Rosin, fumarated

PBT assessment

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