Hexafluoropropene, oxidized, oligomers, reduced, fluorinated

Bioaccumulation: aquatic / sediment

Administrative data

Endpoint:

bioaccumulation in aquatic species: fish

Data waiving:

study technically not feasible

Justification for data waiving:

other:

Justification for type of information:

Additional information supporting data waiving:

EXPOSURE CONSIDERATIONS
Furthermore, a bioaccumulation test in aquatic species is not deemed required. As stipulated in column 2 of Annex IX, section 9.3.2, bioaccumulation testing does not need to be conducted if direct and indirect exposure of the aquatic compartment is unlikely, or if the substance has a low potential to cross biological membranes.
A justification for the exclusion of direct and indirect exposure of the water phase can be found in the environmental fate modeling and exposure assessment performed in the dossier, and a description of the manufacturing and uses is given in the attached document. From these data, it is clear that:
1. The uses described for Galden LMW will not lead to direct exposure of the water compartment, and
2. Galden LMW will mainly partition into the air compartment, and distribution into the water phase is expected to be negligible (Indirect exposure to water is not to be expected, as the substance will not partition into water due to its high vapour pressure, high Henry’s Law Constant and its low solubility in water).

As a consequence, an adaptation of the Annex IX requirement for bioaccumulation testing in aqueous species is considered justified in accordance with the information provided in Column 2 of Annex IX 9.3.2.