Registration Dossier

Diss Factsheets

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:
1.7 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.064 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:
0.069 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

Official classification:

Aquatic compartment

In accordance with Regulation (EC) No 1272/2008, Annex VI Table 3.1, the substance is not officially classified.

In accordance with Regulation (EC) No 1272/2008, Annex VI Table 3.2, the substance is not officially classified.

 

Self-classification:

Aquatic compartment

Following CLP, the substance is not to be classified as acutely hazardous to the aquatic environment. Based on the available acute and chronic data, the substance is not to be classified as chronically hazardous to the aquatic environment.

 

Rationale:

The substance is not classified as acutely hazardous to the aquatic environment, since the lowest acute effect value is >> 1 mg/L (limit test; worst-case approach; nominal, analytically verified, Lonza Ltd: rep. no.698 -201 -0756 (daphnia, 2015) and 698 -201 -0756 (algae, 2017)).

Chronic data are available only for algae, therefore classification is based on the available chronic and acute toxicity data.

- Chronic toxicity data:

Chronic toxicity data are available for algae (72 -h ErC10 = 100 mg/L, Lonza Ltd, 2017). According to the criteria outlined in Table 4.1.0(b)(i) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008 for non-rapidly degradable substances for which adequate chronic toxicity data are not available) the substance is not to be classified as chronically hazardous to the aquatic environment.

- Acute toxicity data:

According to the available short-term toxicity data for fish and aquatic invertebrates no toxicity observed up to the highest tested concentration of 100 mg/L.  Therefore, the classification is based on the acute E(L)C50 value of 100 mg/L. The substance is not readily biodegradable (see IUCLID Ch. 5.2.1), the log Kow < 4 (log Kow = -0.49, Lonza Ltd, 2015) and the estimated BCF < 500 (max. BCF = 3.2 L/kg, see IUCLID Ch. 5.3.1). According to the criteria outlined in Table 4.1.0 (b) (iii) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272 (2008) the substance is not to be classified as chronically hazardous to the aquatic environment.

 

- Conclusion:

Based on the available acute and chronic toxicity data, the substance is not chronically hazardous to the aquatic environment.