Registration Dossier

Environmental fate & pathways

Biodegradation in soil

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
biodegradation in soil: simulation testing
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, a simulation test in soil need not be conducted. There is no direct exposure to soil and the chemical safety assessment according to Annex I shows that the risk characterisation at the regional scale demonstrated safe use for indirect exposure to soil. Thus no refinement of the estimated soil half-life and PECregional 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).