Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

DEGDB:

- Key study, reliability 1, OECD 207, Eisenia fetida - LC50 (14 d) > 1000 ppm; NOEC (14d) = 1000 ppm

DPGDB:

- Key study, reliability 1, OECD 207, Eisenia fetida - LC50 (14 d) > 1000 ppm; NOEC (14d) = 1000 ppm

TEGDB:

- Key study, reliability 1, OECD 207, Eisenia fetida - LC50 (14 d) > 1000 ppm; NOEC (14d) = 1000 ppm

Additional information

This substance is a reaction mass of dipropylene glycol dibenzoate (DPGDB), diethylene glycol dibenzoate (DEGDB) and triethylene glycol dibenzoate (TEGDB). No testing has been performed on the reaction mass itself but data are available for DPGDB, DEGDB and TEGDB.

Acute toxicity to earthworms studies demonstrate that the three components have similar toxicity, with LC50 values all in excess of 1000 ppm (mg/kg).

 

The studies were performed according to international test guidelines and in compliance with GLP. The studies were carried out in artificial soil. No mortalities were seen during the studies, (DPGDB: HLS 1998, VCL 259/972156, DEGDB:HLS 1998, VCL271/972157, TEGDB: HLS 1998, VCL294/972158) and all worms were normal in appearance on days 7 and 14 of the tests. Under the conditions of these studies, the LC50 values to the earthworm were found to be in excess of 1000 ppm. The “no-observed effect level” (NOEL) was considered to be 1000 ppm in each case.

 

The key value used in the chemical safety assessment is: 1000 ppm (1 mg/kg soil dw)

OTHER ENDPOINTS

 

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 earthworm studies on the three components have been used to assess the hazard to terrestrial organisms. Further investigation of the effects of the substance, and/or any of its components or its breakdown products on additional terrestrial organisms is not justified and are waived.

 

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.