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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 chronic tests on fish 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 3-(dimethylamino)-propylamine 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.

In accordance with Regulation (EC) No.1907/2006, Annex 1, Section 6.4, the chemical safety assessment for 3-aminopropyldimethylamine 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.

However, the long-term effect was estimated using the model ECOSAR v1.11 implemented in EPISuite v4.11. The substance was within the applicability of the estimation model; but as long-term prediction by the model has been developed based on a small data pool (training set: n < 5), the modeled results have a high uncertainty. Therefore, the results of this QSAR model are disregarded.

ECOSAR v1.11: chronic value = 111 mg/L