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EC number: 266-040-8
CAS number: 65997-04-8
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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