Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
0.2 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
2 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
0.02 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
0.009 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
0.017 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
44.44 mg/kg food
Assessment factor:
90

Additional information

Appropriate long-term studies on the environmental toxicity of the test substance are not available. Following ECHA guidance R.10, the environmental PNECs were derived from the lowest L(E)C50 value observed in the available valid acute toxicity studies conducted with three species from three trophic levels. The study with freshwater algae resulted in the lowest ErC50 value of 0.2 mg/L and this concentration was used as the starting point of PNEC derivation. No studies on the toxicity to sediment-dwelling organisms or soil organisms are available. The PNECs were calculated from the respective PNECs aqua with the equilibrium partitioning method, which is applicable for substances with log Kow values between 3 and 6.

 

 

Conclusion on classification

CLP Regulation:

Aquatic acute toxicity:

Due to the ErC50 of 0.2 mg/L as derived from the algae toxicity study, Aquatic Acute Toxicity Category 1 applies (H400).

Aquatic chronic toxicity:

The only long-term study available is the algal growth inhibition study, which resulted in a NOEC of 0.06 mg/L. This would lead to a classification as Category Chronic 2 (H411) as the substance is readily biodegradable.

According to Table 4.1.0 in the 2nd Amendment of Regulation (EC) No 1272/2008, for substances for which adequate chronic toxicity data are only available for one or two trophic levels, chronic classification has to be assessed using the acute toxicity data for the other trophic levels.

Based on the acute data Aquatic Chronic Toxicity Category 1 applies if L(E)C50 < 1.0 mg/L and the substance furthermore is not rapidly degradable and/or the experimentally determined BCF≥ 500 (or, if absent, the log Kow≥ 4). As the log Kow was determined to be 4.78, and the EC50 for daphnia is 0.28 mg/L, Aquatic Chronic Toxicity Category 1 applies to the test item (H410).