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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:

All impurities identified as present in HFP kinetic dimer at > or = 0.1% are isomers or homologues of HFP kinetic dimer, with physical/chemical properties essentially the same as HFP kinetic dimer. Impurities therefore have PBT characteristics equivalent to HFP kinetic dimer. The ultimate degradation products are expected to be hydrofluoric acid, trifluoroacetic acid, isoperfluorobutyric acid and carbon dioxide. HF and CO2 are inorganic substances not needing a PBT assessment and TFA and PFBA are not bioconcentrating or toxic.

By screening and definitive REACH PBT criteria, HFP kinetic dimer is very persistent, “vP”. An evaluation of its fate in water or soil concludes that HFP kinetic dimer is rapidly removed to the atmospheric compartment by volatilization, and it will not partition into water or soil from the atmosphere. Therefore, this substance is non-persistent in the aquatic and terrestrial environments. It is very persistent only in the atmosphere and is subject to long-range transport in the atmosphere but is not subject to deposition in remote or pristine environments. Due to mixing in the atmosphere and lack of partitioning out of the atmosphere, concentrations in the biosphere will be negligible. Widespread exposure to HFP kinetic dimer will not occur.

Based on the expected partitioning behavior of HFP kinetic dimer, additional laboratory studies on the biodegradation and bioaccumulation in the water, sediment and soil compartments are not relevant for the evaluation of PBT properties of this substance. The “B” criterion in aquatic organisms is not met due to lack of exposure. The calculated log Koa value indicates that HFP kinetic dimer cannot bioaccumulate in air-breathing animals. Collectively, the log Kow, the HLC, and the calculated Koa indicate that HFP kinetic dimer is not expected to bioaccumulate in aquatic, sediment or soil organisms. HFP kinetic dimer does not fulfill the criteria for bioaccumulative (“B”) or very bioaccumulative (“vB”).

Based on available data, HFP kinetic dimer is not classified as carcinogenic, mutagenic, or toxic to reproduction or specific target organ toxic after repeated dose. HFP kinetic dimer does not meet the REACH “T” criteria for mammalian toxicity. This information combined with the lack of acute aquatic toxicity can be used to conclude that HFP kinetic dimer does not fulfill the screening criteria for toxic (“T”).

The data show that the properties of the substance do NOT meet the specific criteria in Annex XIII Section 1, or while not allowing a direct comparison with all the criteria, nevertheless indicate that the substance would not have these properties. Substance is NOT PBT or vPvB.

Likely routes of exposure:

Not Applicable