Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Acutely harmful to aquatic organisms. Depending on local conditions and existing concentrations, disturbances in the biodegradation process of activated sludge are possible.

This aquatic toxicity assessment was based on the following data:

The acute toxicity of the test substance to zebra fish was investigated in a GLP guideline study according to OECD 203. The LC50 after a test duration of 96h (based on analytically verified nominal concentrations) was determined to be 60.03 mg/L (BASF AG 17F0206/965059, 1998). Based on these data the test substance is considered to be acutely harmful to fish.

The acute toxicity of the test substance on Daphnia magna was determined in a GLP guideline study according to EU method C2. The EC50 value was determined to be greater than 100 mg/L (BASF AG 96/0276/50/11, 1997). Therefore, the test substance is considered with high probability acutely not harmful to aquatic invertebrates.

The toxicity of the test substance to green algae was investigated in a GLP guideline study according to OECD 201 (BASF SE 60E0074/12X207, 2013). In this study, the EC10 was determined to be 19.73 mg/L and the EC50 value was determined to be 58.1 mg/L on the growth rate of Pseudokirchnerella subcapitata (analytically verified values). Hence, the test substance considered to be harmful to aquatic algae.

The toxicity to microorganisms was tested in a GLP approach according to OECD guideline 209 using domestic non-adapted activated sludge as inoculum (BASF SE 08G0074/12G233, 2013). After an incubation period of 180 minutes the EC10 was found to be 3 mg/L while the EC50 was estimated to be 64 mg/L, both related to the nominal concentrations. Hence, depending on local conditions and existing concentrations, disturbances in the biodegradation process of activated sludge are possible.

In Annex IX of Regulation (EC) No 1907/2006, it is laid down that long-term toxicity to aquatic organisms shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on aquatic organisms. The results of the risk assessment covering all relevant exposures throughout the life cycle of the submission item demonstrate the absence of a risk to the environment. The environmental concentrations were predicted and compared to the respective PNECs. The resulting RCRs for all identified uses were clearly below 1. Consequently, a need to investigate chronic effects on aquatic organisms is not indicated.