Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.028 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:
0.048 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

PNEC calculation is done based on the acute data from the registered substance only as a worst case. Nevertheless, data with the hydrolysis product methacrylic acid and the structurally related methyl methacrylate together with the ready biodegradability of the registered substance show the lack of any adverse toxic chronic effects.

PNEC calculation PNEC freshwater sediment:

K_(susp-water) = 5.55 m3/m3

RHO_(susp) = 1150 kg/m3

Conversion factor (wwt -> dwt): 4.6  

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

= (5.55/1150)* 0.013 *1000

= 0.06 mg/kg wwt

= 0.28 mg/kg dwt  

 

PNEC marine water sediment:

K_(susp-water) = 5.55 m3/m3

RHO_(susp) = 1150 kg/m3

Conversion factor (wwt -> dwt): 4.6  

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

= (5.55/1150)* 0.0013 * 1000

= 0.006 mg/kg wwt

= 0.028 mg/kg dwt  

 

PNEC soil:

K_(soil-water) = 5.78 m3/m3

RHO_(soil) = 1700 kg/m3

Conversion factor (wwt -> dwt): 1.13  

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

= (5.78/1700)* 0.013 * 1000

= 0.04 mg/kg wwt

= 0.048 mg/kg dwt

Conclusion on classification

Aquatic acute toxicity

Algae: 72 h, ErC50: 12.5 mg/L (nominal)

Fish: 96 h, LC50: 590 mg/L (nominal)

Daphnia magna: 48 h, EC50 growth rate: 33.9 mg/L (measured)

 

Aquatic chronic toxicity

Fish: 35 d, NOEC: 9.4 mg/L (measured, read-across substance)

Daphnia magna : 21 d, NOEC (reproduction): 37 mg/L (measured, read-across substance)

 

 

Biodegradation: readily biodegradable

Partition coefficient: log Pow = 3.13 at 25°C 

 

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 substance was found to be readily biodegradable. Algae represent the most sensitive species among the three trophic levels in aquatic toxicity testing, with an ErC50 of 12.5 mg/L and an ErC10 of 5.49 mg/L. Based on these results, the substance is neither classified as aquatic acute toxicity nor classified as aquatic chronic according to Regulation (EC) No 1272/2008 (CLP) as amended for the tenth time in Commission Regulation (EU) No 2017/776.