Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
6.13 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:
1 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 regarding environmental hazards

Aquatic compartment

In accordance with Regulation (EC) 1272/2008 Annex VI Table 3.1, the substance is not officially classified.

In accordance with Regulation (EC) 1272/2008 Annex VI Table 3.2, the substance is not officially classified.

 

Self-classification

Aquatic compartment

Following DSD/DPD, the substance is classified as dangerous for the environment (R52/53).

Rationale:

- The acute toxicity to aquatic organisms (LL/EL50) is between10 and100 mg/L (loading).

-The substance is not readily biodegradable.

 

Following GHS, the substance is not to be classified as acutely hazardous to the aquatic environment. Based on the available acute data, the substance is to be classified as chronically hazardous to the aquatic environment into the Category Chronic 3.

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.

Chronic data are available only for algae, therefore classification is based on the available chronic and acute toxicity data.

- Chronic toxicity data:

Chronic data are available only for algae (NOErL = 1 mg/L; ErL10 = 2.55 mg/L; loading; (#)) indicating that the substance does not present a long-term hazard according to the categories outlined in Table 4.1.0(b) (i) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008) for non-rapidly degradable substances.

- Acute toxicity data:

Acute toxicity to aquatic organisms (LL/EL50) is between10 and100 mg/L (loading).

The substance is not rapidly biodegradable and the log Kow is expected to be ≥4.

(#) The ErL10 was determined to be 2.55 mg/L (loading) and the NOErL was 1.0 mg/L (loading). According to the Guidance on information requirements and chemical safety assessment Chapter R.10: Characterisation of dose [concentration]-response for environment "an EC10 for a long-term test which is obtained using an appropriate statistical method (usually regression analysis) will be used preferentially. [...] There has been a recommendation within OECD in 1996 to phase out the use of the NOEC, in particular as it can correspond to large and potentially biologically important magnitudes of effect. The advantage of regression method for the estimation of ECx is that information from the whole concentration-effect relationship is taken into account and that confidence intervals can be calculated. These methods result in an ECx, where x is a low effect percentile (e.g. 5-20%). It makes results from different experiments more comparable than NOECs." Therefore, the EL10 (loading) instead of the NOEL (loading) has been used to derive the classification