Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

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:
0.842 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.084 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:
0.111 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

Aquatic toxicity:

Valid acute studies based on international guidelines are available for the three aquatic trophic levels (algae, aquatic invertebrates and fish). Among all data available, a toxic effect was observed for the three aquatic trophic levels. The fish Danio rerio is the most sensitive species with a 96h-LC50 value at 52.0 mg/L based on analytically confirmed nominal concentration. For the algae Pseudokirchneriella subcapitata, the 72h-ErC50 and 72h-NOEC values based on growth rate were determined to be greater than the highest tested concentration 67.9 mg/L and 16.6 mg/L, respectively, based on geometric mean measured concentrations. For the aquatic invertebrates Daphnia magna, the 48h-EC50 value was determined to be 108 mg/L based on analytically confirmed nominal concentration. In addition, the registered substance was not toxic to activated sludge of a municipal sewage treatment plant up to the nominal concentration of 100 mg/L.

Sediment, terrestrial toxicity and hazard for predators

In the absence of any ecotoxicological data for sediment-dwelling/soil organisms, the PNEC sediment/soil were calculated using the equilibrium partitioning method (EPM). Furthermore, no toxicity studies reporting the secondary poisoning effects on bird were available, therefore the 28-day toxicity study on rats performed on the registered substance was used to derive the PNECoral.

Environmental fate and pathways:

The registered substance is considered readily biodegradable and therefore is notPersistent (P) or very Persistent (vP) in the environment.

Also, the registered substance is considered highly mobile in soils with a log Koc values at 2.0 for soil (Koc = 100) and 2.1 for sewage sludge (Koc = 126), and with a log Kow value at 3.32, the substance is not considered to be bioaccumulative according to CLP (< 4.0) and PBT criteria (< 4.5).

Conclusion on classification

No harmonised classification is available on the registered substance.

10 < lowest E(L)C50 value < 100 mg/L; EC10 or NOEC algae > 1 mg/L; rapidly biodegradable; log Kow = 3.32.

Classification according to the Annex VI of the Regulation (EC) No 1272/2008 (CLP): The registered substance is not classified for the environment.