Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
70.4 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:
0.139 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
13.33 mg/kg food
Assessment factor:
300

Additional information

Due to the low solubility and complex nature of the test item, media for investigations of short-term aquatic toxicity were prepared as a Water Accommodated Fractions (WAFs). Given that the toxicity cannot be attributed to a single component or a mixture of components, but to the test item as a whole, results were based on nominal loading rate.

Conclusion on classification

The test item is not classified as acutely toxic to the environment because the lowest EL50 value (determined for algal growth rate) was > 1 mg/L. However, the substance is not readily biodegradable, has been determined to be slightly soluble (16.1 mg/L) and Log Kow was reported as ≥ 4 for cationic and anionic constituents. These data potentially indicate concern for the environment and, since long-term toxicity data are available for only one trophic level (algae), aquatic toxicity results were assessed in terms of substances for which adequate chronic toxicity data are available and substances for which adequate chronic toxicity data are not available. The most stringent classification outcome was then applied. Based on the EL50 value of 1.8 mg/L determined for algal growth rate, classification as Aquatic Chronic 2 is applicable when the result is compared to criteria given by Regulation (EC) No 1272/2008 (2nd ATP; 10 March 2011) for non-rapidly biodegradable substances for which adequate toxicity data are not available.