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Administrative data

screening for reproductive / developmental toxicity
Data waiving:
other justification
Justification for data waiving:
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.For reproductive toxicity of Dysprosium, the Dysprosium ion will have to be made bioavailable to the target organs and tissues in sufficient concentration to cause the toxic effect. Bioavailability is the main important factor that affects oral toxicity of a chemical substance. It is defined as the fraction of an ingested dose that crosses the gastro-intestinal epithelium and becomes systemically available for distribution to internal target tissues and organs. This requires that Dysprosium will have to be bioavailable by absorption via relevant routes of exposure. After oral uptake, throughout transition to the duodenum (pH 8-9), dissolved Dy(III) would be precipitated to insoluble Dysprosiumhydroxide. It should be noted that the gastrointestinal absorption of soluble Dysprosium salts is < 1%. It is therefore unlikely to occur with the insoluble Dysprosium which is not soluble in the digestive tract. Thus, systemic uptake is not expected. Dysprosium is insoluble in water and not fat soluble, consequently it is not expected to be absorbed through the skin. In particular also Dysprosium cations will not be absorbed dermally.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.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. Appropriate application of „free“ Dysprosium metal is not possible since the particles would react in contact with water and air. The readily formed oxides and hydroxides are insoluble in water.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

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion