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Long-term toxicity to fish

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The results from short-term toxicity tests on fish, Daphnia and algae demonstrate that aquatic invertebrates are the most sensitive trophic level tested. Therefore, it may be concluded that results from a long-term test in fish would not reveal a greater hazard than already determined by the available data. To determine chronic effects of N4-Amine N,Nā€™-Bis-(3-Aminopropyl)-ethylenediamine (CAS 10563 -26 -5) on aquatic invertebrates, a GLP-study according to OECD 211 was performed with Daphnia magna (21 d-reproduction test). The NOEC was determined to be 7.2 mg/L (nominal) indicating that chronic effects on aquatic invertebrates are not expected.

In Annex IX of Regulation (EC) No 1907/2006, it is laid down that long-term toxicity test shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on fish. 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 CLP-Regulation (EC) No 1272/2008 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 to 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. Moreover, the chemical turned out to be readily biodegradable in an OECD ready test.

Therefore, and for reasons of animal welfare, a long-term toxicity in fish is not provided.