[No public or meaningful name is available]

Biodegradation in water and sediment: simulation tests

Administrative data

Endpoint:

biodegradation in water: simulation testing on ultimate degradation in surface water

Remarks:

Including Identification of degradation products

Type of information:

experimental study planned

Remarks:

Experimental study is ongoing. Please see "Justification for type of information" and attached documents for further details.

Justification for type of information:

The registered substance has a log Kow of 1.6 and a water solubility of 4 g/L. It is hydrolytically rather stable with half-lifes > 1 year at pH 4 and 7, while short with 15 d at pH 9. Photo-transformation in air is short with 0.4 days. Ready biodegradation was observed and determined as 50 % after 28 days in an OECD 301F study, while inherent biodegradation was determined to be 73 % after 28 days in an OECD 302C study.
In the relevant tonnage band there is the requirement to conduct a simulation study for degradation in water, which basically applies in this case based on the log Kow, water solubility and biodegradation data.
The wainving options do not (clearly) apply:
a) highly insoluble in water: Does not apply, as the substance is well soluble in.
b) ready biodegradability: The substance is certainly not persistent but the criterion for ready biodegradability was not fulfilled.
c) Direct and indirect exposure unlikely: There is no data to allow a conclusion on this criterion. As the substance is not classified for environmental hazards there is no need to provide a CSR and, therefore, it may not be demonstrated that the potential for direct or indirect emissions is low, although this is expected based on the uses of the substance (e.g., industrial indoor uses).
Moreover, it should be considered that the substance is not classified for environmental hazards. There were no effects in the environment as no toxicity was observed up to the highest test concentrations in each study. Thus, the PNECs were derived using the EC/LC0 only (or the EPM method).
The available data, thus, underlines that the substance is not toxic or persistent in the environment. Based on the uses it is rather unlikely that direct or indirect emission to environment occur (even if there is no such data).

The ECHA has given a final decision to the registrant (DEV-01-2119488927-15-0000-TPE-1_DEC_REG_TPE) and proposed the study to be conducted.

The simulation testing on ultimate degradation in surface water as well as the identification of degradation products are currently ongoing. The radiosynthesis of the substance was completed in February 2023 at Eurofins-Selcia Ltd. The study for biodegrdation simulation and identification of degradation products has commenced at Fraunhofer Institute for Molecular Biology and Applied Ecology. Based on the timelines, the final report is expected to be available in December 2023 and the IUCLID dossier would be updated immediately afterwards. Please see attachments for further justification.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 309 (Aerobic Mineralisation in Surface Water - Simulation Biodegradation Test)

Test material

Test material information

Constituent 1

Reference substance name:

2-benzofuran-1,3-dione, addition product with 2-(2-hydroxyethoxy)ethanol, ethoxylated

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

2-benzofuran-1,3-dione, addition product with 2-(2-hydroxyethoxy)ethanol, ethoxylated

Test material form:

liquid

Details on test material:

Clear colourless viscous liquid