Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
2 500 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
250 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:
300 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

Conclusion on classification

In the absence of adequate aquatic chronic toxicity information from all three trophic levels, the classification was based on short-term aquatic toxicity values (72-h ErLR10 > 100 mg/L in algae, 48-h ELR10 > 100 mg/L in daphnids, and 96-h NOEC = 10,000 mg/L in fish). Based on the results of these three tests, no toxicity was observed in any of the three trophic levels; furthermore, there is no evidence that the acute toxicity tests do not provide a true measure of the intrinsic aquatic toxicity of the substance. Although the substance was not shown to be readily biodegradable, the substance exhibited inherent primary degradability (i.e., 21.8%). Therefore, while the substance is not expected to be very persistent in the environment, it does exhibit the potential to be persistent. The predicted bioconcentration factor (BCF = 227.7 L/kg w.w.), estimated by a validated QSAR model (EPI Suite BCFBAF v3.01), is above the criterion of concern for food chain exposures (BCF ≥ 100), and the. predicted octanol-water partition coefficient (log Kow) of 9.39 is above the criterion (log Kow≥ 4.0) for possible environmental classification. Therefore, food chain exposures and bioaccumulation of the substance are of potential concern. In summary, although there is no evidence that the acute toxicity tests do not provide a true measure of the intrinsic aquatic toxicity of the substance, the substance exhibits the potential to be persistent or bioaccumulative in the environment. Therefore, the substance was assigned a Category Chronic 4 classification.