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:
0.1 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.023 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:
0.044 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

Aquatic toxicity

To assess the short-term toxicity of the registered substance to aquatic organisms, experimental studies of reliability 1 (Klimisch rating), based on international guidelines, are available on the three aquatic trophic levels (algae, aquatic invertebrate and fish).Among all acute data available, the fish Danio rerio is the most sensitive species with a 96h-LC50 at 1.1 mg/L based on mean measured concentrations. For the aquatic invertebrateDaphnia magna, the 48h-EC50 was determined to be 1.6 mg/L based on mean measured concentrations, and for the algae Pseudokirchneriella subcapitata, the 72h-ErC50 and ErC10 (based on growth rate) were determined to be 5.71 mg/L and 1.38 mg/L, respectively, based on initial measured concentration.

In addition, to assess the toxicity of the registered substance to microorganisms, one experimental study of relability 2 (Klimisch rating), based on international guideline, is available on Pseudomonas putida. None of the concentrations tested between 0.05 and 10 mgL resulted in an inhibition of bacterial growth of P. putida after 16 hours of exposure. Therefore, the 16h-NOEC is equivalent to 10 mg/L for this bacterial strain. However, considering the toxicity effect observed in the biodegradation studies mentioned in the present dossier, the toxic effect observed in activated sludge micro-organisms up to 84 days at the tested concentration of 2 mg/L (AkzoNobel (2012) OECD 301D study) is considered relevant for chemical safety assessment. Therefore, the estimated NOEC for the toxicity to STP micro-organisms can be expected at 1.0 mg/L (by dividing the toxic concentration by 2).

Sediment/Terrestrial toxicity

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 sub-chronic 90 days toxicity study on rats was used to derive the PNECoral.

Environmental fate and pathways

The registered substance is hydrolytically stable at any pH (from 2 to 12), not readily biodegradable but ultimately biodegradable and therefore not persistent. With a DT50 value less than 16 days obtained in the simulation biodegradationstudy (OECD Guideline 309; DT50 = 0.8 -0.9 days at 20°C), the registered substance is considered rapidly degradable for CLP. In addition, with an experimental BCF comprised between 46 and 60, the substance is not bioaccumulable. Finally, the registered substance is slightly mobile in soils with an adsorption coefficient estimated at 2013 L/Kg (log Koc = 3.30).

Conclusion on classification

No harmonised classification is available.

Data available:

- lowest L(E)C50 value comprised between 1 and 10 mg/L;

- ErC10 algae > 1 mg/L;

- rapidly degradable (according to the OECD 309 study);

- experimental BCF = 46 -60.

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