Registration Dossier

Environmental fate & pathways

Biodegradation in water and sediment: simulation tests

Administrative data

Endpoint:
biodegradation in water: sediment simulation testing
Data waiving:
exposure considerations
Justification for data waiving:
the study does not need to be conducted because direct and indirect exposure of sediment is unlikely
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with column 2, section 9.2.1.2 of REACH Annex IX, simulation testing on degradation in surface water is waived because the test substance is highly insoluble. In accordance with column 2, section 9.2 and section 9.2.1.4 of REACH Annex IX, sediment simulation 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.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion