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Long-term toxicity to aquatic invertebrates

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The chronic toxicity of the test substance towards Daphnia magna has been examined in four GLP guideline studies according to OECD 211 [BASF SE 2007, 2009, 2018a, b].

The first study was carried out as semistatic test with 2 - 3 day test medium renewal, however, revealed several shortcomings during the preparation of the test media (i.e. precipitation of iron) which negatively affected the daphnid reproduction in a non-substance related manner (BASF AG 2007). Therefore, the study was considered as not reliable and consequently not appropriate for the hazard evaluation of the substance (RAC decision, 29th November 2018).

The second study was carried out using a flow-through test design up to the test substance solubility limit under test conditions (BASF SE 2009). Since the test substance is sparingly soluble in water, a saturated solution of the test substance in the dilution water was prepared using a saturation column. At test termination after 21 days, an overall NOEC >= 14.3 µg/L was determined.

Two additional confirmatory GLP studies according to OECD 211 on two different strains of daphnids were carried out as semi-static test design with daily renewal (BASF SE 2018a, b). The tes media were prepared from a saturation colum derived stock solution in order to avoid any prepcipitation of iron. Both tests were accired out as limit test at the solubility limit under test conditions and revealed a NOEC of >= 11.4 and 12.7 µg/L (time-weighted mean measured concentration), respectively.

Taking all reliable results into account, the test substance had no observable chronic effects on Daphnia magna up to its saturation limit in the test media and under test conditions.