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Toxicity to terrestrial plants

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In Annex XI Section 3, it is laid down that testing in accordance with sections 8.6 and 8.7 of Annex VIII and in accordance with Annex IX may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report (“Substance-Tailored Exposure-Driven Testing”). In accordance with Annex XI Section 3, it can be demonstrated in the risk assessment that the manufacture and the use of the substance do not pose an unacceptable risk for all environmental compartments as the risk characterization ratios (RCRs) of the chemical safety assessment are clearly below 1 for all compartments (see Chemical Safety Report Ch. 9, 10).


Furthermore, the test substance is not supposed to be directly applied to soil and an indirect exposure to soil via sewage sludge transfer is unlikely since the substance is readily biodegradable. For a substance being considered as „readily biodegradable“, it can be assumed that it will be biodegraded within the STP process and as a consequence a transfer to the soil compartment is not expected.


Consequently, no tests on terrestrial plants are performed. The equilibrium partitioning method has been used for assessing the hazard to terrestrial organisms in accordance with Annex IX, Section 9.4, Column 2 of Regulation (EC) No 1907/2006.