Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
949.61 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:
453.1 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Classification is not triggered based on available data, according to REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.

Conclusion on classification

Classification of Clioquinol for effects in the environment

Several major guideline – estimation values (Klimisch 2) are available for Clioquinol, indicates no toxic effect on fish and any other tropic levels.  Thus, the value which have been considered for further calculation (fish) is LC50 = 10 mg/L.

  

In determining the classification appropriate to Clioquinol, it is necessary to consider all available evidence concerning its persistence, potential to accumulate and predicted or observed environmental fate and behavior that may present a long-term and/or delayed danger to the structure and/or functioning of aquatic ecosystems. These points are considered below.

 

Persistence

Reliable studies are available to demonstrate thatClioquinolis non persistent in nature and so is considered to have rapid biodegradation in the environment. In other wordsClioquinol degradation may therefore be expected to be fast. Thus it can be inferred thatClioquinolis non persistent in character. 

 

Clioquinol is non persistent and so do not satisfy the criteria for classification as persistent (P). 

 

Potential to accumulate

Measured log Kow values for Clioquinol is less than 4 (log Kow = 3.8). The potential for Clioquinol to bioaccumulate in the tissues of organisms that inhabit aquatic or terrestrial matrices is negligible as the BCF factor for the substance is less than 1000.  

 

 The calculated BCF of Clioquinol is 91 dimensionless and below the threshold of 2000. 

 

Clioquinol does not satisfy the criterion for classification as bioaccumulative (B).

 

The toxicity values of fish, invertebrates and algae are LC50 = 10 mg/L, NOEC = 8.449671 mg/L and NOEC = 4.034495 mg/L, respectively. The end point result values of fish indicate that the substance will have toxicity effect within the classifying range. So, the substance will qualify for classification as per the CLP regulation.  But as the BCF value of clioquinol reported was not >= 500 as well as the substance was found to be rapidly degradable.Thus considering the from CLP Criteria for aquatic classification of the substance , it is concluded that Clioquinol could not exhibit short term toxicity to fish .

So, Clioquinol does not satisfy the environmental effects criterion for classification as toxic (T).

 

Thus it can be inferred that Clioquinolneitheris P & B (including vPvB) substance, nor will qualify as T.