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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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

Whole substance screening level data are available for the assessment of biodegradation and bioaccumulation for rosin adduct substances. However, considering the substances as a whole is not considered to be the most appropriate method for assessing the PBT potential of complex UVCB substances such as these, as different constituents will have different environmental fate properties.

Whole substance ready biodegradation studies are available, and based on the results from these studies category members are not considered to be readily biodegradable. However, as different constituents within a UVCB substance are likely to have differing biodegradation potential these studies are not considered to be appropriate for assessing the persistence potential of the substances. Instead an assessment based review of individual constituents within the UVCB substances is considered to be more appropriate.

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).

Measured log Kow values for category members range from 0.4 - >6.5. However, measured partition coefficient values for the whole substance are not considered to be appropriate for complex UVCB substances such as these, as different constituents will have different partitioning behaviour. The PBT assessment for these substances is therefore conducted based on a review of constituents within the UVCBs. The Finnish Competent Authority, Tukes, produced a PACT assessment for Rosin, maleated (Tukes 2015). For bioaccumulation, the PACT assessment reports predicted logD (pH specific log Kow values) and these indicate that at environmentally relevant pH, log Kow values for these constituents are <4.5. Predicted log BCFs are also low. It is not clear from the summary document exactly which structures were modelled, but due to the similarity of constituents between substances in this category, the conclusions for rosin, maleated are also considered to be relevant for other maleated and fumarated substances within the category. In addition, resin acids constituents, which will also be present within all rosin adduct substances, are not considered to be bioaccumulative based on measured data for both fish and mussels (Niimi and Lee 1992, Burggraaf et al. 1996). The PACT assessment concludes that rosin, maleated is not bioaccumulative (B) or very bioaccumulative (vB) and this conclusion is considered to be appropriate for other category members as well.

The PACT assessment concludes that rosin, maleated is not toxic (T), based on measured data from studies conducted with the whole substance and Ecosar predictions for maleopimaric acid/anhydride. This conclusion is also considered to be relevant for other rosin adduct substances. Acute ecotoxicity studies are available in the REACH dossiers for rosin adduct substances, with data available for fish, Daphnia and algae. The lowest acute ecotoxicity result is a 96-hour EC50 of 4.8 mg/L for fish exposed to resin acids and rosin acids, maleated, sodium salts. This result also supports that members of this category are not T.

None of the substances included in H4R Category 3 are classified as carcinogenic (cat. 1A or 1B), germ cell mutagenic (cat. 1A or 1B), toxic to reproduction (cat. 1A, 1B or 2), STOT RE 1, or STOT RE 2. 

Overall, substances in the rosin adducts category are not considered to be PBT or vPvB. This conclusion is supported by the PACT assessment conducted by Tukes for rosin, maleated which concluded ‘the substance is not considered to meet the PBT/vPvB criteria based on the available, mainly screening level, information’.

Tukes (2015) Hazard assessment outcome document for Rosin, maleated EC No 2332-480-4 CAS No 8050-28-0 Version 1.2 Dated: 30 March 2015https://echa.europa.eu/addressing-chemicals-of-concern/substances-of-potential-concern/pact/-/substance-rev/8051/del/50/col/synonymDynamicField_3413/type/desc/pre/6/view