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Sediment toxicity

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sediment toxicity: long-term
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study scientifically not necessary / other information available
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In Annex X of Regulation (EC) No 1907/2006, it is laid down that long-term toxicity testing on sediment organisms shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the toxicity of chemical substances on this compartment. According to Figure R7.8-9 "Integrated testing strategy (ITS) for toxicity to sediment organisms" (p.157) from Guidance on information requirements and chemical safety assessment, chapter R7b (v4.0 ; June 2017), sediment risk assessment is necessary when log kow of the substance is higher than 3, which is the case of BPA (1-4.5 EO). In accordance with this ITS, the EPM method was applied for risk assessment of the sediment compartment. Risk assessment demonstrated that there is no risk for sediment organisms using the PNEC derived through equilibrium partitioning method. Therefore, the chemical safety assessment indicates no need for toxicity testing on sediment organisms. Thus, no testing is proposed, in compliance with Annex X of Regulation (EC) No 1907/2006.

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