Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
biodegradation in soil: simulation testing
Data waiving:
exposure considerations
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:
JUSTIFICATION FOR DATA WAIVING
In accordance with column 2, section 9.2.1.3 of REACH Annex IX, the study does not need to be conducted if direct and indirect exposure of soil is unlikely. The substance is not directly applied to soil and based on its intended use and handling will not enter the terrestrial environment. The indirect exposure of soil to this substance via sewage sludge is also of no concern based on the treatment of the sludge. 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 the 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