Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.117 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1.17 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.012 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
0.6 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.47 mg/kg sediment dw

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.047 mg/kg sediment dw

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.24 mg/kg soil dw

Hazard for predators

Secondary poisoning

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

Additional information

Conclusion on classification

Based on the NOEC value 11.7 mg/L from the 21-day Chronic Daphnia study and the GHS system, CHDM DGE will be classified as aquatic category chronic 3.  

For the acute aquatic endpoint, the LC50 values are between 10.1 -26.7 mg/l for all the three trophic levels {10.1 mg/L (96-hour LC50 values for rainbow trout), 16.3 mg/L (48-hour EC50 value for D. magna), and 26.7 mg/L (72-hour EC50 based on growth rate for S. capricornutum)} which results in an acute aquatic category 3 according to the GHS system.