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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:

Tetrafluoroethylene (TFE) is a gas (B.P. -76°C) of low water solubility. As consequence, exposure of the aquatic environment, sediments and soil is unlikey. Further, an assessment of the PBT status of Tetrafluoroethylene (TFE) has been made using all available data. This information suggets that that tetrafluoroethylene does not meet the criteria for PBT/vPvB.

Persistence

Tetrafluoroethylene is a gas (B.P. - 76°C) of low water solubility and when released to the environment will enter almost exclusively the ambient air. It has little tendency to paritition to biota or soil. Because of its low sorption affinity, TFE is expected to be mobile in soil. The most important degradation process occurs in the atmospheric compartment. Consequently TFE will not be persistent in the aquatic environment.

Bioaccumulation

The estimated log Kow of TFE is 1.21, and hence biocaccumulation is not expected. TFE is therefore considered not bioaccumulative.

Toxicity

The estimated acute effect concentrations are much higher than the screening criterion of 0.1 mg/l. It can therefore be expected that TFE is not toxic towards aquatic organisms. The chronic effect concentrations for invertebrates, fish and algae are likely to be much higher than the defined criterion of 0.01 mg/l. TFE is not classified as mutagenic or toxic for reproduction, and because the substance is a gas with short atmospheric lifetime chronic exposure of mammals is unlikely. However, TFE is classified as carcinogenic in experimental animals by a non-genotoxic mechanism (category 1B according to Regulation 1272/2008 and category 2 according to Directive 67/548/EEC). Therefore, by the screening criteria TFE can be considered as Toxic.

Conclusion

The overall conclusions, of the PBT assessment are that the criteria for PBT / vPvB are not met, and that TFE can be considered to be not PBT/vPvB.