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Long-term toxicity to aquatic invertebrates

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long-term toxicity to aquatic invertebrates
Data waiving:
exposure considerations
Justification for data waiving:
according to guideline
OECD Guideline 211 (Daphnia magna Reproduction Test)

Description of key information

Study not needing according to Column 2 of REACH annex IX: the chemical safety assessment according to Annex I indicates no need to investigate further the effects on aquatic organisms

Key value for chemical safety assessment

Additional information

According to Annex XI par. 3 and to Column 2 of REACH annex IX the test can be omitted based on the result of the chemical safety assessement.

According to the equilibrium partitioning Fugacity model III, the water % is 11.5% , then the water compartment is not the preferred one for the substance.

The water solubility is really low, under 0.026% and the acute tests indicate toxicity values only for very high concentrations. (100.000 mg/L).

The substance has a water primary biodegradation of less than 2 days and a DT50 in fresh water of 5-7 days. A long term test is not justified because of the biodegradation rate in environmental conditions.

A tier 1 Risk Assessment based on the European main use of the substance elaborated with EUSES 2.0 showed no concern; it is assumed that water exposure will not occur because the exposure scenarios is focused only on industrial application where all waste, when present, is sent to STP, where a 100% of degradation occurs. (See annex in the "Long term toxicity to fish" end point summary)