Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.02 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.002 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.1 mg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
1.9 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:
2.3 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Conclusion on Classification:

Adequate aquatic chronic toxicity information from all three trophic levels was not available; therefore, the classification was based on the results from two short-term aquatic toxicity tests (72-h ErLR50 > 100 mg/L mg/L reported from an algal growth inhibition test on the substance, and 96-h LLR50 > 100 mg/L reported from an acute fish toxicity test on an analogue substance through read-across), and the results from two long-term aquatic toxicity tests (NOErLR = 11 mg/L from an algal growth inhibition test on the substance, and NOELR of ≥ 1.0 mg/L reported from a daphnid reproduction test on an analogue substance through read-across, in which no adverse chronic effects were observed). Ready biodegradability was demonstrated on an analogue substance through read-across, which exhibited 69% degradation in 29 days. Although the predicted octanol-water partition coefficient (log Kow) of 5.34 is above the criterion (log Kow≥ 4.0) for possible environmental classification, the predicted bioconcentration factor (BCF = 65.4 L/kg w.w.), estimated by a validated QSAR model (EPI Suite BCFBAF v3.01), is below the criterion of concern for both food chain exposures (BCF ≥ 100) and environmental classification (BCF ≥ 500),  Each short-term and long-term toxicity test concentration was based upon the water accommodated fraction, wherein the nominal loading rate exceeded the estimated water solubility of the substance. Even though no acute toxicity was observed at loading rates above the estimated water solubility, the safety net classification (Chronic Category 4) does not apply since the substance was determined to exhibit ready biodegradability.  In summary, the substance does not meet the criteria for classification as an acute or chronic environmental hazard, based on either the available short-term or long-term toxicity results.