Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.064 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.475 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.006 µg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
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
PNEC value:
0.32 mg/kg soil dw
Assessment factor:
50
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

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

Additional information

Conclusion on classification

Short-term aquatic toxicity data are available for three trophic levels (fish, invertebrates and algae). The acute effect values for fish (Oncorhynchus mykiss), daphnids (Daphnia magna) and algae (Pseudokirchneriella subcapitata) are 0.23 mg/L, 0.24 mg/L and 0.0475 mg/L, respectively. The substance needs to be classified as Aquatic Acute 1 (H400), with an M-factor of 10.

Long-term aquatic toxicity data are available for aquatic invertebrates and algae. The chronic NOEC value for daphnids was determined to be 3.2 µg/L and the chronic ErC10 value for algae was determined to be 47.4 µg/L. The substance is not readily biodegradable. Based on this data, the substance needs to be classified as Aquatic Chronic 1 (H410) with an M-factor of 10.

 

As only two reliable long-term toxicity endpoint is available, chronic classification needs to be based on both chronic and acute data of which the most stringent outcome is used for the final classification. Regarding acute data (lowest acute value <1 mg/L) and the substance being not readily biodegradable, the substance needs to be classified as Aquatic Chronic 1 with an M-factor of 10 (the resulting M-factor derived for acute aquatic hazard classification is also applied to the long-term aquatic hazard classification as Table 4.1.0 (a)(b, point iii) is used here for defining long-term aquatic hazard (Guidance on the Application of the CLP Criteria, v5.0, July 2017)).

In conclusion, the substance is classified as Aquatic Chronic 1 (H410) with an M-factor of 10, as in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.