Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vitro
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
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. Appropriate application of „free“ Dysprosium metal is not possible since the particles would react in contact with water and air. In addition 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.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.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion