Registration Dossier

Environmental fate & pathways

Biodegradation in water and sediment: simulation tests

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Description of key information

The study will not be conducted based on REACH guidance for waiver.

Key value for chemical safety assessment

Additional information

The supported uses for this substance are limited to industrial closed systems and as such are not expected to lead to direct or indirect exposure to the environment. Therefore the test is not required based on REACH guidance.

However, under unlikely circumstances of accidental release of the test substance (e.g., unplanned event of loss of containment), soil compartment would be the most likely receiving environmental media. According to Column 2 of REACH Annex IX (“9.2. Further biotic degradation testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the degradation of the substance and its degradation products. The choice of the appropriate test(s) depends on the results of the chemical safety assessment and may include simulation testing in appropriate media (e.g. water, sediment or soil).”), soil compartment is the most likely environmental media for receiving potential accidental release. Therefore, aerobic mineralisation in surface water – simulation biodegradation test (test method: EU C.25./OECD 309) and sediment degradation testing (OECD 308) are justified to be waived. In addition, the OECD 307 soil simulation test is likely to provide more accurate information about the biodegradability of the substance than the OECD 308 test, which is prone to significant experimental issues (M. Honti and K. Fenner, Environ. Sci. Technol. 2015, 49, 5879−5886).