Registration Dossier

Diss Factsheets

Ecotoxicological information

Toxicity to soil macroorganisms except arthropods

Administrative data

Endpoint:
toxicity to soil macroorganisms except arthropods: long-term
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
According to REACH Annex X Section 9.4.1 Column 2 this study does not need to be conducted if direct and indirect exposure of the soil compartment is unlikely. In the absence of toxicity data for soil organisms, the equilibrium partitioning method may be applied to assess the hazard to soil organisms. Indirect exposure of the soil compartment is possible via deposition of sewage sludge and hence the requirement for testing has to be considered. The PNECsoil was derived from the aquatic toxicity data using the equilibrium partitioning method. Using this PNEC, the RCR for all stages of the lifecycle of the substance were found to be <1, indicating that the risk to invertebrates (excluding arthropods) is adequately controlled and there is no need for further refinement of the assessment through testing.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion