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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:

Rosin Adducts and Rosin Adducts Salts substances are UVCB substances made up of constituents with different properties, which will behave differently when released to the environment. The PBT assessment of Rosin Adducts and Rosin Adducts Salts 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 3 are expected to be similar and therefore a single PBT assessment covering all of the constituents in this category is justified. 

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 experimental data on Persistence (P) and Bioaccumulation (B) of the registered substance or its individual constituents. However, in 2015, a PACT assessment was published by the Finnish Competent Authority, Tukes, which carried out a PBT assessment for rosin, maleated (Tukes 2015). The assessment includes information on both maleopimaric acid / anhydride and fumaropimaric acid and therefore the assessment is relevant for both fumarated and maleated substances within this category. The PACT assessment reviewed both measured data and conducted QSAR predictions for representative constituents. QSAR predictions conducted using Episuite’s BIOWIN model for constituents maleopimaric acid / anhydride and fumaropimaric acid indicate the persistence criteria may be met, and the substance is potentially persistent (P). This assessment has been reviewed and updated to ensure all the likely constituents have been covered and that the EPIsuite Predictions are valid and up to date. 

The blocks and their representative constituents that were assessed are listed inTable1.

Following the Screening assessment 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. 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.

Table1 Blocks present in this category and representative structures for each block.

Block

Constituent

Fumaropimaric acid

Fumaropimaric acid

Maleopimaric acid

Maleopimaric acid/anhydride

Maleopimaric anhydride

(4α,8α,12α,13R,14S)-16-isopropyl-17,19-dinoratis-15-ene-4,13,14-tricarboxylic acid EC No: 204-748-0 - (cis-maleopimaric tricarboxylic acid)

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

High molecular weight fraction

Reaction of fumaric or maleic acid with levopimaric acid dimer; tetracarboxylic acid (open)form

Reaction of fumaric or maleic acid with levopimaric acid dimer; tricarboxylic acid (closed/anhydride) form