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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 CLP Regulation (EC) No 1272/2008 or is assessed to be a PBT or vPvB.

The hazard assessment of the mixture "oxirane, reaction products with ammonia, distn. residues" reveals neither a need to classify the substance as dangerous for the environment, nor is it a PBT or vPvB substance.

The ACR approach according to ECETOC No. 91 (2003) indicates that a chronic NOEC would be greater than 1 mg/L. The results from short-term toxicity tests on fish, Daphnia and algae demonstrate that D. magna is 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.

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