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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

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.. The PBT assessment of rosin adduct ester substances therefore considers the PBT potential of each of the constituents, rather than the substance as a whole. The constituents of each substance within Category 4 are expected to be similar and thereforea single PBT assessment covering all of the constituents in this category is justified.

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 of0.1% for their PBT properties.

The previous PBT assessments submitted for this Category have been updatedAs part of this update, all of the blocks of constituents listed in the Substance Identity Profile for substances in this category have been included and at least 1 representative structure has been identified for each block. The previous QSARs have also been re-run to ensure they are up to date and valid. Detailed analysis of each individual constituent within the category is not available and so a list of constituents thought to be present has been developed from information in the Substance Identity Profiles for each substance. All identified constituents were assessed individually for their PBT properties.

There is little data available on the individual constituents found in substances in this category. As such a block approach has been applied using data from the Substance Identity Profile. Constituents that are thought to be present in each block were identified and used to assess if the blocks are potentially PBT/vPvB.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. Therefore, non-reacted rosin acids, fatty acids and neutrals remain as constituents in the UVCB. Representative constituents have been assigned to the latter two blocks based on the H4R consortium’s knowledge of the composition of the parent Rosin, and Resin Acids and Rosin Acids and their salts.

 The blocks and their representative constituents that were assessed are listed in Table1.

Table 1 Blocks present in this category and representative structures for each block.

Block

Constituent

 

 

Total Esters (Rosin acids + Poly esters)

Rosin adduct, mono-Glycerol

Rosin adduct, di- Glycerol

Rosin adduct, tri- Glycerol

Rosin adduct, mono-Pentaerythritol

Rosin adduct, di- Pentaerythritol

Rosin adduct, tri- Pentaerythritol

Rosin adduct, tetra- Pentaerythritol

Rosin adduct, tri- Glycerol

Rosin adduct, tri- Pentaerythritol

Rosin adduct, di-(di) Glycerol

Rosin adduct, tetra-(tri) Glycerol

Fumaropimaric acid

Fumaropimaric acid

Maleopimaric acid

Maleopimaric acid/anhydride

Non-reacted rosin acids

Abietic acid

Neoabietic acid

Palustric acid

Levopimaric acid

Dehydroabietic acid

Hydroabietic acid

Pimaric acid

7,15-pimaradienoic acid

Delta Pimaric acid

Isopimaric acid

Sandaracopiramic acid

Delta Isopimaric acid

Communic acid

Anticopatic acid

Lambertiaric acid

Mercusic acid

Acetylisocupressic acid

Acetylimbricataloic acid

Imbricataloic acid

Fatty acids

16:0 fatty acid

16:1 fatty acid

18:1 fatty acid (9)

18:2 fatty acid (9,12)

18:3 fatty acid (5,9,12)

20:3 fatty acid (5,11,14 + 7,11,14)

Neutral fraction

Abietadiene

Pimaradiene

Isopimaradiene

Palustradiene

Dehydroabietadiene

Abietal

Pimaral

Isopimaral

Palustral

Dehydroabietal

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 (Table 9). 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.