Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.01 mg/L
Assessment factor:
10 000
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:
0.392 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.039 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:
0.02 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

According to the CLP Regulation (EC n. 1272/2008) the classification for aquatic acute toxicity follows the Table 4.1.0 a.

A substance has to be classified as Aquatic Acute 1 when:

96 hr LC50 (for fish) ≤ 1 mg/l and/or

48 hr EC50 (for crustacea) ≤ 1 mg/l and/or

72 or 96 hr ErC50 (for algae or other aquatic plants) ≤ 1 mg/l.

 

According to the CLP Regulation when the substance is rapidly biodegradable and no adequate chronic toxicity data are available, the classification criteria would be those reported into the Table 4.1.0 (a). The short-term toxicity values recorded in all the organisms tested are outside of the classification thresholds, thus the substance does not meet the criteria to be classified for aquatic acute toxicity.

In the light of a conservative approach, an assessment of similar registered substances to the target substance was performed, in order to reduce the uncertainty regarding its ecotoxicological behavior and to conclude a classification under the CLP Regulation for the environmental hazard class as reliable as possible. As described in detail in the read across justification document (IUCLID section 13), none of these evaluated substances is classified under the CLP Regulation for environmental hazard class. The adequacy of the performed comparison was determined to be reliable, based on the equal toxicity level on invertebrates, structural similarity, same mode of action (i.e. baseline toxicity), similar physicochemical properties across the target and the similar substances.

Considering, in a weight of evidence approach, the available data on the substance in itself, on the Parent Substance #1 and on the evaluated similar substances, the target substance was confirmed to be as not classified under the CLP Regulation (EC 1272/2008) for both acute and chronic aquatic toxicity.