Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.033 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.003 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
no emission to STP expected

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.36 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.036 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
hazard related to composition of atmosphere 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

Regulation (EC) No 2037/2000 Of The European Parliament and of The Council of 29 June 2000 on substances that deplete the ozone layer lists within ANNEX I states that the substance is listed as a Group 1 substance. However, the registrant has a derogation in accordance with Regulation (EC) No 1005/2009 Of The European Parliament and of The Council of 16 September 2009 on substances that deplete the ozone layer that allows for use of the substance as a processing agent. The mentioned Regulation reports in Annex III, point e) the following derogation: "use of CFC-12 in the photochemical synthesis of perfluoropolyetherpolyperoxide precursors of Z-perfluoropolyethers and difunctional derivatives".

However, in accordance with the above two pieces of legislation, release is strictly controlled. As such, no release to the environment is envisaged, and hence it is deemed inappropriate to assess the following endpoints on the basis of no-release:

 

Intermittent Releases

STP

Sediment (freshwater)

Sediment (Marine)

Air

Soil

Secondary poisoning.

 

Indicative PNEC’s are provided for fresh and marine aquatic environments; these are based on the proposed data for the Fish, Daphnia and Algae that trigger environmental classification as:

 

H412: Harmful to aquatic life with long lasting effects

In practice the substance is not released, hence exposure concentrations are considered to be negligible.

Conclusion on classification

The classification was determined based on an experimental study in daphnia and predictions from validated QSAR models. The data sources have all been ranked reliability 2 according to the Klimish et al system. This ranking was deemed appropriate because the studies were either non-GLP are conducted via the use of appropriate QSARs.

 Justification for classification or non classification

The above results and identified properties triggered classification under the CLP Regulation (EC No 1272/2008) as follows:

H412: Harmful to aquatic life with long lasting effects

H420: Harms public health and the environment by destroying ozone in the upper atmosphere.