Registration Dossier

Administrative data

Endpoint:
toxicity to terrestrial arthropods: long-term
Data waiving:
exposure considerations
Justification for data waiving:
the study does not need to be conducted because direct and indirect exposure of the soil compartment is unlikely
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
This substance is not directly applied to soil and based on its intended use will not enter the terrestrial environment and therefore no testing of terrestiral organisms is required. The indirect exposure of soil to this substance via sewage sludge is also of no concern based on the treatment of the sludge. In accordance with section 9.4 of REACH Annex IX and X, further tests do not need to be conducted if direct and indirect exposure of the terrestrial compartment is unlikely. The substance is not directly applied to soil and based on its intended use and handling will not enter the terrestrial environment. ECHA Chapter R.7B and R.7C guidance states that if the PEC/PNEC ratio is below 1, then no risk for the compartment is indicated, that the information available may be sufficient to conclude the assessment, and there is no need to perform further tests. In addition, ECHA Chapter R.7B guidance states that if the substance is not considered a PBT or vPvB candidate, then it is considered not necessary to conduct further testing on the compartment. Therefore, on the basis of a lack of potential exposure, and hence risk, and low risk demonstrated by the RCRs less than 1 based on EUSES modelling, it is considered that the information available is sufficient and further testing is not required. If necessary, data available from aquatic toxicity testing can be used as a worst case scenario if further characterization of the terrestrial compartment is desired.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion