Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.22 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.022 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.1 mg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.089 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:
10 mg/kg soil dw
Assessment factor:
50
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Justification for classification

Brief description of the data relevant for classification

Degradation

Biodegradation: not readily biodegradable: -33.7% based on DOC removal (OECD 301 A), but degradable in soil with a half-life of 1.5 - 3.3 d

Bioaccumulation

Partition coefficient: log Pow < -2.2 at 21 °C, pH = 6

Aquatic acute toxicity

For fish (Oncorhynchus mykiss): LC50 (96 h) > 100 mg/L

For aquatic invertebrates (Daphnia magna): EC50 (48 h) > 100 mg/L

For algae/aquatic plants (Pseudokirchneriella subcapitata): EC50 (72 h) > 100 mg/L

Aquatic chronic toxicity

For fish: no data available

For aquatic invertebrates (Daphnia magna): NOEC (21 d) 11.1 mg/L

For algae/aquatic plant (Pseudokirchneriella subcapitata): NOEC (72 h) >= 100 mg/L

 

Conclusion on classification

CLP:

The acute aquatic toxicity L(E)C50 values are > 100 mg/L for fish, invertebrates and algae. Therefore, Reaction mass of 2-(3,4-dimethyl-1H-pyrazol-1-yl)succinic acid and 2-(4,5-dimethyl-1H-pyrazol-1-yl)succinic acid does not meet the criteria for classification and labelling as acute aquatic hazard the consolidated version of the Regulation (EC) No. 1272/2008 (CLP).

Valid chronic toxicity data are available for algae and invertebrates. The NOEC values are clearly above 1 mg/L. Therefore, Reaction mass of 2-(3,4-dimethyl-1H-pyrazol-1-yl)succinic acid and 2-(4,5-dimethyl-1H-pyrazol-1-yl)succinic acid does not meet the criteria for classification and labelling as long-term aquatic hazard according to the consolidated version of the Regulation (EC) No. 1272/2008 (CLP).