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Long-term toxicity to fish

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Testing for long-term toxicity to fish is not considered necessary because:

In accordance with Column 2 of REACH Annex IX, there is no need to further investigate the effects of this substance in a long-term aquatic toxicity to fish study because, as indicated in guidance R.7.8.4.3 (ECHA 2016), the quantitative chemical safety assessment (conducted according to Annex I of REACH) indicates that further testing is not justified for the following reasons:  

A PNEC has been derived for the purpose of chemical safety assessment and the risk characterisation ratios are below 1.

The substance is highly water-soluble, has low bioavailability based on log Kow <3 (-4.0 (corrected for ionisation)), especially in pH neutral conditions, and evidence from data available within the analogue group of amine substances suggests that fish are the least sensitive trophic level.

The substance has short-term data available for three trophic levels, as well as long-term invertebrate toxicity data. Based on this available aquatic data the most sensitive trophic level is algae which is more toxic by a factor of two to three hundred.  Furthermore, effects observed in the short-term toxicity to fish test occurred when the substance was tested at high concentrations, well above 100 mg/l.

Overall it is concluded that the risk is adequately assessed using the short-term data and the long-term invertebrate test, and that in vivo testing on vertebrate animals is not considered necessary or justified on ethical grounds.

Details on how the PNEC and the risk characterisation ratio have been derived can be found in IUCLID Section 6.0 and Chapters 9 and 10 of the Chemical Safety Report, respectively.