Registration Dossier

Diss Factsheets

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 for bioaccumulation

Additional information

Conclusion on classification

The poorly soluble substance antimony nickel titanium rutile is evaluated by comparing the dissolved metal ion levels resulting from the transformation/dissolution test after 7 and 28 days at a loading rate of 1 mg/L with the lowest acute and chronic ecotoxicity reference values (ERVs) as determined for the (soluble) metal ions Acute and chronic ERVs are based on the lowest EC50/LC50 and NOEC/EC10 values for algae, invertebrates and fish, respectively. The ERVs were obtained from the Metals classification tool (MeClas) database as follows:


The acute ERVs of antimony (12.1 mg Sb/L, ECHA disseminated database) and titanium (> 100 mg Ti/L) ions are above 1 mg/L and thus a concern for short-term (acute) toxicity was not identified (no classification). According to ECHA Guidance on the Application of the CLP Criteria (Version 5.0, July 2017), “Where the acute ERV for the metal ions of concern is greater than 1 mg/L the metals need not be considered further in the classification scheme for acute hazard.” The acute ERVs for nickel at pH 6 and pH 8 are 286 µg Ni/L and 146 µg Ni/L, respectively, and are thus well above the dissolved nickel concentration of 0.598 µg Ni/L, measured after 7 days T/D test at a loading of 1 mg/L and pH 6, the pH that maximises dissolution. Due to the lack of an acute aquatic hazard potential for soluble antimony and titanium ions and the fact that the dissolved nickel concentration measured in the T/D test after 7 days at pH 6 (pH that maximises dissolution) is significantly lower than the short-term ERVs for nickel, it can be concluded that the substance antimony nickel titanium rutile is not sufficiently soluble to cause short-term toxicity at the level of the acute ERVs (expressed as EC50/LC50).


 


Studies on the acute toxicity of antimony nickel titanium rutile to Daphnia magna (BASF AG, 1999 and MOE Japan, 2001), Leuciscus idus and Oryzias latipes (BASF AG, 1988 and MOE Japan, 2001), and Desmodesmus subspicatus and Pseudokirchneriella subcapitata (BASF AG, 2001 and MOE Japan, 2001) support this conclusion since acute toxic effects were not observed at test concentrations ranging from 1 mg/L up to 10,000 mg/L (nominal).


 


In accordance with Figure IV.4 “Classification strategy for determining acute aquatic hazard for metal compounds” of ECHA Guidance on the Application of the CLP Criteria (Version 5.0, July 2017) and section 4.1.2.10.2. of Regulation (EC) No 1272/2008, the substance antimony nickel titanium rutile is poorly soluble and does not meet classification criteria for acute (short-term) aquatic hazard.


 


Regarding the long-term toxicity, the chronic ERVs of antimony (1.130 mg Sb/L) and titanium (> 100 mg Ti/L) ions are above 1 mg/L, and a concern for long-term (chronic) toxicity was not identified (no classification). According to ECHA Guidance on the Application of the CLP Criteria (Version 5.0, July 2017), ”Where the chronic ERV for the metal ions of concern corrected for the molecular weight of the compound (further called as chronic ERV compound) is greater than 1 mg/L, the metal compounds need not to be considered further in the classification scheme for long-term hazard.” The chronic ERV for nickel at pH 6 and pH 8 are 23 µg Ni/L and 6 µg Ni/L, respectively, and are thus well above the dissolved nickel concentration of 0.480 µg Ni/L, measured after 28 days T/D test at a loading of 1 mg/L and pH 6, the pH that maximises dissolution. Due to the lack of an chronic aquatic hazard potential for soluble antimony and titanium ions and the fact that the dissolved nickel concentration measured in the T/D test after 28 days at pH 6 (pH that maximises dissolution) is significantly lower than the long-term ERVs for nickel, it can be concluded that the substance antimony nickel titanium rutile is not sufficiently soluble to cause long-term toxicity at the level of the chronic ERVs (expressed as NOEC/EC10).


 


Studies on the chronic toxicity of antimony nickel titanium rutile to Daphnia magna (MOE Japan, 2001), Desmodesmus subspicatus and Pseudokirchneriella subcapitata (BASF AG, 2001 and MOE Japan, 2001), support this conclusion as chronic toxic effects were not observed at test concentrations ranging from 1 mg/L up to 100 mg/L (nominal).


 


In accordance with Figure IV.5 „Classification strategy for determining long-term aquatic hazard for metal compounds “of ECHA Guidance on the Application of the CLP Criteria (Version 5.0, July 2017) and section 4.1.2.10.2. of Regulation (EC) No 1272/2008, the substance antimony nickel titanium rutile is poorly soluble and does not meet classification criteria for chronic (long-term) aquatic hazard.


 


In sum, the substance antimony nickel titanium rutile is poorly soluble and does not meet classification criteria of Regulation (EC) No 1272/2008 for acute (short-term) and chronic (long-term) aquatic hazard.