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Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.53 mg/kg sediment dw
Assessment factor:
1
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.053 mg/kg sediment dw
Assessment factor:
1
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:
0.107 mg/kg soil dw
Assessment factor:
1
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The PNEC for freswater is calculated with the use of a factor of 1000 on short-term toxicity data which is a conservative and protective factor. For PNECsediment and soil the equilibrium partitioning method (EPM) was used with a Koc value extrapolated from the Log Kow which was difficult to assess according to the very low solubility of the dye. As exposure using the model EUSES implemented in Chesar is also using the same value of Koc the ratio PEC/ PNEC is considered only as a screen for assessing the level of risk to sediment/soil dwelling organisms .

For substances with a log Kow greater than 5 (or with a corresponding Kpsed) the equilibrium partitioning method is used in a modified way in order to take account of possible uptake via ingestion of sediment or by soil ingestion. Thus the resulting PEC/PNEC ratio should be increased by a factor of 10 for these compounds.

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)
  • 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.

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