Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
19 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:
36.6 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Relevant data used for calculation of PNECs

 

Short-term toxicity to fish

96 h LC50 = 4.2 mg/L

Short-term toxicity to aquatic invertebrates

48 h EC50 = 2.5 mg/L

Toxicity to algae

72 hr ErC50 = 2.40 (2.28 – 2.54) mg a.i./L;

72 hr ErC10 =0.494 (0.437 – 0.557) mg a.i./L

 

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, 2008, 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

ca. 380 g/mol (C12) – ca. 440 g/mol (C18)

Melting point

no melting point identified

Vapour pressure

8E-21 Pa at 25°C

(Set to minimum value of 1E-06 in EUSES)

Water solubility

400 g/L at 20°C

Log Kow

3.43 at 23.7°C

PNEC Aqua(freshwater)

2.4 µg/L

PNEC Aqua(marine water)

0.24 µg/L

 

The calculation resulted in a PNEC sediment(freshwater) of 190 µg/kg sediment dw, a PNEC sediment (marine waters) of 19 µg/kg sediment dw and a PNEC soil of 36.6 µg/kg soil dw.

Conclusion on classification

Based on acute toxicity values >1 mg/L, no classification for aquatic acute toxicity is required according to GHS Regulation EC No 1272/2008.

Chronic toxicity values between 0.1 and 1 mg/L were obtained with algae, and the substance is readily biodegradable. Thus, according to GHS Regulation EC No 1272/2008, Amphopropionates C12-18 is classified as Aquatic Chronic 3.