Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no data: aquatic toxicity unlikely

STP

Hazard assessment conclusion:
no data: aquatic toxicity unlikely

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.04 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:
0.32 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
222.22 mg/kg food
Assessment factor:
90

Additional information

Conclusion on classification

The substance tris(2-ethylhexyl) 2-(acetyloxy)propane-1,2,3-tricarboxylate is an extremely water - insoluble substance (0.00000078 mg/L at 20°C, est. by US EPA program WSKOWWIN v.142) for which no acute toxicity to daphnids and algae - the two most sensitive species - was recorded at levels up to the Water Accommodated Fraction of nominal 100 mg test item/L, the concentration representing the limit of solubility.

Tris(2-ethylhexyl) 2-(acetyloxy)propane-1,2,3-tricarboxylate is not rapidly degradable and has an experimentally determined log Pow ≥ 4, indicating a potential to bioaccumulate. Normally, according to the Classification, Labelling and Packaging Regulation EC (No) 1272/2008 the substance needs to be classified as Aquatic Chronic 4 (H413) unless other scientific evidence exists; such evidence includes chronic toxicity NOECs > 1 mg/L (or at the solubility level).

A chronic toxicity test on the structural analogue tributyl 2-acetoxypropane-1,2,3-tricarboxylate (CAS 77-90-7) is available for Daphnia Magna: the NOEC from this test amounts to >= 1.11 mg/L, representing a conservative estimate of aquatic toxicity.

As conclusion, taking all these facts and the low bioavailability (low bioconcentration potential, very high adsorption potential to soil and rapid degradation in air) of the substance tris(2-ethylhexyl) 2-(acetyloxy)propane-1,2,3-tricarboxylate into account, it does not need to be classified and labelled according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council since no acute/chronic toxicity is expected up to its limit of solubility in water.