Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no hazard identified

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Conclusion on classification

Studies performed with the substance

In 3 short-term studies performed in accordance with the current OECD guidelines, up to a concentration present in a 0.45 μm filtered solution prepared at a loading rate of 100 mg/L, the substance did not induce visible or lethal effects in carp, did not induce acute immobilisation of Daphnia magna and did not reduce the growth rate of Pseudokirchneriella subcapitata.

Metals strategy

The substance is an inorganic metal substance. Consequently any classification based on the metals strategy presented in the Guidance on the Application of the CLP criteria should also be investigated. Following the guidance, consideration should be given to the level of the metal ion which may be present in solution following the addition of the metal compound. In case of this particular substance there are three metals to consider, Ca, Sb and Mn. The acute toxicity values for calcium ion are greater than 100 mg/L. Based on this information, any classification based on Mn and/or Sb ion needs to be investigated only. The rate and extent of transformation of these 2 elements from the substance must be considered.

The water solubility data show that the concentration of Sb and Mn in a with the substance saturated water phase is below 1 µg/L (the detection limit). From the ecotoxicity studies followed that the concentration of Sb and Mn remained low (below 10 µg/L) and constant over time (<1 µg Mn/L at t=0 up to 2.22 µg Mn/L at t=48 hours and 5.74 µg Sb/L at t=0 up to 7.23 µg Sb/L at t=96 hours). It must be noted that Sb and Mn are measured in these studies as part of the substance, in their non-dissociated form, as well as dissociated ions, if applicable, because the used analytical method (ICP-MS) does not distinguishes their forms as present in water. The measured Sb and Mn concentrations may therefore also origin from the substance.

Based on this supportive data, showing that the rate and extent of transformation of these metal ions from the substance is low (and slow), if any, it is not considered needed to obtain more information, by following the Transformation/Dissolution Protocol. It is concluded that there is enough information to assess the environmental classification of the substance.

Conclusion

Based on all the available information, the substance does not need to be classified for the environment and performing a study with the substance using the Transformation/Dissolution Protocol is not regarded needed. The rate and extent of transformation of the relevant ions Mn and Sb from the substance has been shown to be negligible, if any, based on the already available information.