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Toxicity to soil macroorganisms except arthropods

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toxicity to soil macroorganisms except arthropods: short-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

Description of key information

Toxicity testing in soil macro-organisms is waived, in accordance with Regulation (EC) No.1907/2006, Annex IX, Column 2.

Key value for chemical safety assessment

Additional information

According to Regulation (EC) No.1907/2006, Annex IX, Column 2, toxicity testing on terrestrial organisms need not be conducted if direct and indirect exposure of the soil compartment is unlikely. The substance does not have a high potential to adsorb to soil, based upon the experimentally-determined adsorption coefficient (Koc) of 825 L/kg (i.e., log Koc= 2.916) for tetrapropenyl succinic anhydride, by read-across based on a grouping of substances (category approach). The log Koc= 2.916 is substantially below the criterion that is indicative of strong binding to soil (i.e., log Koc> 4, in accordance with ECHA,Chapter R.7.a, “Endpoint-specific guidance”, Guidance on information requirements and chemical safety assessment, May 2008, Section R.7.1.15, p. 154). The hazard associated with exposures of the substance to terrestrial organisms was evaluated in the chemical safety assessment on the basis of a predicted no-effects level calculated from aquatic toxicity levels and equilibrium partitioning. The chemical safety assessment indicated that terrestrial exposures do not require further investigation; the risk characterisation ratios for soil are below one. Therefore, in accordance with Annex I, the risks are considered to be controlled, and direct and indirect exposures of terrestrial organisms to the soil are unlikely. Therefore, toxicity testing on soil macro-organisms is not indicated.