Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.002 mg/L
Assessment factor:
1 000
PNEC freshwater (intermittent releases):
0.019 mg/L

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

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

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
14.2 mg/kg soil dw

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
16.7 mg/kg food
Assessment factor:
300

Additional information

PNEC values were calculated on the basis of the observation and effects seen in the three eco-toxicology studies where the water solubility values were analytically determined. Those water solubility values differ, in some cases, from that determined in the water solubility test of a 10 fold. Hence this approach is going to over-estimate the environmental distribution in the water compartment. Additional QSAR modeling with ECOSAR confirms that the substance will not result in chronic toxicity at the limits of water solubility.

As already discussed chemicals of concern regarding the secondary poisoning include lipophilic organic chemical and some metal compounds. Secondary poisoning is concerned with toxic effect in the higher members of the food chain (living in aquatic or terrestrial compartments) which result from ingestion of organisms from lower trophic levels that contain accumulated substances. The substance is not expected to be highly lipophilic and it is not considered bioaccumulative for purposes of CLP classification. Its calculated PNEC oral for secondary poisoning is considered high enough and not leading to any risk.

Conclusion on classification

The substance does not cause toxicity at the limits of water solubility and therefore is not classified as harmful to the environment for CLP regulation purposes.