Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.091 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.076 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.009 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.314 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:
0.164 mg/kg soil dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Official classification:

Aquatic compartment

In accordance with Regulation (EC) No 1272/2008, Annex VI Table 3.1, the substance is officially classified as Aquatic Chronic 2.

 

Self-classification:

Aquatic compartment

Following CLP, the substance is not to be classified as acutely hazardous to the aquatic environment. Based on the available chronic data, the substance is to be classified as chronically hazardous to the aquatic environment.

 Rationale:

The substance is not to be classified as acutely hazardous to the aquatic environment, since the lowest acute effect value is > 1 mg/L (aquatic invertebrates: 48-h EC50 = 7.59 mg/L; see IUCLID Ch. 6.1.3).

Chronic data are available for all three trophic levels: fish, aquatic invertebrates and algae; therefore, classification is based on the chronic toxicity data alone.

The lowest chronic effect level was determined for fish (35-d NOEC = 0.91 mg/L; see IUCLID Ch. 6.1.4). According to the criteria outlined in Table 4.1.0(b)(ii) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008 for rapidly degradable substances), the substance is to be classified as chronically hazardous to the aquatic environment (Aquatic Chronic 3).

Conclusion:

Based on the chronic toxicity data, the substance is to be classified as chronically hazardous to the aquatic environment. Based on the available experimental data, the appropriate category is Aquatic Chronic 3; however, the harmonized classification as Aquatic Chronic 2 overrides the self-classification.