Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Two studies are available in order to assess the acute toxicity of the substance to terrestrial macroorganisms on two similar substances of the category of Stilbene Fluorescent Whitening Agents. The two substance are CAS 4193-55-9 and CAS 16470-24-9, the analogous dihydroxyethylamino disulphonated and tetrasulphonated sodium salt, respectively. Specific justifications for Read Across is described within the previous endpoints and within the Justification Category Report attached to the section 13 of the dossier.

The LC50 value in Eisenia foetida was greater than 5000 mg/kg soil dw in a test performed according to OECD 207 for CAS 4193-55-9 (Solvias AG., 1999) and greater than 3000 mg/kg soil dw for CAS 16470-24-9 (Solvias AG., 1999). Both tests were conducted at fixed doses with no effects reported.

Considering that the substance under registration (CAS 13863-31-5) has a lower potential to adsorb to soil than the CAS 16470-24-9 (for further details, see the koc endpoint 5.4.1), the result of its study can be taken as conservative reference.

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 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 negligible exposure is expected.

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