Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no hazard identified

STP

Hazard assessment conclusion:
no emission to STP expected

Sediment (freshwater)

Hazard assessment conclusion:
no exposure of sediment expected

Sediment (marine water)

Hazard assessment conclusion:
no exposure of sediment expected

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no exposure of soil expected

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

In well conducted aquatic toxicity studies on fish, daphnia and algae, PFBE showed no toxicity at the highest concentrations achievable (maxium loading rate 1000mg/l). Thus no hazard has been identified and no PNEC is derivied.

Though not readily biodegradable, PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) is not likely to persist in surface waters due to its low water solubility (15.6 mg/l), high vapour pressure (22kPa at 20°C) and estimated Henry's Law constant (3 - 100 atm.m3.mol-1). As a result, releases of PFBE to the aquatic environment are likely to rapidly partition to atmosphere, and detectible concentrations in water will be hard to acheive. PFBE has only moderate affinity for soil (measured log Koc = 2.96 Koc = 903). Volatilisation from wet and dry soil surfaces is expected to be an important fate process, based on the estimated Henry's law constant and this compound's high vapour pressure.  Any PFBE released into the environment is expected to partition almost entirely to the atmosphere, where it will quickly react with atmospheric hydoxyl radicals (°OH), with a short atmospheric lifetime, estimated to be 6.4 hours.

Moreover, direct and indirect exposure of the aquatic compartment, sediment and soil is considered unlikely (See the document PFBE: REACH Annex IX waivers for Degradation and Fate and Behaviour in the Environment. Blue Frog Scientific Limited. Attached to Section 5 Summary Environmental Fate and Pathways).

Conclusion on classification

In well conducted aquatic toxicity studies on fish, daphnia and algae, PFBE showed no toxicity at the highest concentrations achievable (maximum loading rate 1000mg/l). Thus no hazard has been identified and no PNEC is derived.Therefore PFBE does not need to be classified as Dangerous for the Environment in Acute Category 1 or Chronic Categories 1,2, or 3 according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. Although PFBE is not rapidly degradable, the extreme volatility of the substance would result in near complete volatilisation, coupled with rapid atmospheric degradation, ensuring that the substance is rapidly removed from the aquatic compartment and degraded from the environment as a whole. In conclusion PFBE meets the “rapidly degradable” criteria set for non-classification as Chronic Category 4 due to its ultimate environmental fate.