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Long-term toxicity to fish

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Description of key information

Long-term toxicity testing in fish is waived, in accordance with Regulation (EC) No.1907/2006, Annexes VIII and IX, Column 2.

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Additional information

According to Regulation (EC) No.1907/2006, Annexes VIII and IX, Column 2, long-term aquatic toxicity testing shall be conducted if the substance is poorly soluble in water, or if the chemical safety assessment indicates the need to investigate further the effects on aquatic organisms. Although the substance has a low water solubility (0.13 mg/L), it is rapidly hydrolysed under environmentally relevant temperature and pH conditions(i.e., at pH 7, DT50= 76 minutes at 15oC and DT50= 35 minutes at 25oC). Each of these hydrolysis half-life values is substantially below the threshold half-life of 12 hours, below which “it can be assumed that the rate of hydrolysis is greater than that for uptake by exposed organisms” (Chapter R.7.c, “Endpoint-specific guidance”, Guidance on information requirements and chemical safety assessment, ECHA, May 2008, Section R., p. 24). The ECHA guidance subsequently states that “in most cases hydrolysis products are more hydrophilic and as a consequence will have a lower potential for bioaccumulation” (Ibid.). The chemical safety assessment indicated that aquatic exposures do not require further investigation; the risk characterisation ratios for surface water are below one. Therefore, in accordance with Annex I, the risks are considered to be controlled, and long-term toxicity testing of fish is not indicated.