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Two studies are available in order to assess the acute toxicity of the substance to terrestrial macroorganisms. The EC50 value in Eisenia foetida recorded according to the OECD 207 was greater than 1000 mg/kg dry weight (Ciba-Geigy Ltd., 1991). The result was substantiated by a limit test that determined a LC50 value greater than 5000 mg/kg dry weight (Solvias AG., 1999). No concern for soil toxicity is then arisen by the presented acute studies.

According to the REACH Regulation, Annex IX, Column 2 (specific rules for adaptation from Column 1), a further soil toxicity test is not proposed by the registrant because the Chemical Safety Assessment, according to Annex I, does not indicate the need to investigate further the effects on soil organisms.

In order to limit the hazardous for soil compartment, the risk assessment for the substances belonging to the category has been performed using the highest experimental Koc value. In this way, the Predicted Environmental Concentrations in soil are maximized (for further details, see the Category Justification Report).

The PNEC soil calculated based on the result of acute toxicity test is of 1 mg/Kg soil dw, while the maximum monitored level reported is of 0.45 mg/Kg [1]. This monitored quantity was measured after voluntary exposure of the soil to the sludge, while the exposure scenario is reporting that sludge is usually incinerated and not spread on the agricultural soil. Based on the Chemical Safety Assessment and the described exposure scenarios no exposure is expected.

[1]HERA Report 2004: Substance: Fluorescent Brightener FWA-1 (CAS 16090-02-1).