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):
0.016 mg/L

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.001 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:
0.001 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

In order to determine the classification for hazardous properties related to the aquatic environment, the criteria of the Regulation (EC) No 1272/2008 (CLP) version 2016 in Annex I were accurately followed.

Short-term (acute) aquatic hazard:

For classification, acute toxicity data are available for fish, aquatic invertebrates (Daphnia) and algae:

Fish: LC50 (96h) = 25.7 mg/L

Daphnia: EC50 (48h) = 10.7 mg/L

Algae: EC50 (72h, growth rate) = 1.56 mg/L

The criteria in Table 4.1.0 (a) of Annex I of the CLP Regulation were applied.

The lowest EC50 value was observed for algae, which is hence the most sensitive species. According to Table 4.1.0 (a) the substance should not be classified for acute aquatic hazard, as the lowest EC50 value, EC50 (72, growth rate) for algae = 1.56 mg/L, is larger than the cut-off for classification of 1 mg/L.

Long-term (chronic) aquatic hazard:

For chronic classification, there are only chronic data available for one trophic level: algae. As described in Figure 4.1.1 in the CLP regulation (EC No 1272/2008, version 2016), the most stringent outcome of classification according to Table 4.1.0 (b) (i) or (ii) and (iii) should be used.

Table 4.1.0 (b) (ii):

The substance is not readily biodegradable, hence Table 4.1.0 (b) (i) applies.

The EC10 (72h, growth rate) for algae was 0.841 mg/L, which is < 1 mg/L but > 0.1 mg/L. Therefore, the substance should be classified as Chronic aquatic toxic category 2.

Table 4.1.0 (b) (iii):

Classification based on available acute data available for 2 trophic levels and environmental fate data:

Fish: LC50 (96h) 25.7 mg/L

Daphnia (48h) EC50 = 10.7 mg/L

Log Kow = 0.62

The substance is not readily biodegradable

Based on the criteria Table 4.1.0 (b) (iii), the substance should be classified as chronic category 3 as the substance is not readily biodegradable and the lowest EC50 value (Daphnia EC50 (48h) = 10.7 mg/L) is > 10 and ≤ 100 mg/L.

Most stringent classification:

The conclusion of both assessments is that the substance should be classified for chronic aquatic hazard, category 2.