Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.714 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
10 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.071 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.259 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:
0.1 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

PNECs are based on the following data for the test substance:

Test type

Results

Microorganisms, activated sludge

28 d NOEC toxicity control: 28.57 mg a.i./L

Short-term studies

 

Daphnia magna

48h-EC50: >1000 mg a.i./L

Oncorhynchus mykiss

96h-LC50: >1000 mg a.i./L

Pseudokirchneriella subcapitata (old name: selenastrum capricornutum)

72h-ErC50: >1000 mg/L

Chronic studies

 

Pseudokirchneriella subcapitata  

(old name: selenastrum capricornutum)

72h-NOErC: 1000 mg/L 

Daphnia magna

21d-NOEC biomass: 7.14 mg/L

No tests were performed with sediment organisms or terrestrial organisms. The PNECs for those compartments were derived using the equilibrium partitioning theory and log Koc. All relevant substance characteristics were entered into EUSES version 2.1.2 to produce PNECsediment for the freshwater and marine compartment as wel as PNECsoil.

Conclusion on classification

The substance is not classified as hazardous to the aquatic environment.

Acute (short-term) aquatic hazard

Acute toxicity (E(L)C50 values) data for fish, crustacea and algae are all >1 mg/L. Therefore the substance needs no classification with Category Acute 1.

Long-term aquatic hazard

Acute toxicity data (E(L)C50 values) are available for fish, crustacea and algae and are > 1000 mg/L. Reliable chronic toxicity data are available for crustacea and algae with chronic NOEC values >1 mg/L. Further chronic fish testing has been waived to avoid unnecessary animal testing. Therefore additional information from a chronic fish test is not expected to alter the proposal not to classify the substance as hazardous to the aquatic environment. In addition the substance is readily biodegradable and the bioaccumulation potential of the substance is low given the log Kow of -1.8. As the chronic toxicity is > 1 mg/L, the substance does not meet the criteria for classification with Categories Chronic 1, 2 or 3 nor with the criteria for classification with R50/53, R51/53 or R52/53.

Safety net classification

The safety net classification does not apply. The substance is readily biodegradable and information on bioaccumulation is not available, but the low log Kow suggests a lack of bioaccumulation potential. In addition all chronic EC10/NOEC values are >1 mg/l. Therefore the substance needs no classification as Chronic Category 4.

Conclusion

Based on the results from the acute aquatic toxicity (E(L)C50 values >1000 mg/L) and chronic aquatic toxicity (EC10/NOEC > 1 mg/l) and based on the fact that the substance has a low bioaccumulation potential and is rapidly biodegradable, the substance is not classified as hazardous to the environment according to Directive 67/548/EEC and according to the CLP Regulation 1272/2008.