Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
1.05 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:
2.1 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

PNEC freshwater sediment:

K_(susp-water) = 1650

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6  

 

 

PNEC_freshwater sediment

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

= (1650/1150)* 0.00159 *1000

= 2.28 mg/kg wwt

= 10.5 mg/kg dwt

 

PNEC marine water sediment:

K_(susp-water) = 1650

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6

 

PNEC_marine water sediment

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

= (1650/1150)*0.000159* 1000

= 0.228 mg/kg wwt

= 1.05 mg/kg dwt

 

PNEC soil:

K_(soil-water) = 1980

RHO_(soil) = 1700

Conversion factor (wwt -> dwt): 1.13

 

PNEC_soil

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

= (1980/1700)* 0.00159* 1000

= 1.85 mg/kg wwt

= 2.1 mg/kg dwt

Conclusion on classification

Acute toxicity:

The Daphnia is the most sensitive species with a EC50 value of 1.59 mg/L. According to Directive 67/548/EEC and Regulation (EC) No 1272/2008 (CLP, GHS) the test substance has not to be classified regarding acute toxicity to the environment as the lowest LC50 value is above 1 mg/L.

Chronic toxicity:

The Daphnia is the most sensitive species with an EC50 value of 1.59 mg/L. For derivation of classification and labelling also the algae 72 -h EC10 value based on growth rate was determined as 1.55 mg/L has to be taken into account. In biodegradation studies on the symmetrical epoxy amine adducts, according to EU method C.4–E, no biodegradation was observed. Based on the read-across approach Reaction Product of Bisphenol A diglycidylether (BADGE) with IPDA and MXDA was considered not ready biodegradable. As a result the substance has to be classified as env. Chronic toxic cat 2, H411 according to Regulation (EC) No 1272/2008 (CLP/GHS), as amended for the sixth time in Regulation EC 1297/2014. The substance has to be classified with N, R51/R53 under Directive 67/548/EEC.