Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
310 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
31 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.257 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:
0.335 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

12-Ketochenodeoxycholic acid (on the basis of a read-across evaluation) did not result a dangerous substance for aquatic organisms in the short-term studies performed. The lowest eco-toxicity value, the NOECof 30.64 mg/L based on algal biomass, does not involve neither an acute hazard for the aquatic environment, nor a long-term risk, because of the rapid degradation of the substance and of its low bioaccumulation potential.

Conclusion on classification

On the basis of the available data and according to Regulation 1272/2008/EC, 12-Ketochenodeoxycholic acid is not classified for environmental risks.