Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.006 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.004 mg/L

Marine water

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

STP

Hazard assessment conclusion:
no emission to STP expected

Sediment (freshwater)

Hazard assessment conclusion:
no exposure of sediment expected

Sediment (marine water)

Hazard assessment conclusion:
no exposure of sediment expected

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

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

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

This substance is not dangerous, and does not need an exposure assessment under REACH. PNECs were derived for use in exposure-based waiving aquatic chronic and soil ecotox studies listed in Annex IX. Using available ecotoxicological data, the PNECs were calculated to be 0.0059 mg/L for Freshwater and 0.00059 mg/L for Marine Water.  For the calculation of the Freshwater and Marine water PNECs; a 21-day NOEC value of 0.295 mg/L was obtained from PMM media solubility and toxicity results from a read-across study with Daphnia magna from category member PTBA. Because three acute studies (fish, Daphnia and algae) and two chronic studies (algae and Daphnia) were available, and the chronic studies were conducted on the organism with the most sensitve acute toxicity (Daphnia), an AF of 50 was applied to the Daphnia chronic NOEC.  An assessment factor of 500 was applied to the freshwater NOEC to derive the PNECmarine. For the freshwater (intermittent) PNEC, the lowest of three acute values, the 48-hr EC50 of > 0.408 mg/L for Daphnia magna, was used with an AF of 100 to obtain a value of 0.00408 mg/L  For Grassland and Agricultural soil, no testing results were available.  The EPM method applied to the Freshwater PNEC was used to derive soil PNECs.  Using the calculated Koc of 3981 L/kg, the PNEC for Grassland and Agricultural soil was determined to be 0.2453 mg/kg based on wet weight and 0.2772 mg/kg based on dry weight. 

Conclusion on classification

Hazardous to the aquatic environment - acute/short-term: conclusive but not sufficient to classify. No acute toxicity at the limit of water solubility.

Hazardous to the aquatic environment - long-term: conclusive but not sufficient to classify. Not chronically toxic at limit of water solubility. Not persistent in aquatic environment.

M-factor chronic: not applicable.

Hazardous to the ozone layer: conclusive but not sufficient to classify. PMM is not listed in the Montreal Protocol on Substances that Deplete the Ozone Layer. It does not contain reactive halogens (chlorine or bromine) that could play a role in ozone depletion. PMM is not hazardous to the ozone layer.

DSD endpoints environment: not classified. No acute toxicity at the limit of water solubility. Not persistent in the aquatic environment.