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:
3 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-water of 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 PNECs fw/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 3 mg/kg dw based on the acute experimental tests has been selected for Risk Assessment.

Conclusion on classification

The available experimental data are adequate for the evaluation of the classification and labelling according to the CLP Regulation EC 1272/2008 and related amendments.

Biodegradation in water: not rapidly biodegradable

Log Kow: < 0 (non bioaccumulative)

 

Acute toxicity:

- to fish: LC50 (96h) > 1000 mg/l

- to Algae EC50 (72h) >100 mg/l

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

 

Chronic toxicity:

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

 

Based on the data above, CAS 16324-27-9 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, no classification for CAS 16324-27-9 according to the Regulation (EC) No.1272/2008 (CLP) and the Regulation (EU) No. 286/2011 (2nd ATP).