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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 in fish shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on fish. 
Safe use was shown in the CSR for all uses and environmental compartments. In addition it is not expected from the nature of the substance that long-term effects will lead to more severe effects as compared with the acute results. The substance and also one of the degradation products (2,2-Dimethyl-3-lauroyloxy-propanal) are hydrolysed very quickly upon contact with water. For the second hydrolysis product 3-aminomethyl-3,5,5-trimethylcyclohexylamine data form a long-term daphnia reproduction test (NOEC 3 mg/L) shows no significantly higher toxicity as compared with acute results (NOEC= 4.2 mg/L).
In addition the very low water solubility of SIKA Hardener LI will not lead to a high exposure of the aquatic compartment.
Therefore and for reasons of animal welfare a long-term toxicity testing in fish is not provided.

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