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
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.02 mg/L

Marine water

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

STP

Hazard assessment conclusion:
no emission to STP expected

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.009 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:
0.016 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Conclusion on classification

Classification based on biodegradation, bioaccumulation and acute aquatic data

 

Biodegradation: not readily biodegradable (EPISuite estimation)

LogPow: 3.18, 3.39 and 3.19, respectively at pH 5, 7 and 9 (EU method A.8) / 2.45 (US EPA PAG 63-11)

 

Aquatic acute toxicity

For fish: LC50(96 h) = 18 mg/L, (OECD 203, rainbow trout)

For aquatic invertebrates: EC50(48h) = 2 mg/L (OECD II A 8.3.1, Daphnia Magna)

For algae: ErC50(72 h) > 16 mg/L, (OECD 201, Pseudokirchnerella subcapitata)

 

Based on the data above, the substance is considered to be not rapidly degradable and indicates a rather low potential for bioaccumulation.

 

Classification and labelling according to Regulation (EC) No.1272/2008 (CLP):

The criteria for classification of a substance in category Acute 1 are defined on the basis of acute aquatic toxicity data only (EC50 or LC50); classification is required for values ≤ 1 mg/L. Therefore, the substance does not need to be classified for acute (short-term) aquatic hazard.

 

No chronic data as required (NOAEC) by Regulation 1272/2008 are available and hence, the result from the short-term tests have to be assessed according to the respective criteria for chronic aquatic hazard in combination with the biodegradation and bioaccumulatoin (log Pow as BCF is not available) data. In the absence of chronic data the chronic classification for Category 2 is based on acute aquatic toxicity data > 1 to ≤ 10 mg/L for daphnia (2 mg/L) and the fact that the substance is not rapidly degradable although the substance indicate a low potential of bioaccumulation.