Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.011 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

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

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.079 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Additional information

Methyl propyl ketone (MPK) demonstrates low acue toxicity to freshwater fish, invertebrates (daphnia) and plants (algae). PNECs for freshwater and marine organisms were calculated based upon the most sensitive acute result with conservative assessment factors applied. PNECs for soil and sediment were derived using the equilibrium partitioning method. A PNEC for secondary poisoning was not calculated as the substance is readily biodegradable and has a very low log Kow which provides strong evidence for a lack of bioaccumulation or secondary poisoning potential.

Conclusion on classification

Adequate acute data for aquatic invertebrates, fish, and aquatic algae are available along with ready biodegradation and log Kow data for assessing classification according to CLP and GHS criteria. In addition the chronic NOEC from the algal toxicity study allows further assessment of classification according to GHS and the March 2011 revision of the CLP for substances with adequate chronic data available. Methyl propyl ketone (MPK) is rapidly degradable based upon a demonstration of ready biodegradability. MPK also has a log Kow of < 4. Based upon the most sensitive acute endpoint of an algal EC50 for growth rate of 110 mg/L, and the most sensitive chronic endpoint from the algal study NOEC of 74 mg/L, in conjunction with the persistence and bioaccumulation data, MPK does not meet the criteria for classification for environmental effects under the European CLP or GHS criteria.