Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

Sediment (freshwater)

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

Sediment (marine water)

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

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.88 mg/kg soil dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for predators

Additional information

The aquatic toxicity of quinidine to invertebrates was determined experimentally and published by Lilius, 1994. The EC50 of quinidine sulphate for Daphnia magna was determined according to OECD guideline in freshwater. The EC50 (24 h) for Daphnia magna is 44.81 mg/l. According to this, the EC50 of quinidine is 34.4 mg/L. Additionally in an own study, the EC50 of the read-across substance quinidine sulphate was determined for Daphnia magna in fresh water for 48 h. The EC50 of quinidine sulphate is 46.7 mg/L. According to this, the EC50 of quinidine is 40.57 mg/l. The aquatic toxicity to algae was also determined experimentally and published by Carrieri, 2007. In this publication, the toxicity to cyanobacterium Arthrospira maxima was determined with a quantum efficiency test. The LC100 of quinidine is ca. 400 µM (129.77 mg/L) and the LC50 of quinidine is >200 µM (64.88 mg/L). For PNEC calculation most-sensitive endpoint was used. For PNECwater Streptocephalus proboscideus with a LC50 of 3.56 mg/L and for PNECsoil Lactuca sativa with a IC50 of 0.88 g/kg were used.

Conclusion on classification

The experimentally determined LC50/EC50 of quinidine for fish, invertebrates and algae is > 10 mg/L and furthermore quinidine is readily biodegradable. According to CLP 1272/2008 criteria for acute (short-term) aquatic toxicity, only substance with a toxicity of LC50/EC50 <1 mg/L has to be classified. Therefore, quinidine is not harmful to aquatic life and does not need to be classified.