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Long-term toxicity to fish

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In Annex IX of Regulation (EC) No 1907/2006, it is laid down that long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on aquatic organisms. According to Annex I of this regulation, the chemical safety assessment triggers further action when the substance or the preparation meets the criteria for classification as dangerous according to Directive 67/548/EEC or Directive 1999/45/EC or is assessed to be a PBT or vPvB.

The hazard assessment of potassium iron oxide reveals neither a need to classify the substance as dangerous for the environment, nor is it a PBT or vPvB substance. Therefore, and for reasons of animal welfare, a long-term toxicity study in fish is not provided.

In spite of the fact that hydrolysis is unlikely to be a significant pathway for the breakdown of potassium ferrite, the chronic toxicity of KOH and Fe2O3 has been additionally examined. KOH is a strong alkaline substance that dissociates completely in water to K+ and OH+ [OECD SIDS 2002]. Therefore, the only possible effects would result from the pH effect which, however, will remain between environmentally expected ranges. Concerning the long-term toxicity of Fe2O3 a study is not available. However, natural baseline iron concentrations in the aquatic environment are already much higher than the reported saturation concentrations of iron oxides in the environment [ARCHE 2010]. As such it is unlikely that iron ions released from iron oxides would inhibit growth and proliferation of aquatic plants, animals or microorganisms.