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PBT assessment

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PBT assessment: overall result

Reference
Name:
Fatty acids, C18-unsatd., reaction products with acrylic acid and polyethylenepolyamines
Type of composition:
legal entity composition of the substance
State / form:
liquid
Related composition:
Boundary Composition
Reference substance:
Fatty acids, C18-unsatd., reaction products with acrylic acid and polyethylenepolyamines
Reference substance:
Fatty acids, C18-unsatd., reaction products with acrylic acid and polyethylenepolyamines
Reference substance:
Fatty acids, C18-unsatd., reaction products with acrylic acid and polyethylenepolyamines
Reference substance:
Fatty acids, C18-unsatd., reaction products with acrylic acid and polyethylenepolyamines
PBT status:
the substance is not PBT / vPvB
Justification:

Persistence


Based on the results of the biodegradation tests, the half-life in seawater can be estimated to be ca.15 – 30 days (see Section 4.1 of CSR). As the UVCB substance consists of homologous structures and is shown in two instances, to meet the biodegradation test criterion (>60% in 28 days), it can be concluded that the underlying constituents comprising the complex substances are not expected to be persistent. See Section 4.1.2.4. of CSR for further discussion of this endpoint.


 


Bioaccumulation


An inherent property of chemicals with surfactant properties such as those found in fatty acids, C18-unsatd., reaction products with acrylic acid and polyethylenepolyamines is that they accumulate at the interface between phases rather than equilibrating between phases. Therefore, the accurate measurement of the log Kowof any chemical with surface-active properties is difficult. Even if such measurements were made accurately, the log Kow may not be an appropriate value by which to predict the partitioning behaviour of this group of chemicals in the environment because of the tendency of surfactants to partition at lipid/aqueous interfaces. In addition, the OECD Guidelines (107/117) for determination of the Partition Coefficient indicate that neither method is applicable to “surface-active materials” (Guideline107) or “surface-active agents” (Guideline117). Similarly, values from the models should be considered to represent only one of several components in these products.


 


Environmental release of fatty acids, C18-unsatd., reaction products with acrylic acid and polyethylenepolyamines will occur exclusively in the marine environment, where concentrations of suspended solids and organic matter are high. Such an environment would result in adsorption of this cationic substance to suspended solids and organic matter; i.e. the material in the pelagic phase with negatively charged surfaces. Strong sorption to these suspended or dissolved materials would render fatty acids, C18-unsatd., reaction products with acrylic acid and polyethylenepolyamines bio-unavailable to organisms for bioaccumulation. In addition, if any of this chemical substance is taken up by organisms, such long chain fatty acids are known to be extensively metabolised in fish and when structural alerts for bioaccumulation from this substance are entered into OECD toolbox, the results indicate they will be metabolised quickly.


 


In summary, there are no measured or calculated BCF values presented for components of this UVCB substance, mainly due to limitations in validated experimental or predictive methodologies for determining Kowfor surface active substances, and the technical considerations for testing a UVCB substance composed of surface active homologues. It is believed that the substance will have a low tendency to bioaccumulate based on the fact that these substances will adsorb strongly to suspended or dissolved materials in the marine environment, becoming bio-unavailable, and be removed from the pelagic environment to the sediment. Once in the sediment, the material is non-toxic to sediment dwellers and will then biodegrade rapidly (half-life between 15-30 days – see Section 8.1.1 of the CSR). Should any of this chemical substance be adsorbed into organisms, it is also expected to metabolise fairly quickly.


 


However, in light of the above, no conclusion can be drawn on the bioaccumulation potential of the registered substance due to lack of data.


 


Toxicity


Based on data from ecotoxicological and toxicological studies the substance does not meet the criteria for T as per the ECHA Guidance on the Application of the CLP Criteria (Version 4.1 - June 2015).


 


Summary and overall Conclusions on PBT or vPvB Properties


Fatty acids, C18-unsatd., reaction products with acrylic acid and polyethylenepolyamines does not meet the criteria of PBT or vPvB.

Likely routes of exposure:

Emission Characterisation

Fatty acids, C18-unsatd., reaction products with acrylic acid and polyethylenepolyamines is intended to be emitted solely to the marine aquatic environment through discharge from offshore oil and gas platforms.