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Ecotoxicological information

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A study is available on the similar substance CAS 4193-55-9, 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 (Solvias AG., 1999). The reliability is low because just the summary is actually available.

Nevertheless the study is supported by the test on the similar substance of the Stilbene Fluorescent Whitening Agents: the analogous dihydroxyethyl derivative tetrasulphonated sodium salt CAS 16470-24-9, for which also a summary for the same test is available (Solvias AG., 1999). The category Justification Report is attached to the section 13.

No concern for soil toxicity is then arisen by the presented acute studies.

According to 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.

The PNEC soil calculated based on the result of acute toxicity test is of 3 mg/Kg soil dw, while the maximum monitored reported level of a member of the Stilbene Fluorescent Whitening Agents 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.

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).

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