Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

In accordance with REACH Annex IX, Section 9.4., column 2 the experiments for soil macroorganisms, terrestrial arthropods and plants as well as for soil microorganisms does not need to be conducted since direct and indirect exposure of the soil compartment is unlikely.

In addition to that,the Endpoint Specific Guidance of ECHA (2008, Chapter R.7C, p 120) clarifies: “When soil exposure is considered negligible, i.e. where there is low likelihood of land spreading of sewage sludge, or aerial deposition of the substance and other pathways such as irrigation or contact with contaminated waste are equally unlikely, then neither a PEC, nor PNEC can or need be calculated and no soil toxicity data are necessary.” The CSA clearly suggests that the PEC/PNECscreen ratio will be irrelevantly low. Therefore no relevant exposure of soil macroorganisms to the submission item is expected and testing for effects is deemed not necessary.

No information regarding toxicity to birds and other above-ground organisms needs to be provided for REACH Registration of a tonnage band of 100 - 1000 tons/year. The Predicted No Effect Concentration (PNEC) for soil was derived from the PNECfreshwater using the equilibrium partitioning method.