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Environmental fate & pathways

Biodegradation in water and sediment: simulation tests

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Simulation testing in surface water:

Waiving in accordance with Regulation (EC) No 1907/2006, Annex IX, Section, Column 2

According to Regulation (EC) 1907/2006, Annex IX, Section, Column 2, a simulation study on ultimate degradation in surface water does not need to be conducted if the substance is highly insoluble in water. The substance is not soluble in water (WS < 0.03 mg/L; BASF SE, 2011, Report no.: 10L00315; see IUCLID Ch. 4.8). Therefore, no biodegradation studies in surface water will be provided.


Simulation testing in sediment:

Waiving in accordance with Regulation (EC) No 1907/2006, Annex XI, Section 1.3

The substance is not readily biodegradable according to two guideline studies (1: BASF AG, 1986; Report no. 286015; EU method C.4-D; 2: BASF (China) Company Ltd, 2011; Report no. R1101250238C; OECD TG 301F). The study by BASF AG (1986) was run for an extended test period of 56 d; however, the biodegradability did not exceed 16%. In just two of 7 replicates a low percentage of degradation was observed, while none was observed in the other replicates. Therefore, it is expected that the substance is not biodegraded through growth linked processes. As the conditions for biodegradation in the requested simulation study is less favorable compared to the ready biodegradability tests, the substance will most likely persist in the study with no formation of degradation products.

In accordance with Regulation (EC) No 1907/2006, Annex XI, Section 1.3, it is concluded to assess potentially forming degradation products using QSAR models for predicting their composition, quantity, biodegradability, and bioaccumulation potential. Please refer to IUCLID Ch. 5.2.1 and 5.3.1.

Therefore, a sediment simulation test is not provided.