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:
insufficient hazard data available (further information necessary)

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

As defined in Part B, Section 1 of the Chemical Safety Report, the substance is an inorganic compound with very low solubility. Therefore, there are no mandatory testing requirements for any of the required ecotoxicological endpoints. As a result, the determination of PNEC levels for this substance that are based on ecotoxicological studies cannot be conducted.

A transformation/dissolution test according to OECD 29 with the substance, however, demonstrated that small amounts of the individual inorganic building blocks of this substance (i.e., the elements Nickel and Antimony) could be released in aqueous media. It was shown in a screening test that the highest release of Ni occurred at pH 6, whereas no significant differences were observed for Sb at pH 6 and 8.5. Therefore, it was decided to conduct the full test at the most relevant pH with respect to ecotoxicology, i.e. at pH 6. Furthermore, Sb is of no eco-toxicological relevance compared to Ni given by the available aquatic endpoints derived from test with aquatic organisms: The acute and chronic ERV (environmental reference value) for Antimony is 1770 and >1000 µg Sb/L, respectively (European Union Risk Assessment Report, 2008, see: https://echa.europa.eu/documents/10162/13630/trd_rar_sweden_diantimony_trioxide_en.rtf). For Ni the acute ERV is 68 and 120 µg Ni/L for high and acidic pH value, respectively and the chronic ERV is 2.4 µg Ni/L for acidic and alkaline pH values. The acute and chronic (ERVs) which are comparable to the most sensitive aquatic ecotoxicological endpoint were taken from a document of the Nickel Consortia, 2010: Environmental Read-across approach. Please see attachment, chapter 13. The third inorganic building block titanium was not taken into account here since it is not of any ecotoxicological relevance.

Conclusion on classification

The transformation and dissolution of Ni and Sb from the substance was evaluated according to the T/D Protocol (OECD 29) (transformation/dissolution protocol, see section 4.8).

The full test was performed at 1, 10 and 100 mg/L loadings for 7 days and at 1 mg/L loading for 28 days and at the pH of maximum release of the most eco-toxicological relevant metal, i.e. Ni at pH 6.

The acute and chronic Ecotoxicity Reference Values (ERVs) for Ni were taken from a document of the Nickel Consortia, 2010: Environmental Read-across approach (attached, chapter 13). The acute ERV is 68 and 120 µg Ni/L for high and acidic pH value, respectively and the chronic ERC is 2.4 µg Ni/L for acidic and alkaline pH values. The mean Ni concentration of three replicates/concentrations was 0.6, 2.8 and 24.6 µg Ni/L at a loading rate of 1, 10 and 100 mg/L and after 7 days.

The acute and chronic ERV of Antimony is 1770 and >1000 µg Sb/L and were taken from the European Union Risk Assessment Report. The mean Sb concentration of three replicates/concentrations was 1.6, 2.1 and 7.7 µg Sb/L at a loading rate of 1, 10 and 100 mg/L and after 7 days.

Consequently, the concentrations of Ni and Sb are far below the acute ERVs of 68 and 120 µg/L for Ni and 1770 µg/L for Sb and thus, the compound has not to be acutely classified according to GHS. This is in line with the available aquatic ecotoxicological studies: In short-term toxicity studies, performed with the test substance, no effect were observed up to the limit dose and the following L(E)C50 values were determined (nominal concentrations): LC50 (fish) > 10000.0 mg/L, EC50 (daphnia) > 100.0 mg/L and EC50 (algae) > 100.0 mg/L.

Based on these results, the test substance is not considered to be classified for acute aquatic toxicity.

According to theT/D Protocol (OECD 29), the solubility equilibrium has been established for Nickel at the loadings of 1 mg/L, 10 mg/L and 100 mg/L because the concentrations of the last three sampling points do not differ by more than 15%. These requirements are also fulfilled for Antimony for 1 mg/L loading. After 28 days, the mean measured concentrations were 0.48 and 1.86 µg/L for Ni and Sb, respectively. These concentrations are far below the chronic ERVs (2.4 µg Ni/L and > 1000 µg Sb/L) and thus no chronic classification has to be applied to the substance according to GHS.

In conclusion, the results according to the T/D Protocol compared with the ERVs for the most ecotoxicological relevant metals of the substance shows that the substance has not to be classified according to GHS.