Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

In accordance with Column 2 of REACH, Annexes VIII, if the substance is highly insoluble in water (water solubility: 8.22 µg/L) and considering exposure to the environment is negligible, the short-term studies to aquatics, sediment, soil and microorganisms do not need to be conducted.

Instead besides a freshwater algae toxicity test (OECD 201) was performed, seconded by a long-term toxicity to Daphnia study (reproduction test according to OECD 211) and a fish early life stage study (OECD 210) have been performed.

The long-term daphnia study and the fish early life-stage study were supported by a solubility study for the substance in the respective test media used for these studies (Elendt M4 medium and ISO water) to determine the true maximum solubility of the test substance in these test media, as during performance of the studies precipitation was observed, affecting the study findings.

The growth inhibitions study with algae resulted in no effects on algae growth up to the highest concentration tested (320 µg/L nominal, 127 µg/L actual, determined as sum of dissolved and particulate substance).

The daphnia reproduction study (semi-static) showed effects on reproduction and the NOEC found in this study was 12.8 µg/L nominal / 10.1 µg/L measured as time weighted average. As the determination of true water solubility in Elendt M4 medium used in this study was found being less than 0.512 µg/L, the NOEC was more than a magnitude above the limit of solubility and effects seen were attributable to physical properties of undissolved particulates.

Also, in the fish early life-stage test (flow-through) effects were noticed at high concentrations and the NOEC in this study was set to 2.56 µg/L nominal / 2.25 µg/L measured as arithmetic mean. However, the determination of true water solubility in ISO water, used in this study, was found being at maximum 0.0322 µg/L, and thus, the NOEC was more than two orders of magnitude above the limit of solubility in the test medium and effects seen also in this case were attributable to physical properties of undissolved particulates.

In conclusion, the test substance had no toxic effects on green algae, daphnia and zebrafish in long-term studies performed, when tested at its maximum solubility in test media.