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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

Reference
Name:
MEFBSE
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
MEFBSE
PBT status:
the substance is not PBT / vPvB
Justification:

Log Kow results are available for all constituents, impurities, and transformation products, and additionally BCF results are available for some. In all cases log Kow values are less that three, and none of the constituents, impurities, or transformation products are expected to bioaccumulate by a lipid partitioning mechanism. A theory has been presented that members of the perfluoroalkyl acid substance category and their derivatives bioconcentrate by a protein binding mechanism, and therefore that the log Kow is not a relevant data point. However, the weight of evidence indicates that short chain acids do not bioconcentrate in animals, and therefore that a protein-binding mechanism does not operate. In bioconcentration studies done on perfluorobutanesulfonic acid and perfluorobutanoic acid, BCF values were <30. Transformation products of somewhat greater functionality, such as the C4 glycine acid, are similarly not expected to undergo protein-binding and are unlikely to bioconcentrate by a protein binding mechanism. None of these constituents, impurities, or transfomation products are expected to bioaccumulate, and many have been shown not to bioaccumulate. Therefore, the substance itself, its impurities, and its transformation products are not PBT/vPvB substances according to the criteria laid out in Annex XIII of EC1907/2006, the REACH regulation.  Therefore, MeFBSE as submitted is not a PBT or vPvP substance.