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):
1 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
PNEC marine water (intermittent releases):
1 mg/L

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
20.5 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

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 aquatic invertebrates (Daphnia) and algae:

Invertebrates (Daphnia): EC0 (48h) > 100 mg/L

Algae: EC50 (72h, growth rate) > 100 mg/L

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

Both for algae and Daphnia the EC50 is > 100 mg/L. According to Table 4.1.0 (a) the substance should not be classified for acute aquatic hazard, as the EC50 value 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 rapidly biodegradable, hence Table 4.1.0 (b) (ii) applies.

The EC10 (72h, growth rate) for algae was 58 mg/L, which is more than the cut-off value for classification 0.1 mg/L Therefore, the substance should not be classified as Chronic aquatic toxic.

Table 4.1.0 (b) (iii):

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

Invertebrates (Daphnia) EC50 (48h) > 100 mg/L

Algae (96h) EC50 > 100 mg/L (based on growth rate)

Log Kow = -3.32

The substance is readily biodegradable.

Based on the criteria Table 4.1.0 (b) (iii), the substance should not be classified as the log Kow is below 4, the substance is rapidly biodegradable and the EC50 values are above the cut-off value for classification of 100 mg/L.

Most stringent classification:

The conclusion of both assessment is that the substance should not be classified for chronic aquatic hazard.