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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 FC-72 at greater than or equal to 0.1% are either inorganic and thus not subject to PBT evaluation, or are isomers and homologues of FC-72 with physical/chemical properties essentially the same as FC-72 and therefore having PBT characteristics equivalent to FC-72. The ultimate degradation products are hydrofluoric acid (HF, CAS# 7664-39-3) and carbon dioxide which are inorganic substances not requiring a PBT evaluation.

By screening and definitive REACH PBT criteria, FC-72 is very persistent, vP. However, it is only vP in the atmospheric compartment. An evaluation of its fate in water or soil concludes that FC-72 is rapidly removed 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. Due to mixing in the atmosphere and lack of partitioning out of the atmosphere, concentrations in the biosphere will be negligible. Widespread exposure to FC-72 will not occur.

Based on the expected partitioning behavior of FC-72, 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. Further direct evidence is supplied by lack of uptake or metabolism in mammalian systems. Data from mammalian pharmacokinetic studies indicate that category member FC-770 is not taken up at all into systemic circulation nor is it metabolized. Data from repeated dose studies in rats also provide direct evidence demonstrating the absence of adverse systemic and reproductive/developmental effects as well as no potential for dermal sensitization. The calculated log Koa value indicates that FC-72 could not bioaccumulate in air-breathing animals. Collectively, data from the category mammalian pharmacokinetic studies, the mammalian toxicity studies, and the calculated Koa indicate that FC-72 will not bioaccumulate in air-breathing organisms. FC-72 is not expected to bioaccumulate in aquatic, sediment or soil organisms. FC-72 does not fulfill the criteria for bioaccumulative (“B”) or very bioaccumulative (“vB”).

Based on available data, members of this category do not induce toxicity in long-term aquatic toxicity studies at their water solubility limits (84.1 ug/L for FC-72). In addition, members of this category, including FC-72, are not classified as carcinogenic, mutagenic, or toxic to reproduction or specific target organ toxicity after repeated dosing. FC-72 does not meet the REACH “T” criteria for aquatic or mammalian toxicity. This information can be used to conclude that FC-72 does not fulfill the screening criteria for toxic (“T”).

The data show that the properties of the substance do NOT meet the criteria in Annex XIII Section 1, or while not allowing a direct comparison with all the criteria, nevertheless there is no indication that the substance has P and B properties following the result from the screening tests or other information. Substance is NOT PBT or vPvB.