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There are valid acute studies available for three trophic levels for 4,4´-(9H-fluoren-9-ylidene)bis(2-chloroaniline) (CAS No. 107934-68-9). As the substance is poorly soluble, the test item was initially suspended in solubilizer in all acute aquatic ecotoxicity tests. No toxic effects occurred up to the highest test substance concentration for algae and fish. For Daphnia toxic effects were observed at 1.1 mg/L which is well above the substances water solubility (water solubility < 0.052 mg/L in aqua dest.).

In addition to these acute studies a long term test on Daphnia magna (OECD 211) is available for this substance. Due to the low water solubility of the test item, a Water Soluble Fraction (WSF) was prepared at a loading rate of 5.0 mg/L and used as the highest concentration. Lower test concentrations were prepared by diluting the highest concentration in test medium. The actual concentrations measured in the undiluted WSF at the start of each refreshment period were at the level of 1.0 to 2.0 µg/L. Significant reduction of reproduction was found at average measured exposure concentrations of 14 ng/L and higher. 4,4’-(9H-fluoren-9-ylidene)bis(2-chloroaniline) did not affect reproduction of Daphnia magna at 6.8 ng/L after 21 days of exposure (NOEC). Therefore, in contrast to results of acute aquatic ecotoxicity tests, adverse effects are observed within the substances water solubility.

As given in the Guidance on Information Requirements and Chemical Safety Assessment R.11 PBT-assessment (ECHA 2014) a NOEC < 0.01 mg/L triggers the T (toxicity) criterion. As the NOEC for 4,4´-(9H-fluoren-9-ylidene)bis(2-chloroaniline) (CAS No. 107934-68-9) is considerably lower, the substance is regarded as toxic (T).

A further test on the toxicity to activated sludge is available for this substance (OECD 209) with no observed effects at 1000 mg/L (nominal) on respiration.Therefore, the inhibition of the degradation activity of activated sludge is not anticipated when introduced in appropriate low concentrations.

It should be noted, that due to the strictly self-contained use of the substance, environmental exposure is unlikely. The environmental exposure assessment performed for this substance (see CSR attached to IUCLID section 13) shows that indeed the Risk Characterization Ratio (i. e. PEC/PNEC ratio) in the aquatic compartment is < 1 and therefore, under the current exposure conditions, 4,4´-(9H-fluoren-9-ylidene)bis(2-chloroaniline) (CAS No. 107934-68-9) does not pose a risk to aquatic organisms.