Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

In accordance with Annex IX, column 2, 9.4 or Regulation (EC) No 1907/2006, effects on terrestrial organisms do not need to be investigated since a direct and indirect exposure of the soil compartment is unlikely. A direct exposure of the soil compartment is negligible based on the identified uses (refer to IUCLID Section 3.5). The uses include industrial uses (defined by ERC2) for which the direct exposure to agricultural soil can be excluded since it is assumed that soil at industrial plants is sealed. Soil exposure by wide-dispersive use (defined by ERC 8a) is unlikely. The use of applicable spERCs (COLIPA SPERC 8a.1.a.v1, 8a.1.b.v1 and 8a.1.c.v1) exclude exposure to soil based on a release rate of 0% to agricultural soil. An indirect exposure to the land via activated sludge application from exposed STPs is unlikely because the substance is readily biodegradable. Moreover application via irrigation is negligible since the substance is not used in products intended to be used in agriculture and has low water solubility (< 0.05 mg/L). Taking all these information into account it can be assumed that direct and indirect exposure of the soil compartment is unlikely and no testing on terrestrial organisms is deemed necessary.

Testing for avian toxicity is not required because a risk for secondary poisoning is negligible (The substance is readily biodegradable, has a low potential for bioaccumulation and moreover there is no evidence of toxicity in mammalian repeat dose or reproduction tests).