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No specific tests on the substance under registration was performed, but the substance is part of the Stilbene Fluorescent Whitening Agents category, group 4, and the most representative analogous substance within the category is CAS 16470-24-9, the dihydroxyethylamino derivative tetrasulphonated sodium salt. The similarity between the two substances has already been addressed in previous summaries and the same argumentations are valid also for terrestrial toxicity. In the specific case of terrestrial toxicity it can be also underlined that CAS 16470-24-9 can be considered a conservative representative.

Two studies are available within the group of most similar substances in order to assess the acute toxicity of the substance to terrestrial macroorganisms. The LC50 value in Eisenia foetida according to OECD 207 was greater than 5000 mg/kg dry weight for CAS 4193-55-9(Solvias AG., 1999)and greater than 3000 mg/kg dry weight for CAS 16470-24-9(Solvias AG., 1999). Within the whole category further two tests are reported, on CAS 41098-56-0 and CAS 16090-02-1 (the diethyl and the morpholino derivatives, respectively) always indicating no toxicity at the highest tested concentration (see Category Justification Report attached to the section 13 of the dossier).

The four substances have very different water solubilities, different Kow and presumably different adsorption potential based on the koc. Despite the differences none of them indicate terrestrial acute toxicity on macroorganisms at the tested concentrations.

Toxicity to soil microorganisms is not expected.

According to the REACH Regulation, Annex IX, Column 2 (specific rules for adaptation from column 1), further soil toxicity testing 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 5 mg/Kg soil dw, while the maximum monitored reported level of a member of the Stilbene Fluorescent Whitening Agent is of 0.45 mg/Kg[1]. This monitored quantity has been 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).