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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.046 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:
0.033 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 and acute aquatic data

 

Biodegradation

Not readily biodegradable: no degradation observed (DOC) (OECD 301E, EU method C.4-B, GLP)

LogKow: <-2

Water solubility = 1280 g/l

 

Aquatic acute toxicity

For fish: LC50(96h) > 1000 mg/l, NOEC(96h) = 1000 mg/l, for trouts, (read-across from PPS, OECD 203, static, GLP)

For aquatic invertebrates: EC50(48h) > 1000 mg/l, NOEC(48h) = 1000 mg/l, based on immobilization, for Daphnia magna (OECD 202, EU method C.2, GLP)

EC50(48h) > 100 mg/l, NOEC(48h) = 100 mg/l, based on immobilization, for Daphnia magna (read-across from PPS, OECD 202, EU method C.2, GLP)

For algae: ErC50(72h) >100 mg/L, (OECD 201)

 

Based on the data above, the substance is considered to be 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.

 

No chronic data 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 bioaccumulation (log Pow as for this tonnage band BCF is not available) data; classification would be required as follows:

 

Category Chronic 1

96 hr LC50 (for fish) ≤1 mg/L and/or

48 hr EC50 (for crustacea) ≤1 mg/L and/or

72 or 96 hr ErC50 (for algae or other aquatic plants) ≤1 mg/L

and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log Kow ≥ 4).

 

Category Chronic 2

96 hr LC50 (for fish) >1 to ≤10 mg/L and/or

48 hr EC50 (for crustacea) >1 to ≤10 mg/L and/or

72 or 96 hr ErC50 (for algae or other aquatic plants) >1 to ≤10 mg/L

and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log Kow ≥ 4).

 

Category Chronic 3

96 hr LC50 (for fish) > 10 to ≤ 100 mg/L and/or

48 hr EC50 (for crustacea) > 10 to ≤ 100 mg/L and/or

72 or 96 hr ErC50 (for algae or other aquatic plants) > 10 to ≤ 100 mg/L

and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log Kow ≥ 4).

 

Category Chronic 4

Cases when data do not allow classification under the above criteria but there are nevertheless some grounds for concern. This includes, for example, poorly soluble substances for which no acute toxicity is recorded at levels up to the water solubility (note 4), and which are not rapidly degradable in accordance with section 4.1.2.9.5 and have an experimentally determined BCF ≥ 500 (or, if absent, a log Kow ≥ 4), indicating a potential to bioaccumulate,

 

Taking into account only the results from aquatic toxicity testing, no classification is triggered, as the lowest EC50 is > 100 mg/l (algae, 72h).