Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.095 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.3 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.009 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

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:
18 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
1.8 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:
99 mg/kg soil dw
Assessment factor:
10
Extrapolation method:
assessment factor

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

WS400128 is a UVCB substance with a water solubility below 0.1 mg/l. The substance forms dispersions in water. All aquatic toxicity studies were performed with Water Accomodated Fractions (WAF) that finally were dispersions of the substance. All NOEC values determined in the aquatic toxicity tests were well above the actual water solubility of WS400128. WS400128 is not classified as hazardous to the environment.

In the biodegradation test ready biodegradability of WS400128 could not be demonstrated, but part of the substance was degraded. The UVCB substance WS400128 is a mixture of fatty acid esters with molecular weights ranging from approx. 360 D to 940 D. The substance forms dispersions in water which reduces the bioavailability of the molecules. It is rather likely that this reduced bioavailability of the fatty acid esters prevented their (ready) biodegradation in the standard test.

Based on the chemical composition of WS400128, i.e. fatty acid esters with triethanolamine, it is to be expected that the esters are hydrolysed in biological systems. Toxicity and metabolism of the hydrolysis products are already well characterized showing very low toxicological potentials and no bioaccumulation potential.

Conclusion on classification

The results of all ecotoxicological tests do not warrant any classification with regard to environmental hazards according to Regulation (EC) 1272/2008.