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Long-term toxicity to fish

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Key value for chemical safety assessment

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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 1999/45/EC or is assessed to be a PBT or vPvB.

The hazard assessment of the substance 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 proposed.

Furthermore, this result is in line with the results of a OECD 29 test: The transformation/dissolution concentrations of the anorganic building blocks Zn and Sn at a loading rate of 1 mg/L are far below of the chronic ERVs.

Therefore, and for reasons of animal welfare, a long-term toxicity study in fish was not necessary.