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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
PBT assessment does not apply
Justification:

The PBT and vPvB criteria of Annex XIII to REACH Regulation (EC) No 1907/2006 shall not be applied to inorganic substances.

Persistence Assessment

The persistence criterion can only be applied to organic substances determining the lack of degradability of a substance which remains bioavailable. Inorganic metal compounds tend to be present in non-bioavailable forms so the key criterion for classifying inorganic metal compounds should be their capacity to transform in a bioavailable form.

Bioaccumulation Assessment

Similarly, the bioaccumulation criterion can only be applied to organic substances, based on lipid partitioning of the substances. In contrast, uptake of inorganic metals is not based on lipid partitioning. Furthermore, organisms have internal mechanisms to regulate the uptake of essential metals and to control the presence of other metals.

Toxicity Assessment

Only the toxicity criterion can be applied to inorganic metal compounds taking into account that the amount of soluble metal salts can be reduced by different media (by reducing the bioavaliable fraction of the metal). The toxicity criterion will not be fulfilled for ecotoxicity with no ecologically relevant NOECs less than 0.01 mg/L (no ecotoxicological effects observed up to the limit of water solubility). In the same way the criterion will not be fulfilled for human health toxicity, since the experimental data showed no systemic effects. Samarium oxide is neither classified for human health nor for aquatic toxicity.