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Environmental fate & pathways

Biodegradation in water and sediment: simulation tests

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Endpoint:
biodegradation in water: sediment simulation testing
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Transformation products:
no
Endpoint:
biodegradation in water: simulation testing on ultimate degradation in surface water
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Transformation products:
no

Description of key information

Key value for chemical safety assessment

Additional information

In accordance with REACH Annex IX column 2, simulation tests in water and sediment need not be conducted as the chemical safety assessment according to Annex I does not indicate the need to investigate further the degradation of the substance and its degradation products. The risk characterisation at the regional scale demonstrated safe use for both the water and sediment compartments and no further refinement of the estimated water and sediment half-life is needed. Furthermore the substance is considered to be inherently and ultimately biodegradable and not persistent. The registrant also considers that there is no need to identify degradation products in order to assess their potential PBT/vPvB properties based on high levels of % BOD in 3 extended ready biodegradation tests (indicating any transient metabolites are further degraded), chemical specific analysis which showed parent and target metabolites were below the limit of detection at the end of a screening test, and the use of biodegradation models that showed any predicted metabolites present at >0.1% at the end of a screening test were not B i.e. log Kow < 4.5 (see IUCLID endpoint summary 5.2.1 and CSR section 4.1.2.1.3 for details).