Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no data: aquatic toxicity unlikely

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

In acute aquatic studies on organisms like fish, daphnia and algae no effects have been observed up to the limit of the water solubility. The substance is “not biodegradable” and also not “not inherently biodegradable”. The log Kow is >3,0 and it is poorly water soluble (<0.05 mg/L)..

For these reasons, the substance is currently legally classified as R53 (Directive 67/548/EEC) or chronic category 4, H413 (safety net classification) (Regulation EC 1208/2008).

However, additional scientific evidence has been elaborated by a new chronic study in daphnia performed in 2014 which shows no effects up to the limit of the water solubility (NOEC >0.024 mg/L). Further evidence is given by the BMF study which showed no bioaccumulation potential. For these reasons the classification chronic category 4 (H413) is considered to be unnecessary which is already reflected in the self-classification. To this end, the Registrant intends to start the process with the MSCA in order to omit the legal classification chronic category 4 (H413) as no classification for the environment is applicable based on above testing data.

As a consequence of above studies and the intended non-classification conducting an environmental risk assessment is not considered appropriate or necessary.