Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.031 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.003 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
no data: aquatic toxicity unlikely

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.017 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:
0.035 mg/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

The results from the aquatic toxicity studies are as follows:

  • ErC50 (72h) algae = 0.0053 mg/L (geometric mean of the measured concentrations) with 95% confidence limits of 0.048 - 0.0057 mg/L
  • EC50 (48h) daphnies = 0.011 mg/L (measured concentrations) with 95% confidence limits of 0.0094 - 0.013 mg/L
  • NOECchronic fish = 40 µg/L (nominal concentrations, based on measured concentrations showing a stable exposure concentration within 80 -120% of nominal over the entire exposure period)
  • NOECchronic daphnids = 0.308 µg/L (geometric mean of the measured concentrations
  • EC50 microorganisms: no study available, but during the biodegradation test, no microbiological toxicity was observed.

The classification for acute toxicity based on the lowest short term data for algae (EC50 = 5.3 µg/l) is Aquatic Acute 1 H400 with a M factor of 100. With no biodegradation the classification Aquatic chronic 1 is also relevant with a M factor = 100.

Based on the results from the short-term aquatic toxicity tests and since the substance is not biodegradable and has a log Kow of > 4, the substance is classified as Aquatic Acute 1 (Hazard statement H400 - Factor M = 100) and Aquatic Chronic 1 (Hazard statement: H410 - Factor M = 100) according to the CLP Regulation 1272/2008.