Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.038 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.381 mg/L

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.071 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:
0.119 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 was done according to the criteria described in the CLP regulation EC No 1272/2008, version 2016.

Classification related key information

- Biodegradation: readily biodegradable: 100% after 28 days (OECD 301 F)

- Bioaccumulation: log Pow = 2.0 (OECD 117)

Aquatic acute toxicity

- Aquatic invertebrates: EC50 (48 h) >100 mg/L (Daphnia magna, OECD 202)

- Algae: ErC50 (72 h) = 38.1 mg/L (Pseudokirchneriella subcapitata, OECD 201)

- Fish: LC50 (96 h) >38 mg/L

The lowest L(E)C50 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 (72 h) for algae = 38.1 mg/L, is larger than the cut-off for classification of 1 mg/L.

Aquatic chronic toxicity

- Algae: ErC10 (72 h) = 19.2 mg/L (Pseudokirchneriella subcapitata, OECD 201)

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 readily biodegradable, hence Table 4.1.0 (b) (ii) applies.

The 72 h ErC10 value for algae was 19.2 mg/L. Therefore, the substance should not be classified for chronic aquatic hazard.

Table 4.1.0 (b) (iii):

The substance is readily biodegradable, the substance does not meet the criteria for classification for chronic aquatic hazard.

Most stringent classification:

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