Registration Dossier

Administrative data

biodegradation in soil: simulation testing
Data waiving:
other justification
Justification for data waiving:
the study does not need to be conducted because direct and indirect exposure of soil is unlikely
Justification for type of information:
According to REACH Annex IX, column 2 adaptation for (simulation testing on ultimate degradation in surface water) the study does not need to be conducted if: - the substance is highly insoluble in water. In a water solubility study the substance was found to have low solubility (0.75 mg/l at 25°C). In ecotoxicity studies conducted the substance was also found to be poorly soluble and also to degrade over the study period (considered to be due in part to hydrolysis). It is therefore considered that simulation testing on ultimate degradation in surface water is not required. The conducted exposure scenarios and risk characterisations for manufacture, formualtion and end use processes (see CSR) resulted in RCRs of <1 for the sediment compartment, indicating that the risk to the sediment compartment is controlled. Therefore it is considered that no further sediment simulation testing is required.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion