Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.014 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:
0.011 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The PNEC derivation was as follows justified:

PNEC freshwater sediment:

K_(susp-water) = 1.2

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6

PNEC_freshwater sediment

= (K_(susp-water)/ RHO_(susp))*PNEC_water * 1000

= (1.2/1150)* 30.16E-03 *1000

= 0.031 mg/kg wwt

= 0.144 mg/kg dw

 

PNEC marine water sediment:

K_(susp-water) = 1.2

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6

PNEC_marine water sediment

= (K_(susp-water)/ RHO_(susp))*PNEC_marine water* 1000

= (1.2/1150)*30.16E-04* 1000

= 0.0031 mg/kg wwt

= 0.0144 mg/kg dw

 

PNEC soil:

K_(soil-water) = 0.554

RHO_(soil) = 1700

Conversion factor (wwt -> dwt): 1.13

PNEC_soil

= (K_(soil-water)/ RHO_(soil))*PNEC_freshwater* 1000

= (0.554/1700)*30.16E-03* 1000

= 0.009 mg/kg wwt

= 0.011 mg/kg dw

Conclusion on classification

 

Dangerous Substance Directive (67/548/EEC):

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. The test surrogate substance 3-aminopropyldiethylamine is ready biodegradable. Based on the available study data on acute aquatic toxicity and data on chronic toxicity of the read across substance was the short-term toxicity to aquatic invertebrates the most sensitive test for the aquatic compartment. This study revealed a 48h-EC50 of 30.16 mg/L. In addition to this, the test for the toxicity to algae and cyanobacteria revealed an EC10 of 19.53 mg/L. Based on these results, the test item is not classified according to Directive 67/548/EEC (DSD) as amended for the 31st time in Regulation 2009/2/EEC.

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008:

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The test surrogate substance 3-aminopropyldiethylamine is ready biodegradable. Based on the available study data on acute aquatic toxicity and data on chronic toxicity of the read across substance the short-term toxicity to aquatic invertebrates was the most sensitive test for the aquatic compartment. This study revealed a 48h-EC50 of 30.16 mg/L. In addition to this, the test for the toxicity to algae and cyanobacteria revealed an EC10 of 19.53 mg/L. Based on these results, the test item is not classified according to the Regulation (EC) No 1272/2008 as amended for the sixth time in Directive EC 605/2014.