Registration Dossier

Administrative data

Description of key information

Skin irritation:

In a study scored as K2 (Solvay, 2016), the pH-value of a 10% Samarium trinitrate solution was determined to be = 1.95 and its acidic reserve, determined via titration, was found to be 0.41. Thus, the calculation for corrosivity of the Samarium nitrate was 1.92 that is well above the threshold of -0.5 to consider a substance as corrosive. Therefore, Samarium trinitrate was considered not to be corrosive to the skin.

No further data is available on the substance for the skin irritation/corrosion end-point. However, based on the above mentioned study and based on reliable available results on other Rare Earth nitrates obtained either, using in vivo skin irritation studies performed according to OECD Guideline n° 404 or comparable guidelines (Cerium trinitrate, Lanthanum trinitrate, Neodymium trinitrate, Praseodymium trinitrate, Yttrium trinitrate and Terbium trinitrate), or using in vitro skin irritation/corrosion studies performed according to OECD Guideline n°431 and/or OECD guideline n° 439 (Gadolinium trinitrate, Dysprosium trinitrate, Lanthanum trinitrate, Neodymium trinitrate, Preseodymium trinitrate, Ytterbium trinitrate and Lutetium trinitrate), which all have shown no skin irritation of these tested substances, it is expected that Samarium trinitrate will not cause corrosion and irritation of the skin. Thus, Samarium trinitrate needs not to be classified according to CLP criteria. No further testing to cover this endpoint is deemed to be required.

Eye irritation:

No data is available on the substance for the eye irritation end-point. However, reliable available studies performed with other Rare Earth nitrates (done using, either in vivo eye irritation studies performed according to OECD Guideline n° 405 or comparable guidelines (Cerium trinitrate, Lanthanum trinitrate, Neodymium trinitrate, Yttrium trinitrate and Terbium trinitrate), or using in vitro eye irritation/corrosion study performed according to OECD Guideline n°437 (Gadolinium trinitrate), have shown that all these Rare-Earth nitrates have induced serious eye damage and thus, have been classified in the Category 1 with the hazard statement H318 “ Cause serious eye damage” according to CLP.

Based on these results, it is expected that Samarium trinitrate will cause serious eye damages and thus, needs to be classified in the Category 1 with the hazard statement H318 "Cause serious eye damage" according to CLP. No further testing to cover this endpoint is deemed to be required.

Key value for chemical safety assessment

Additional information

Justification for classification or non-classification

The available data are sufficient to not classify Samarium trinitrate for skin irritation.

Using the Weight of Evidence approach, Samarium trinitrate is considered as a substance causing eye damage Category 1 and needs a H318 hazard statement according to CLP.