Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

In Annex IX of Regulation (EC) No 1907/2006, it is laid down that long-term toxicity testing shall be proposed by the registrant if the results of the chemical safety assessment according to Annex I indicates the need to investigate further the effects of the substance and/or degradation products on terrestrial organisms. It is also stated that these studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely. 

There are no defined uses where direct exposure of this substance to the soil compartment is likely. Also, as this substance is readily biodegradable, it can be assumed that it will be biodegraded within the STP process and as a consequence indirect transfer to the soil compartment from sludge is not expected. Furthermore, the results from an earthworm study have been used to assess the hazard to terrestrial organisms and further investigation of the effects of the substance and/or its breakdown products on terrestrial organisms is not justified and are waived.

Toxicity to soil macroorganisms except arthropods

An acute toxicity study to earthworms was conducted to determine the effect of the test material DEGDB on earthworms (HLS 1998, VCL271/972157). The study was conducted according to OECD and EU test guidelines, and in compliance with GLP. Groups of earthworms were exposed to DEGDB at levels of 0 (control), 95, 171, 309, 556, and 1000 ppm (mg/kg) in an artificial standard soil, for a test period of 14 days. Each treatment and control group consisted of four replicate containers, each with ten worms per container (forty worms per group, total).

No mortalities were seen during the study, and all worms were normal in appearance on days 7 and 14 of the test.

The LC50 value of DEGDB to the earthworm was found to be in excess of 1000 ppm. The no-observed effect level (NOEL) was considered to be 1000 ppm.


Toxicity to terrestrial arthropods

This test is proposed to be waived.

Toxicity to terrestrial plants

This test is proposed to be waived.

Toxicity to soil microorganisms

This test is proposed to be waived.

Toxicity to birds

This test is proposed to be waived.

Toxicity to other above-ground organisms

No data available. No data required.