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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 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 diisopropanolamine 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.

Therefore, and for reasons of animal welfare, a chronic test on fish is not provided.

Moreover, in accordance with Regulation (EC) No.1907/2006, Annex 1, Section 6.4, the chemical safety assessment for 1-(2-hydroxypropylamino)propan-2-ol demonstrates that 1) the exposure levels estimated in all relevant scenarios do not exceed the appropriate PNEC, and 2) the likelihood and severity of an event occurring due to the physicochemical properties of the substance in the aquatic environment are negligible; therefore, the criteria for adaptation are met. Specifically, all risk characterization ratios are under 1.0; and there are no physicochemical hazards identified for this substance in the aquatic environment. Therefore, long-term aquatic toxicity testing on fish is not indicated.