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Ecotoxicological information

Long-term toxicity to fish

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Description of key information

Waiving

Key value for chemical safety assessment

Additional information

Direct and indirect exposure is unlikely due to the risk management measures that will be applied at industrial level and discussed in details within the exposure scenario to avoid any release of the substance directly in the municipal waste water treatment.

The monitoring data and the field studies (reported into the IUCLID section 5) showed that the substance can be effectively removed from the waste waters, because of the affinity with the organic fraction. Therefore it is expected that the discharge in environment will be very low.

Based on both the acute and the long term tests a PNEC of 0.13 mg/l in freshwater is calculated, while the maximum exposure estimated by EUSES, on the basis of the actual exposure scenarios and conditions of use are of 0.0075 mg/l, as well as the maximum monitored quantity referred to 1997. Furthermore the local RCR in surface water is 0.04 and 0.0052 based on estimated and monitored quantities.

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 resulted to be controlled using the same risk management measures (for further details, see the category justification document).

Another aspect that can be taken into account is that a test (with a good reliability) on the toxicity to fish at 14 -days with Brachydanio rerio is available. The nominal concentrations of 100, 316, 1000 mg /l were tested and a NOEC was identified at the concentration of 61.8 mg/l (measured); the Lowest Observed Effect Concentration (LOEC) was 316 mg/l (nominal).

Taking into account these further results and the expected concentrations in environment, a long term toxicity test on fish is deemed as unjustified.