Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.11 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
1.1 µg/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:
83.1 µg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
8.31 µg/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:
16 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Additional information

Aquatic toxicity:

Valid acute studies based on international guidelines are available for the three aquatic trophic levels (algae, aquatic invertebrates and fish). A toxic effect was observed for the three aquatic trophic levels.

Aquatic invertebrates, Daphnia magna, are the most sensitive species with a 48h-EC50 value at 1.1 mg/L based on time-weighted mean concentrations.

For the algae Pseudokirchneriella subcapitata, the 72h-ErC50 and 72h-ErC10 values based on growth rate were determined to be 2.6 and 1.5 mg/L, respectively, based on time-weighted mean concentrations.

For the fish, Danio rerio, the 96h-LC50 value was determined to be 4.07 mg/L based on the geometric mean of the measured concentrations.

For micro-organisms, the effect of the test item on the respiration of activated sewage sludge micro-organisms gave a 3-Hour EC50 value of greater than 100 mg/L.

Environmental fate and pathways:

The registered substance is not considered readily biodegradable and therefore it can be considered as a potential Persistent (P) in the environment.

Also, the registered substance is considered low mobile in soils with a logKoc values at 2.86 (Koc=724) and with a log Kow value at 3.12,the substance is not considered to be bioaccumulative according to CLP (< 4.0) and PBTcriteria(< 4.5).

Conclusion on classification

No harmonised classification is available on the registered substance. Nevertheless:

- the substance is not readily biodegradable,

- log Kow= 3.12

- For Daphnia and fish, 1 > lowest E(L)C50 value 10 mg/L; and for algae, 1> ErC50 10 mg/L

Classification according to the Annex VI of the Regulation(EC) No 1272/2008 (CLP): The registered substance is classified for the environment as Aquatic Toxic Chronic 2.