Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.011 mg/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:
0.256 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.043 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:
0.074 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

The substance meets classification criteria under Regulation (EC) No 1272/2008 as hazardous to the aquatic environment: Chronic Category 3 : H412

 

The test item is ‘readily biodegradable’ (10-day window does not apply, OECD 2006).

The test item has a measured log Kow > 4.0 although information on structural analogues indicates a Bioconcentration Factor (BCF) is considered < 500 L/wt

The test item does not indicate EC50/LC50 < 1 mg/L

However, there is a relevant EC10 (algae) or NOEC (algae) < 1 mg/L in available studies.

 

Daphnia EC50-48h = 1.3 mg/L (95% CL: 0.90 – 2.0 mg/L) based on TWA concentrations, 48-hour, freshwater, OECD 202, 2014

EC50-72h (Read-Across: undec-10-enal ; aquatic algae; growth rate) = 1.1 mg/L (C.I. 0.63 -1.3 mg/L), 72 hour, freshwater, OECD 201, 2013

NOEC (Read-across: undec-10-enal ; aquatic algae; growth rate) = 0.34 mg/L, 72 hour, freshwater, OECD 201, 2013

QSAR: Fish LC50-96h = 1.3 mg/L, iSafeRat® HA-QSAR toolbox v2.4, KREATIS SAS, 2018

Toxicity to microbes:

ASRIT: EC50-3h = 200 mg/L (nominal), 20 °C, OECD TG 209, 2018

ASRIT: EC20-3h = 130 mg/L (nominal), 20°C, OECD TG 209, 2018

ASRIT: EC10-3h = 100 mg/L (nominal), 20°C, OECD TG 209, 2018

ASRIT: NOEC = 125 mg/L (nominal), 20 °C, OECD TG 209, 2018

References:

1. ECHA Guidance on Application on the CLP Criteria, (v5.0, July 2017)