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 for bioaccumulation

Additional information

The pigment zirconium praseodymium yellow zircon is virtually environmentally and biologically inert due to the characteristics of the synthetic process (calcination at high temperatures, approximately 1000°C), rendering the substance to be of a unique, stable crystalline structure in which all atoms are tightly bound and not prone to dissolution in environmental and physiological media. Based on the resulting physico-chemical properties, especially the high insolubility of the pigment under environmental conditions, demonstrated by (Grané, 2010) via transformation/dissolution testing (7 and 28 days), the substance can be expected to not have a potential to cross or adsorb to biological membranes. Therefore, no reversible or irreversible adverse toxicological effects on aquatic or terrestrial life-forms are expected, and a PNEC derivation is scientifically not justifiable.

This assumption is supported by the negative results of a toxicity test on freshwater algae on Pseudokirchneriella subcapitata that was conducted in accordance with OECD 201 and OECD Series on Testing & assessment No 23 (ie.e guidance for testing of difficult, sparingly soluble/insoluble substances). In this study, an EC10 and EC50 for growth rate and biomass could not be determined as no toxicity was observed at the tested concentration of 100.0 mg/L, conmfirming the environmental and biological inertness of this substance.

Conclusion on classification

Based on the high insolubility of the pigment under environmental conditions, demonstrated by (Grané, 2010) via transformation/dissolution testing (7 and 28 days) and the negative outcome of test performed on freshwater algae Pseudokirchneriella subcapitata (Neri, 2010) with an EC50 value >100 mg/l, no reversible or irreversible adverse toxicological effects on aquatic or terrestrial organisms are expected. Hence no environmental classification is required.