Registration Dossier

Environmental fate & pathways

Biodegradation in soil

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Description of key information

Study WAIVED - 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 RCRs of less than 1 based on EUSES modelling, waiving is justified.

Key value for chemical safety assessment

Additional information

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 RCRs of less than 1 based on EUSES modelling, waiving is justified.