Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
9.05 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.905 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.003 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:
0.001 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Although this substance is not inherently biodegradable it is extremely soluble (> 1000 mg/l), has a low Log Pow (-2.45) and the studies at this level indicate that it will therefore not be classified for environmental toxicity.

The three acute ecotoxicity studies were conducted at varying pH’s. An analysis of the effect of hydrolysis on the ecotoxicity test concentrations was conducted and is documented in detail in Appendix 1. At pH 7 the test concentrations varied between 0.33% and 58.53% of nominal at the end of the exposure period and at pH 9 test concentrations varied between 10.65% and 97.97% of nominal at the end of the exposure period. While the hydrolysis study was not conducted at the pH’s that the ecotoxicity studies were conducted at so the results from this analysis cannot be viewed as definitive, these results strongly suggest that it is likely that algae, fish and daphnia magna were exposed to Epofloc L-1R’s breakdown product, TEPA. It is likely that some, if not all, toxicity observed in the studies was derived from the presence of TEPA. 

No reliable ecotoxicity data was available for TEPA, therefore, the ecotoxicity endpoints for Epofloc L-1R were used to represent TEPA toxicity. As the ecotoxicity endpoints are expressed as Epofloc L-1R, the assessment was conducted for ‘Epofloc L-1R equivalents’ rather than TEPA to allow comparison with the ecotoxicity data. The molecular weight for Epofloc L-1R and the physical-chemical and environmental fate parameters for TEPA were used to model fate of ‘Epofloc L-1R equivalents’. The physical-chemical and environmental fate parameters for TEPA were taken from the OECD SID for Tetraethylene pentamine (UNEP, 2001).

Conclusion on classification

The studies indicate at this level (Annex VIII) that this substance is not classified for environmental toxicity.