Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
7.65 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
76.5 µg/L

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
7.7 mg/L
Assessment factor:
1
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.004 mg/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:
0.003 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Hazard to aquatic organisms was assessed based on a single key study for each trophic level tested, and consisted of the following:

- (Allen, 2013) Acute toxicity to Oncorhynchus mykiss, conducted in accordance with OECD 203 "Fish Acute Toxicity Test";

- (Allen, 2013) Acute toxicity to Daphnia magna, conducted in accordance with OECD 202 "Daphnia sp., Acute Immobilisation Test";

- (Allen, 2013) Acute toxicity to Pseudokirchneriella subcapitata, conducted in accordance with OECD 201 "Freshwater Algae ane Cyanobacteria, Growth Inhibition Test";

A weight-of-evidence approach was used to define the effect levels presented for toxicity to microorganisms, based on a combination of studies owned by the Registrant, and from the literature. The PNECSTP was therefore based on the following studies:

NOEC = 10 mg/L, activated sludge, OECD 209, Allen (2013)

NOEC = 700 mg/L, P. putida, DIN 38412, part 8 (Pseudomonas Zellvermehrungshemm-Test) , Bringmann & Kuhn (1977)

NOEC = 3,140 mg/L, U. parduczi, Bringmann & Kuhn (1980)

NOEC = 7.7 mg/L, C. paramecium, Bringmann et al., (1980)

Conclusion on classification

In accordance with the criteria of Regulation (EC) No 1272/2008, the substance does not meet the criteria for environmental classification.