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PBT assessment

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PBT assessment: overall result

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

Based on the available data the substance does not fulfil the criteria for PBT assessment under Annex XIII. Concerning persistence, the substance is not biodegradable, and the half life is bordering or above the criteria for all components of the registered substance.

No data is available on bioaccumulation, however the substance has limited solubility and the substance would tend to partition from water to sediment. No toxicokinetic data are available concerning absorption in mammalian systems, however, from the partition coefficient adsorption is estimated to be extremely slow.

Concerning toxicity, little information is available assessing the long-term toxicity in the aquatic environment, however examining the data available from repeated dose toxicity the substance does not not fulfil the criteria for toxic.

As the substance is imported into the EU only in it’s polymerised form, as such the registered substance does not pose a risk to the environment as no exposure is anticipated.

Likely routes of exposure:

Emission characterisation of the registered substance is not appropriate as the substance is neither manufactured nor imported into the EU in it’s monomeric form. Emmision of the monomer is mediated by release from the polymer.