Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Additional information

The test substance was not readily degradable in a screening non-GLP test with OECD Guideline 301 D (Ready Biodegradability: Closed Bottle Test). In addition, the test substance was not inhibitory at 2.3 mg/L nominal concentration to microorganisms. The result is considered as valid with restrictions (Klimisch 2), and selected as the key study.

It needs to be noted that the 2.3 mg/L nominal concentration highly exceeds the determined water solubility of the test substance.

The form of the test material in the solution may have varied (dissolved, suspended, emulsified). However, in principle the OECD 301D method is suitable for poorly water soluble, volatile and adsorptive substances.

There is also weight of evidence of rapid degradation.The test substance was estimated to be readily biodegradable by BIOWIN 4.10 QSAR modelling. The result of the QSAR modelling is considered as valid, and is rated as reliable with restrictions (Klimisch 2) and used as weight of evidence for classification and labelling and PBT assessment.

The STPWIN fugacity-based QSAR Level III model estimated the test substance to biodegrade 78.15 % in a conventional wastewater treatment plant that uses activated sludge secondary treatment. The estimate for total removal % was 99.99 % (recommended maximum 95 %). The modelling result can be considered as reliable with restrictions (Klimisch 2), as the model may overpredict biodegradability of structurally analogous compounds when using the BIOWIN output and EPA Draft Method option.

In conclusion, bis(2 -ethylhexyl)citraconate is assessed as not readily biodegradable for classification and labelling based on a screening non-GLP OECD 301 D Test. In addition, the substance was observed not to inhibit growth of micro-organisms at 2.3 mg/L nominal concentration. The available QSAR models however provide some weight of evidence of ultimate biodegradability, for which no valid experimental test result is available. The BIOWIN model is however assessed to overpredict biodegradability of structurally analogous compounds.