Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.45 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:
0.71 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Conclusion on classification

A short-term algae study is available on the test substance 'mono- and di- C16 PSE, K+ and C16-OH and isostearyl isostearate' and the Daphnia and fish toxicity studies have been assessed based on studies available for substances representative of the main constituents (i.e., PSE, alcohol and isoalkylester). Although no toxicity was found in fish and Daphnia, which are assessed based on studies for substance representing the main constituents, but the algae study with the test substance revealed effects (on growth rate and cell densities) leading to establishment of NOEC at 0.14 mg/L. Therefore, the EC50 value of >0.34 mg/L (based on measured concentration) from the algae study with the test substance warrants an ‘Aquatic Acute 1; H400: Very toxic to aquatic life’ classification according to the EU CLP criteria (Regulation 1272/2008/EC). Further, in absence of long-term studies and given that the test substance is considered to be readily biodegradable and has a low bioaccumulation potential (based on weighted average estimated BCF of 377.7 L/kgas well as log Kow of 2.7), no aquatic chronic classification is warranted according to EU CLP criteria (Regulation 1272/2008/EC).