Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.11 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1.1 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.011 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.11 µg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.433 µg/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:
0.802 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

PNEC sediment(freshwater), PNEC sediment (marine waters), PNEC soil

No toxicity tests with sediment dwelling or terrestrial organisms are available. Thus, in accordance with the Guidance on information requirements and chemical safety assessment, Chapter R.10: Characterisation of dose [concentration]-response for environment, 2017, the PNEC for freshwater and marine water sediment as well as the PNEC soil have been calculated with the equilibrium partitioning method using EUSES 2.1.

 

The following data have been taken into account for calculation: 

Molecular weight (range)

280.41 - 444.61 g/mol

Melting point

6°C

Boiling point

346°C

Vapour pressure

9.0E-6 Pa at 25°C

Log Kow

2.95 (weighted mean)

LC50 fish

>0.11 mg/L (limit test)

EL50 Daphnia

8.4 mg/L

EL50 algae

0.11 mg/L

EC10 algae

0.070 mg/L

PNECaqua

0.11 µg/L

PNECaqua marine

0.011 µg/L

 

Conclusion on classification

The most sensitive organism was Pseudokirchneriella subcapitata. Thus, the lowest acute toxicity value is the 72 h ErL50 of 0.11 mg/L loading rate WAF. This value was used for the calculation of PNECs.

In accordance with Regulation EC No 1272/2008, based on these results and the substance being not rapidly biodegradable, CGE-PMDA adduct has to be classified as Aquatic Acute 1 with an M factor of 1 and Aquatic Chronic 1 with an M factor of 1.