Registration Dossier

Ecotoxicological information

Toxicity to soil macroorganisms except arthropods

Administrative data

Endpoint:
toxicity to soil macroorganisms except arthropods: long-term
Type of information:
experimental study planned
Study period:
After validation by ECHA
Justification for type of information:
TESTING PROPOSAL
According to section R.7.11.5.3., Chapter R.7c of the ECHA Guidance on information requirements and chemical safety assessment (version 3.0, June 2017), the registered substance should be classed as a soil hazard category 3 (high adsorption of the substance in soil with log Kow > 5 and Koc > 5000; and not very toxic to aquatic organisms).
In the context of an integrated testing strategy for soil toxicity, the Guidance advocates performing an initial screening assessment based upon the Equilibrium Partitioning Method (EPM), 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). Indeed, for substances that show a high potential to partition to soil, like the registered substance, long-term exposure of terrestrial organisms is possible and should be assessed. 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. A simplified study with a limit test is proposed in a first step, as suggested in the ECHA Guidance, to confirm the absence of risk for soil organisms observed in the screening assessment.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Results and discussion

Applicant's summary and conclusion