Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.012 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.12 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
PNEC marine water (intermittent releases):
0.012 mg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.028 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:
0.038 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
10 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.

For aquatic invertebrates Daphnia magna, a 48h-EC50 value of 21.7 mg/L was determined based on analytically confirmed nominal concentration.

For fishes, Danio rerio, the 96h-LC50 value was determined to be 23.0 mg/L based on analytically confirmed nominal concentration.

For the algae Pseudokirchneriella subcapitata, the most sensitive organisms, 72h-ErC50 and 72h-EC10 values based on growth rate were determined to be 12.0 (11.1 - 13.7) mg/L and 8.7 mg/l respectively, based on measured concentrations (geometric mean of T0 and 72 h measurements).

In addition, the registered substance was not toxic to activated sludge of a municipal sewage treatment plan up to the nominal concentration of 10 mg/L (NOEC value) and an EC10 value of 24.4 mg/l was determined based on inhibition of total respiration.

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:

According to the weight of evidence approach for biodegradation endpoint,the registered substance is classified as not readily biodegradable within 28 days.Under the extended study period of 60 days (OECD 301F, non-GLP), a biodegradation of min 70% was reached. This indicated that the registered substance is inherently and ultimately biodegradable.The registered substance can be considered to be non-persistent.

Also, the registered substance is considered mobile in soils with a log Koc values at 2.0 -2.1 for soil (Koc = 100-150) and 2.0 - 2.5 for sewage sludge (Koc = 100-316), and with a log Kow value at 2.69, the substance is not considered to be bioaccumulative according to CLP (< 4.0) and PBT criteria (< 4.5).

Conclusion on classification

The registered substance is classified as Aquatic toxic chronic 3 according to available data based on CLP criteria:

10 < lowest E(L)C50 value < 100 mg/L; EC10 or NOEC algae > 1 mg/L; not readily biodegradable; log Kow = 2.69.