Registration Dossier

Diss Factsheets

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):
3.4 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:
4.8 µg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.48 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:
0.75 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

Short-term fish toxicity study is available on the read across substance, ‘mono- and di-C16 PSE, K+’ and a Daphnia and algae toxicity studies are both available on read across substance, ‘mono- and di-C16 PSE, K+ and H3PO4’. No toxicity was found in the three trophic levels and the L(E)C50 values were established at the highest tested concentrations (nominal and/or measured). The lowest EC50 value based on measured concentrations was determined to be >0.34 mg/L from the Daphnia study with the read across substance, which can be considered to exceed the maximum soluble concentration of the substance in test medium following addition of nominal concentration of 10 mg/L. Further, the test substance is considered to be inherently biodegradable (based on read across study) and has a low bioaccumulation potential (based on weighted average estimated BCF of 491.26 L/kg). Therefore, in absence of further studies to indicate otherwise, the test substance, ‘mono- C16 PSE and C16-OH’ warrants a safety net Chronic 4 aquatic classification according to EU CLP criteria (Regulation 1272/2008/EC).