Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.256 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.118 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.026 mg/L
Assessment factor:
100
PNEC marine water (intermittent releases):
0.012 mg/L

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
177 mg/L
Assessment factor:
1
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.101 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:
0.052 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The reported acute toxicity data for MEKO in fish and Daphnia show values greater than 100 mg/L. Algae are the most sensitive to MEKO with a reported LC50 value for growth rate of 11.8 mg and a NOEC of 2.56 mg/L.

In a 14 day subchronic study in fish, the NOEC was reported to be 50 mg/l (length) and the LC50 greater than 100 mg/L. In a 21 day Daphnia reproduction toxicity study, the NOEC was greater than 100 mg/L, the highest concentration tested.

The reported toxicity data for MEKO in micro-organisms was greater than 100 mg/L.

Conclusion on classification

The substance is not classified for environmental hazards on Annex I of EU Directive 67/548/EEC and Annex VI of EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

Based on the available data, self-classification of MEKO for aquatic toxicity is also not warranted. The lowest 72-h EC50 of 11.8 mg/L was obtained in a short-term study with algae. This value is well above the classification limit for Acute Aquatic Toxicity Category 1 according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 or R50 according to EU Directive 67/548/EEC. As the substance has a BCF value ranging from 0.5 to 5.8, a log Kow of 0.63 and the NOECs for fish and Daphnia were above 1 mg/L, classification for chronic aquatic toxicity is also not warranted.