable particle size (< 10 μm) is practically not possible. Dysprosium particles on the scale of < 10 μm would only be stable under inert gas and are capable to react vigorously (burn) with air and humidity during oxidation. Alternative administering of Dysprosium under inert gas conditions to test experimental animals is technically not feasible.Furthermore according to REACH annex V, section 1 "substances which result from a chemical reaction that occurs incidental to exposure of another substance or article to environmental factors such as air, moisture, microbial organisms or sunlight" are exempted from the obligation to register. The ignoble metal Dysprosium is due to its high reactivity (high reduction potential) with water and air not existent at ambient conditions. In air Dysprosium metal is converted to Dysprosium oxide. In contact with water Dysprosium hydroxide is immediately formed. These reaction products are exempted from REACH registration obligations.

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion