Registration Dossier

Administrative data

Endpoint:
toxicity to terrestrial plants: short-term
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
a short-term study does not need to be conducted because an appropriate long-term toxicity study on terrestrial organisms is available
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
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