Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0 mg/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:
0.002 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

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

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
1.67 mg/kg food
Assessment factor:
300

Additional information

Conclusion on classification

Aquatic acute toxicity

48 h, EC50 (Daphnia magna) = 0.045 mg/L (measured)

72 h, ErC50 ( Pseudokirchneriella subcapitata) = 0.640 mg/L

96 h, LC50 (Oncorhynchus mykiss) > 0.0241 mg/L (measured) = 0.045 mg/L (nominal)

Aquatic chronic toxicity

72 h, ErC10 ( Pseudokirchneriella subcapitata) = 0.114 mg/L (measured)

Biodegradation

not readily biodegradable

Partition coefficient

log Pow = 4.3 at 25 °C

Acute aquatic hazard: Category Acute 1, M-factor: 10. H400: Very toxic to aquatic life

Long-term aquatic hazard: Category Chronic 10, M-factor: 1. H410: Very toxic to aquatic life with long lasting effects

Reasoning:

Acute aquatic hazard:

Most sensitive species Daphnia magna

Acute toxicity EC50 ≤ 1 mg/l. M-factor based on EC50 between 0.01 and 0.1 mg/l.

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.

In cases where the chronic data do not represent the species that is considered the most sensitive in available short-term tests, the classification and M-factor should be based on the data (acute or chronic) that gives the most stringent outcome.

Therefore, acute toxicity data were taken into account for classification instead chronic toxicity data (ErC10 value).

The test item is classified as aquatic chronic category 1 based on an EC50 value of 0.045 mg/L (measured) of the most sensitive species (Daphnia).

M-factor derived for acute aquatic hazard classification is also applied to the long-term aquatic hazard classification.