Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.005 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.053 mg/L

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.212 ng/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:
0.005 ng/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
3.3 mg/kg food
Assessment factor:
300

Additional information

Formaldehyde, reaction products with ethylenediamine did not result a dangerous substance for aquatic organisms in the short-term studies performed. The lowest eco-toxicity value, the EC50of 5.3 mg/L based on algal yield, does not involve neither an acute hazard for the aquatic environment, nor a long-term risk, because of the rapid degradation of the substance and of its low bioaccumulation potential.

Conclusion on classification

According to Regulation 1272/2008/EC, formaldehyde, reaction products with ethylenediamine is classified neither for Aquatic Toxicity class nor for the hazard to the ozone layer.