Registration Dossier

Environmental fate & pathways

Biodegradation in water and sediment: simulation tests

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Link to relevant study record(s)

Description of key information

In accordance with column 2, section 9.2  and section 9.2.1.4 of REACH Annex IX, further biotic degradation testing is waived.  The Chemical Safety Assessment indicates the direct and indirect exposure of sediment is unlikely.  ECHA Chapter R.7B and R.7C guidance states that if the PEC/PNEC ratio is below 1, then no risk for the compartment is indicated, that the information available may be sufficient to conclude the assessment, and there is no need to perform further tests.  Additionally, ECHA Chapter R.7B guidance states that if the substance is not considered a PBT or vPvB candidate, then it is considered not necessary to conduct further testing on the compartment.   Therefore, on the basis of a lack of potential exposure and low risk demonstrated by RCRs of less than 1 based on EUSES modelling, waiving is justified.

Key value for chemical safety assessment

Additional information

The UVCB substance is poorly biodegradable in water. Comparable degradation rates are expected for biodegradation in surface water and sediment.