Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
3.33 ng/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
33.3 ng/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.33 ng/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
33.3 ng/L

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:
0.007 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.001 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:
0.001 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Conclusion on classification

Aquatic acute toxicity

48 h, EC50 (Daphnia magna) = 11.115 mg/L (nominal loading rate) = 3.33 µg/L (estimated concentration based on measured concentration)

72 h, ErC50 ( Pseudokirchneriella subcapitata) > 100 mg/L (nominal)

96 h, LC50 (Oncorhynchus mykiss) > 100 mg/L (nominal)

Aquatic chronic toxicity

72 h, ErC10 ( Pseudokirchneriella subcapitata) = 91.9 mg/L

Biodegradation

not readily biodegradable

Partition coefficient

log Pow = 5.5 at 25 °C

Acute aquatic hazard: Category Acute 1

Long-term aquatic hazard: Category Chronic 1

M-factor: 100 (for acute and chronic)

Reasoning:

Acute aquatic hazard:

Acute aquatic toxicity data for daphnia (48 h, OECD 202), L(E)C50 </= 1 mg/L, results in Acute 1

Long-term aquatic hazard:

The criteria for classification of a substance into the categories Chronic 1 to 3 follow a tiered approach where the first step is to see if adequate information on long-term toxicity is available allowing long-term hazard classification. Using the surrogate system, considering the lowest acute aquatic toxicity data for daphnia (48 h, OECD 202), L(E)C50 =/< 1 mg/L, with "not ready biodegradable" and log Kow > 4, results in Chronic 1 which is the most stringent outcome.

M-factor

Since the conclusion is based on the surrogate system the M-factor is based on the acute aquatic toxicity between 0.001 and 0.01 mg/l.