Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.13 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:
0.013 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
13.05 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:
5 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

PNEC sediment using Equilibrium Partitioning Method

The formula for the PNEC sediment calculation involves the same factors in both the cases of freah-water (fs) and marine water (mw) sediments, except for the PNEC variable, which is water type related.

PNECfs/mw sed = (Ksusp-water/RHOsusp)*PNECfs/mw water*1000

Where:

PNECfresh-water Predicted No Effect Concentration in fresh-water [mg/l] 0.13
PNECmarine water Predicted No Effect Concentration in marine water [mg/l] 0.013
RHOsusp bulk density of wet suspended matter [kg/m3] 1150
Ksusp water partition coefficient suspended matter water [m3/m3] 251
PNECfs sed Predicted No Effect Concentration in sediment  [mg/kg of wet sediment]  28.37
PNECmw sed Predicted No Effect Concentration in sediment  [mg/kg of wet sediment]  2.837

Ksusp water= Fwatersusp+ Fsolidsusp*Kpsusp/1000*RHOsolid

 

Kpsusp= Focsusp*Koc

The value of Ksusp-waterof 251 is based on the representative Log Koc = 4 used for the category.

PNEC fw sediments = (251/1150)*0.13*1000 = 28.37 mg/kg wwt

PNEC mw sediments = (251/1150)*0.13*1000 = 2.837 mg/kg wwt

The PNECsfw/mw sed obtained are wet weight basis, thus the PNECs are recalculated to dry sediment using the conversion factor for sediments of 4.6; therefore, the PNEC fresh-water sediment resulted 130.5 mg/kg dw and the PNEC marine water resulted 13.05 mg/kg dw.

PNEC soil using Equilibrium Partitioning Method

The following formula is applied:

PNECsoil= (Ksoil-water/RHOsoil)*PNECwater*1000

Where:

PNECfresh-water Predicted No Effect Concentration in fresh-water [mg/l] 0.13
RHOsusp bulk density of soil [kg/m3] 1700
Ksoil water partition coefficient soil water [m3/m3] 300
PNECsoil Predicted No Effect Concentration in soil [mg/kg of wet sediment]  22.94

Ksoil water= Fairsoil*Kair-waterl+Fwatersoil+ Fsolidsoil*Kpsoil/1000*RHOsolid

Kpsoil= Focsoil*Koc

PNEC soil = (300/1700)*0.13*1000 = 22.94 mg/kg wt

The PNEC sediment obtained is wet weight basis, thus the PNEC has been recalculated to dry sediment using the conversion factor for sediments of 1.13; therefore the PNEC soil resulted 25.92 mg/kg dw.

The most conservative PNEC soil value of 5 mg/kg dw based on the acute experimental tests has been selected for Risk Assessment.

Conclusion on classification

Biodegradation in water: not rapidly biodegradable

Log Kow < 0 (non bioaccumulative)

Acute toxicity:

- to Fish: LC50 (96h) > 100 mg/l

- to Algae ErC50 (72h) >100 mg/l

- to Crustacean EC50 (48h) > 100 mg/l

 Chronic toxicity:

- to Crustacean NOEC (21d) = 6.59 mg/l

 

Classification justification according to CLP

Based on the data above, CAS 13863-31-5 is determined to be not rapidly degradable. No acute aquatic toxicity was observed. Valid chronic toxicity data are available for Daphnia – NOEC (21 d) > 1 mg/l. Therefore CAS 13863-31-5 is not classified for the environment according to the Regulation (EC) No.1272/2008 (CLP) and the Regulation (EU) No. 286/2011 (2nd ATP).