Resin acids and Rosin acids, maleated, esters with pentaerythritol

Biodegradation in soil

Description of key information

The rosin adduct ester category consists of fumarated and maleated esters of glycerol and pentaerythritol. The substances consist of ester constituents (mono-, di- and tri- glycerol esters and mono-, di-, tri- and tetra- pentaerythritol esters), and free resin acids. Standard biodegradation studies are not really appropriate for whole substance UVCBs and therefore as much is reasonably practicable, biodegradation of the individual consituents as a whole needs to be considered. In order to prioritise the consituents that may require further testing a PBT screening assessment of Rosin Adducts and Rosin Adducts Salts substances was undertaken. The logic being that if a consituent is both Persistent and Bioaccumulative then further testing on these constituents would be required.

Guidance for mono-constituents is available from ECHA; however, for complex substances such as Unknown or Variable Composition, Complex reaction products or Biological materials (UVCBs) there is currently little guidance on how the PBT/vPvB assessment should be conducted. A pragmatic approach for UVCBs is to evaluate all the individual constituents present in the substance at a concentration of ≥0.1% for their PBT properties.

As this is a UVCB substance it is not possible to identify every single constituent at a concentration of 0.1% (which numbers thousands)and detailed analysis of each individual constituent within the substance is not available. As such, a list of representative constituents has been developed from information in the Substance Identity Profiles. All identified representative constituents were assessed individually for their P and B properties.

Any constituents that are both P and B will be taken forward for further simulation studies.

Following the Screening assessment detailed above the data gathered suggests that whilst conclusions on Persistence cannot be drawn for the constituents where data are from QSARs alone, none of the constituents are expected to be Bioaccumulative. Five of the constituents were found to be not P based on experimental data these correspond to 4 of the constiuents that were identified as being potentially B/vB, these are therefore not considered PBT or PvB. It is noted that, even if the data on bioaccumulation is exclusively from QSARs for this substance, the models used are reliable, well documented and well known and fit these types of constituents, even those substances that have a higher Kow than the training data set. The Predicted BCF values in both models were much lower than the 2000 L/kg criterion for B in the Regulation and therefore there is high confidence that there are no constituents of concern in this substance. Therefore, no simulation studies are required on any constituents in this substance.