Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.028 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:
0.047 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
55 mg/kg food
Assessment factor:
30

Additional information

Valid data on the short-term toxicity to fish, crustacea and algae are available as tabulated below. The data indicate that the toxicity is moderate to each of the tested aquatic organisms.

Endpoint

Organism

Species

Value
[mg/L]

Reliability

96 hr LC50

fish

Leuciscus idus melanotus; Golden orfe

17.1

1

96 hr LC50

fish

Pimephales promelas;

Fathead minnow

28.2

1

48 hr EC50

crustacea

Daphnia magna

39

1

72 h EC50

algae

Scenedesmus subspicatus. (growth rate)

16.6

1

As there is no long-term NOEC for any of the taxonomic groups, an assessment factor of 1000 is to be used to derive the PNEC (aquatic) according to Reference Technical Guidance Document (Part C: reference p-TGD) dated 2005 -07 -28, section 4.4.

The lowest EC50 was 16.6 mg/L in algae (growth rate); therefore the derived PNEC (aquat) is 0.017 mg/L.

Conclusion on classification

Relevant EC50/LC50 values for acute aquatic toxicity are in the range between 10 and 100 mg/l. As the substance is readily biodegradable and shows no signs of bioaccumulation the substance does not fulfil the criteria for a classification as hazardous to the aquatic environment over short or long-term (Cat 1 to 4).