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Long-term toxicity to aquatic invertebrates

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In accordance with column 2 of REACH Annex IX, the test on long-term toxicity to aquatic invertebrates (required in section 9.1.5) was waived, as the chemical safety assessment indicates no need for further testing. Indirect exposure to sediment and water via sewage sludge transfer to soil and leaching is unlikely since the substance is ultimatively biodegradable. For a substance being considered as „readily biodegradable“, it can be assumed that it will be biodegraded within the STP process and as a consequence a transfer to sediment compartment is not expected. Therefore, no tests on long term toxicity to aquatic invertebrates are provided.
In addition, 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 ureido methacrylate reveals neither a need to classify the substance as dangerous for the environment, nor is it a PBT or vPvB substance, nor are there any further indications that the substance may be hazardous to the environment. Therefore a long-term toxicity study in aquatic invertebrates is not provided.

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