Registration Dossier

Administrative data

Endpoint:
toxicity to soil microorganisms
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
Based on the respiration inhibition test, the registered substance had no inhibitory effect on the respiration rate of activated sludge, after the incubation period of 3 hours at the maximum test item concentration tested of 100 mg/L. Furthermore, in the key biodegradation study, the substance was not toxic tothe sewage treatment micro-organisms at 100 mg/L. Therefore, no toxicity is expected to soil micro-organisms and a study is deemed scientifically unjustified.
In addition, the registered substance is classed as a soil hazard category 3. Therefore, in the context of an integrated testing strategy for soil toxicity, an initial screening assessment based upon the Equilibrium Partitioning Method (EPM) is performed, together with a confirmatory long-term soil toxicity test (e.g. one limit test with the most sensitive organism group as indicated from aquatic toxicity data). The choice of test (invertebrate / plant / micro-organism) should be based on all the information available. For the registered substance, the most sensitive organism group in aquatic toxicity data is the aquatic invertebrates. Therefore, an invertebrate assay is chosen to assess the long-term soil toxicity. Hence, a testing proposal is included in the dossier to conduct an earthworm reproduction test, according to OECD Guideline 222.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion