Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
1.8 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
9.2 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.18 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
10 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

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

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
1.898 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Additional information

The paper on “Monomers and Polymers - Hazard communication under REACH” prepared by the CEFIC Polymer Working Group November 2009, agreed by the Advocate General’s Opinion, and endorsed by the European’s Court decision details the follows:

 

“The only identified use of a monomer is polymerisation. It can therefore be concluded that the use descriptor system does not apply to polymers or the reacted monomers. The Sectors of Use (SU), Product Categories (PC), Process Categories (PROC) and Environmental Release Categories (ERCs) are only relevant for the monomers up to the point of polymerisation. When polymerisation takes place outside the EU, there is no identified use within the EU jurisdiction. Although a CSR needs to be submitted, as there is no identified uses, chapters 9 (exposure assessment) and 10 (risk assessment) need not be addressed”

 

The substance is a monomer in a polyimide and poly(ester)imide resin polymers which are manufactured outside of the EU. The final polymer only is imported into the EU as a polymer pellet, and the neat substance is not available outside of the polymer form. These resins are used in the manufacture of temperature-resistant products such as wire enamels, coatings, film, adhesives, insulating varnishes, coated fabrics, flame retardant fibers, oil sealants and retainers; insulation for cables and printed circuits; and laminates and composites for aerospace vehicles. As such, the polymeric form is enclosed within the matrix of these finished articles, and exposure will not occur.

Conclusion on classification

The substance is currently classified according to Regulation (EC) No 1272/2008 as Toxic to aquatic life with long lasting effects (H411).

Based on the results within the studies available on this substance it is deemed appropriate to apply a new classification according to Regulation (EC) No 1272/2008:

- acute aquatic category 1: H400: Very Toxic to aquatic life (EC50 < 1 mg/L)

- chronic aquatic category 1: H410: Very toxic to aquatic life with long lasting effects (NOEC < 0.1 mg/L)

As discussed above, it should also be noted that the substance is a monomer in a polyimide and poly(ester)imide resin polymers which are manufactured outside of the EU. The final polymer only is imported into the EU as a polymer pellet, and the neat substance is not available outside of the polymer form.