Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.033 mg/L
Assessment factor:
250
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.473 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.003 mg/L
Assessment factor:
2 500
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.014 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:
0.009 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

Classification based on biodegradation, bioaccumulation, acute and chronic data

Biodegradation:      10% within 28 d (OECD 301F)

LogKow:                  0.8 (flask method; value from peer-reviewed database)

Aquatic acute toxicity

For fish: LC50(96 h) = 71 mg/L, (OECD 203, Oncorrhynchus mykiss)

For algae: ErC50(72 h) = 120 mg/L, (OECD 201, Desmodesmus subspicatus)

Aquatic chronic toxicity

For aquatic invertebrates: NOEC(21 d) = 21 mg/L (OECD 211, Daphnia magna)

Based on the data above, the substance is considered to be not rapidly degradable and indicates a 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.

In cases like the present one, where chronic data is available, but not for all three trophic levels, both - acute and chronic data - have to be assessed according to the respective criteria for chronic aquatic hazard and the substance should be classified according to the most stringent outcome:

- Classification of a non-rapidly degradable substance, for which there are adequate chronic toxicity data available, in category Chronic 1 is required for chronic NOEC or ECx ≤ 0.1 mg/L (Chronic 2: > 0.1 to ≤ 1 mg/L).

- In the absence of chronic data the chronic classification for Category 3 is based on acute aquatic toxicity data > 10 to ≤ 100 mg/L for fish and because the substance is not rapidly degradable although the substance indicate a low potential of bioaccumulation.

Hence, although classification for chronic aquatic hazard would not be necessary based on the available long-term data only, it has to be classified with Category Chronic 3 based on the available short-term data [LC50 (96h, fish) =71 mg/L] combined with degradation data (most stringent outcome of assessment).