Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.003 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.005 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.001

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.102 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:
10 mg/kg soil dw
Assessment factor:
100
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Classification related key information

Biodegradation in water: under test conditions no biodegradation observed

Bioaccumulation in organisms is negligible, based on the calculated log Pow of -3.67

 

Acute toxicity:

- to Fish: LC50 (96h) = 100 mg/L (nominal)

- to aquatic invertebrates: EC50 (48h) = 2.2 mg/L (nominal)

- to Algae: ErC50 (72h) = 0.5 mg/L (nominal)

 

Chronic toxicity:

- to aquatic invertebrates: EC10 (21d) = 1.9 mg/L (nominal; read-across)

- to Algae: NOEC (72h) = 0.16 mg/L (nominal)

 

Classification justification according to CLP

According to the data listed above Amines, polyethylenepoly (PEPA) is not readily or inherently biodegradable. The acute aquatic toxicity L(E)C50 is < 1 mg/L. The chronic NOEC is < 1 mg/L. Based on the available data the self-classification for Amines, polyethylenepoly would be Acute Cat1 and Chronic 2 according to the consolidated version of Regulation (EC) No 1272/2008 (date: 01.01.2017) and further amendments (ATPs). Amines, polyethylenepoly (PEPA) is listed on Annex VI to CLP (in force from 1 December 2018). The harmonised classification and labelling is Acute Cat. 1 and Chronic Cat. 1 according to Annex VI to CLP.

 

M-factor for acute aquatic toxicity: 1

M-factor for chronic aquatic toxicity: no factor assigned