Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.001 mg/L
Assessment factor:
10
PNEC freshwater (intermittent releases):
0.03 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
100

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.005 mg/kg sediment dw
Assessment factor:
1

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0 mg/kg sediment dw
Assessment factor:
10

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
1 mg/kg soil dw
Assessment factor:
1 000

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
0.8 mg/kg food
Assessment factor:
90

Additional information

Since a full base set of acute aquatic test data is available, as well as the 21-day NOEC for reproduction of Daphnia magna, a 72-hour NOEC for growth rate of Pseudokirchneriella subcapitata, and a 90-day rainbow trout NOEC for an analog substance, an assessment factor of 10 is appropriate for calculation of a PNEC aqua-freshwater. The Predicted No Effect Concentration for surface water is PNEC aqua-freshwater= 0.0047 mg/L (0.00093 mg/L corrected for 20% a.i.).
The PNEC aqua-marine water was derived from the PNEC aqua-freshwater. The PNEC for freshwater sediment was derived from the PNEC aqua-freshwater, the Koc value for the dominant non-aqueous-phase constituent in the test substance (Koc = 17 mL/g) and appropriate equilibrium partitioning equations. The PNECs for marine sediment was derived from the PNEC aqua-marine water, the Koc value for the dominant non-aqueous-phase constituent in the test substance (Koc = 17 mL/g) and appropriate equilibrium partitioning equations. The PNEC for soil was derived from the 14-day LC50 from an acute study with earthworms. The PNEC STP was derived from the respiration inhibition study 3-hr NOEC value of 1000 mg/L in conjunction with an AF of 10. The PNEC oral (secondary poisoning) was derived from the 90-day rat study NAEL of 3.6 mg a.i./kg/day, a conversion factor or 20, and an assessment factor of 90.

Conclusion on classification

The lowest aquatic effect concentration for the test substance is available from a 21-day Daphnia magna flow-through life cycle reproduction study. The NOEC and LOEC values from this study based on mean measured test concentrations are 0.0467 and 0.105 mg/L, respectively (0.0093 and 0.021 mg/L, respectively when corrected for 20% a. i.). The NOEC from the Daphnia magna chronic study coupled with the observed lack of ready biodegradation for the substance were used to determine the appropriate classification and labelling for the substance:
Aquatic Chronic Cat 1 (very toxic to aquatic life with long lasting effects).