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Sediment toxicity

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Description of key information

waiving

Key value for chemical safety assessment

Additional information

According to the REACH Regulation, Annex IX, Column 2 (specific rules for adaptation from Column 1), sediment 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 effects on sediments.

Koc studies indicate that the substance is capable to form chemical interaction with organic matter; exactly this property is exploited by industries to remove the substance from the waste water within the plants and send the sludge to incineration. A number of studies on STP and sludge can confirm that removal is effective (IUCLID section 5.5). As described in the Chemical Safety Assessment, the domestic use of the substance in detergent formulations is the only scenario where releases interest municipal STPs: concentrations and quantities involved in this use are negligible and below the level of risk calculated with the Equilibrium Partitioning method.

Concentrations and quantities involved in this use are negligible and below the level of risk calculated with the Equilibrium Partitioning method.

Calculated PNEC based on the measured log Koc of 4 is 28.37 mg/Kg sediment ww (130.5 mg/kg sediment dw). The predicted highest conservative value is around 11.6 mg/l, with a local RCR of 0.09 (see Chemical Safety Assessment), while the monitored quantity according to Stoll 1997 is of maximum 0.5 mg/Kg sediment [1].

In order to follow a precautionary approach, the substances manufactured at the highest tonnages in the category have been investigated maximising the water and sediment releases (performing the calculation using the lowest experimental Koc value). Despite the water and sediment PECs result inevitably increased, the risk can be considered controlled using the same risk management measures (for further details, see the Category Justification Report).

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