Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.8 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.24 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.02 µg/L
Assessment factor:
100
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:
50 µg/kg sediment dw
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
1.86 µg/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:
14.8 µg/kg soil dw
Assessment factor:
100
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

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

Additional information

Conclusion on classification

The 96-hour LC50 for fish, the 48-hour EC50 for crustacea, and the 72-hour ErC50 for algae and other aquatic plants are <1 mg/L. The chronic NOECs for fish and crustacea are <0.1 mg/L. Additionally, the substance is considered not rapidly degradable and does not meet the criteria for a potential to bioaccumulate. Based on all the available data, the test substance is classified as Acute Cat 1 (H400: Very toxic to aquatic life) and Chronic Cat 1 (H410: Very toxic to aquatic life with long lasting effects) according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

 

In accordance with article 10 of the CLP Regulation (EC) No 1272/2008, if an M-factor is not yet given in Part 3 of Annex VI to the CLP Regulation, an M-factor should be determined and a scientific justification provided, when classifying substances for Acute Category 1 or Chronic Category 1. For this substance, adequate acute aquatic data are available in fish, aquatic invertebrates, and algae. An Acute M-Factor is based on the lowest reported effects in the most sensitive species, diatom. Therefore, the M factor is 100 based on the 96 h EC/LC50 of 0.0063 mg/L in diatoms.

 

In accordance with article 10 of the CLP Regulation (EC) No 1272/2008, if an M-factor is not yet given in Part 3 of Annex VI to the CLP Regulation, an M-factor should be determined and a scientific justification provided, when classifying substances for Acute Category 1 or Chronic Category 1. Chronic data were available in fish, invertebrates, and algae. The lowest reported effects in chronic data were the 21 d NOEC data of 0.008 mg/L in aquatic invertebrate. The test substance is Not biodegradable . Therefore, the M factor is 10.