Registration Dossier

Administrative data

Endpoint:
toxicity to soil microorganisms
Data waiving:
exposure considerations
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with section 3 of REACH Annex XI the study Toxicity to soil microorganisms (section 9.4.2) does not need to be conducted.
A PNECsoil could be derived based on the Equilibrium Partitioning Method (EPM) and comparing this PNEC with the results of the exposure assessment reveals RCRs for soil organisms below 1 in the CSA. For this substance the EPM is considered sufficient, as the substance is not classified as hazardous for the environment, as the substance does not have a high potential for adsorption (logKoc is 3.28) and as the substance is readily biodegradable.
In addition, an 3h-EC50 value of >1000 mg/L was determined for the inhibitory effect of the substance on activated sludge bacteria in a study performed in accordance with OECD 209.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion