Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.002 mg/L
Assessment factor:
10 000
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:
0.16 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.016 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:
0.09 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Justification for Read Across

Attached at section 13 is a category justification that explains the rationale for using data on a mixture of Dimethyl Esters (DBE), and Dimethyl Glutarate, to supplement the available data on Dimethyl Adipate.

Conclusion on classification

The lowest acute aquatic toxicity result was obtained on fish and gives a 96hLC50 value between 18 and 24 ppm (v/v). Considering that the relative density of the substance is around 1, the 96hLC50 value is expected to be between 18 and 24 mg/L. Therefore, the substance should be considered as harmful to the aquatic organisms tested.

Additionaly, the substance is readily biodegradable and has a low potential for bioaccumulation (i.e. logKow = 0.6 - 1.4). Therefore, the substance is not classified as dangerous for the environment according to European Directive 67/548/EEC and to Regulation (EC) No 1272/2008.