Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
62.8 ng/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.628 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:
0.655 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
65.5 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:
0.131 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

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 information is available for all three trophic levels. The L(E)C50 values for daphnia and fish are < 1mg/L. Therefore the substance is classified Category Acute 1 (H400) 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 = 1.83 mg/l), which results in no chronic classification because the value is > 1 mg/L, and 

b) The acute aquatic toxicity data for daphnia (EC50 =0.9 mg/L), fish (LC50 = 0.628mg/L, QSAR) and environmental fate data (not readily biodegradable and log Kow of 5 for main isomer), which results in a Chronic 1 classification, and classifying according to the most stringent outcome. 

Thus it is concluded that the substance is classified Category Chronic 1 (H410) for long-term hazards to the aquatic environment according to the CLP Regulation 1272/2008/EC & adaptation 286/2011/EC.

According to Regulation (EC) No. 286/2011, Table 4.1.3, in order to classify a mixture containing the substance an M-factor of 1 should be used when applying the summation method since the EC50 is > 0.1mg/L and <= 1mg/L. The M-factor of 1 applies to both the Acute 1 and Chronic 1 classification.