Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.009 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.09 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:
480 mg/L
Assessment factor:
1
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
4.47 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:
3.67 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Deduction of PNECs is based on the Guidance Document "Guidance on information requirements and chemical safety assessment - Chapter R.10: Characterisation of dose[concentration]-response for environment" (TGD R.10) published by the European Chemicals Agency, 2008.

 

Estimates for Koc and HLC are taken from the respective programs of US EPA EPIWIN v.4.1. The calculation methods are well established and validated according to acknowledged rules. Results are considered valid in the range and scope of the calculation methods. Results are reported in the respective Sections of IUCLID and taken for the calculations.

 

PNEC sediment (freshwater)

According to chapter R.10.5.2.1 of TGD R.10, the PNEC sediment can provisionally be calculated in the absence of data for sediment-dwelling organisms using the equilibrium partitioning method (EPM).

PNEC derivation following procedures of TGD R.10 and R.16:

PNEC aqua (freshwater): 9 µg/L;

Koc: 13.69 (US EPA EPI Suite estimate, program KOCWIN v2.00, Koc estimate from log Kow; see IUCLID sect. 5.4.1);

The PNEC sediment (freshwater) was calculated to 9.72 µg/kg ww. This value was converted to dry weight (conversion factor of 4.6) resulting in a PNEC sediment (freshwater) of 44.72 µg/kg sediment dw.

 

PNEC sediment (marine water)

According to chapter R.10.5.3.1 of TGD R.10, the PNEC sediment can provisionally be calculated in the absence of data for sediment-dwelling organisms using the equilibrium partitioning method (EPM).

PNEC derivation following procedures of TGD R.10 and R.16:

PNEC aqua (marine water): 0.9 µg/L;

Koc: 13.69 (US EPA EPI Suite estimate, program KOCWIN v2.00, Koc estimate from log Kow; IUCLID sect. 5.4.1);

The PNEC sediment (marine water) was calculated to 0.972 µg/kg ww. This value was converted to dry weight (conversion factor of 4.6) resulting in a PNEC sediment (marine water) of 4.47 µg/kg sediment dw.

 

PNEC soil

According tochapter R.10.6.1 of TGD R.10, the PNEC soil can provisionally be calculated in the absence of data for soil organisms using the equilibrium partitioning method (EPM).

PNEC derivation following procedures of TGD R.10 and R.16:

PNEC water (freshwater): 9 µg/L;

Koc: 13.69 (US EPA EPI Suite estimate, program KOCWIN v2.00, Koc estimate from log Kow; IUCLID sect. 5.4.1);

HLC: 31.2 Pa*m³/mol (US EPA EPI Suite estimate, program HENRYWIN v3.20; IUCLID sect. 5.4.2);

The PNEC soil was calculated to 3.24 µg/kg ww. This value was converted to dry weight (conversion factor of 1.13) resulting in a PNEC soil of 3.67 µg/kg soil dw.

Conclusion on classification

Following GHS and in accordance with the 2ndATP (regulation EC/286/2011, section 4.1), the substance is not to be classified as hazardous to the aquatic environment since the substance was rapidly biodegraded in a Zahn-Wellens test (OECD 302B), the log Pow was < 4.0, and the estimated BCF is < 500.