Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.002 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.024 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
0.9 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.025 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:
0.05 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
66.6 mg/kg food
Assessment factor:
90

Additional information

Conclusion on classification

Environmental classification and labelling of a substance is generally based on data from short-term aquatic toxicity results, the ready biodegradability of the substance and an experimentally determined BCF (or if absent the measured octanol/water partition coefficient). Available adequate chronic toxicity data is also relevant for the assessment of long-term aquatic hazards (Regulation 286/2011/EC).          

Short-term aquatic toxicity data is available for all three trophic levels. The L(E)C50 values are 2.4mg/l, 2.7mg/L and 3.6 mg/L in fish, invertebrates and algae respectively. Since all EC50 values are > 1mg/L the substance is not classified for short-term hazards to the aquatic environment according to the CLP Regulation 1272/2008/EC.

Chronic aquatic toxicity data is only available for one trophic level (algae). Therefore, the long-term hazard has been assessed based on both:

a) The chronic aquatic toxicity data for algae (72 hr NOEC = 0.26 mg/l), which for a non-rapidly degradable substance results in a Chronic 2 classification, and

b) The acute aquatic toxicity data for the other 2 trophic leves (Daphnia 48h EC50 = 2.7 mg/L, Fish 96h LC50 = 2.4mg/L) and environmental fate data (not readily but inherently biodegradable; log Kow of 3.1 -3.2), which results in a Category Chronic 2 classification,

and classifying according to the most stringent outcome.

Thus it is concluded that the substance is classified Aquatic Chronic 2 (H411) according to the CLP Regulation 1272/2008/EC & adaptation 286/2011/EC.

Under the old DSD regulation the substance would be classified as R51/53 (toxic to aquatic organisms and may cause long-term adverse effects in the aquatic environment).