Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
1.2 ng/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
12 ng/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.12 ng/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
1.2 ng/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
5.16 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:
10.3 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Additional information

Conclusion on classification

Experimental data investigating the ecotoxicity of Epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2 -dicarboxylic anhydride and propylidenetrimethanol are available from a short-term fish toxicity study (Tobor-Kaplon, 2018), a short-term Daphnia toxicity study (Sileno, 2018a) and an algal growth inhibition study (Sileno, 2018b). Long-term ecotoxicity data are not available for fish or aquatic invertebrates. In all three available studies, no toxicity was observed in the limit tests (i.e. no toxic effects occurred at the limit of solubility of the substance), with the lowest L(E)C50 value shown to be >1.2 µg/L in the algal growth inhibition study. 

A ready biodegradability study according to the OECD guideline 301B is available, the results of which concluded that Epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2 -dicarboxylic anhydride and propylidenetrimethanol is not readily biodegradable, having shown no biologically significant biodegradation (Timmer, 2017). Although the partition coefficient (log Kow) of the substance was concluded to be >7.99 (Reingruber, 2018), the high molecular weight of the substance of 1281.67 would suggest that the substance is too large to pass biological membranes and is therefore not expected to be potentially bioaccumulative.

The available ecotoxicology data are not considered sufficient to assign an environmental hazard classification (given the constraints associated with the water solubility of the substance), however the substance was shown to be not readily biodegradable. As such, the safety net classification of chronic aquatic toxicity, category 4 (H413) has been assigned.