Registration Dossier

Environmental fate & pathways

Biodegradation in water and sediment: simulation tests

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

Biodegradation testing in water and sediment are waived, in accordance with Regulation (EC) No.1907/2006, Column 2 of Annex IX, as the substance has been shown to be rapidly biodegradable in a soil aerobic degradation study.  

Key value for chemical safety assessment

Additional information

According to Regulation (EC) No.1907/2006, Annex IX, Column 2, biodegradation testing in surface water and sediment need not be conducted if the substance is readily biodegradable. A soil simulation biodegradation study showed that the substance was rapidly biodegradable in soil under aerobic conditions; the soils were not pre-adapted to the substance, which was applied at a concentration of 0.376 mg/kg soil dry weight. Mineralisation was reported at 70.7% in 28 days, and at 80.8% in 121 days (at the conclusion of the test). The DT50 for the substance (i.e., the parent compound) and its primary metabolite (i.e., Metabolite II) were reported as 9.7 days and 3.5 days, respectively, each based on the Single First Order Model. Therefore, the substance has been shown to be rapidly biodegradable under aerobic conditions. The experimentally-determined rapid degradation in soil is sufficient documentation for showing rapid degradation in surface water and sediment, in accordance with ECHA guidance (Guidance on the application of the CLP criteria, Version 3.0, November 2012, Section II.2.3.6, p. 498).