Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.25 mg/L
Assessment factor:
100
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:
25.4 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
2.54 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:
3.6 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

For the three trophic levels in the aquatic compartment acute and chronic ecotoxicity data are available. The basis for the derivation of the PNEC freshwater is the EC10 reproduction (21d) of 25 mg/L for daphnia which is the most sensitive species. Due to the low sorption of the registration substance to sediment and soil the Equilibrium Partitioning Method was used to derive the PNEC sediment and PNEC soil. The PNEC marine water and PNEC marine sediment were derived from the corresponding PNEC freshwater respectively PNEC freshwater sediment applying an assessment factor of 10.

Conclusion on classification

For the three trophic levels in the aquatic compartment acute and chronic ecotoxicity data for TPSA are available. All acute values L(E)C50 are >100 mg/Land the lowest chronic value is the EC10 reproduction (21d) daphnia of 25 mg/L.

The registration substance is not readily biodegradable and not bioaccumulative (log Kow = 2.8).

Short-term effects

Proposed classification according DSD 67/548/EEC:

no classification required as lowest acute EC50 is > 1 mg/L

Proposed classification according CLP (2nd) ATP 2011/286/EC:

no classification required as lowest acute EC50 is > 1 mg/L

Long-term (chronic) effects

Proposed classification according DSD 67/548/EEC:

no classification required as all acute L(E)C50 are > 100 mg/L

Proposed classification according CLP (2nd) ATP 2011/286/EC:

no classification required as lowest chronic value EC10 reproduction (21d) daphnia is > 1 mg/L.

OVERALL CONCLUSION ON ENVIRONMENTAL CLASSIFICATION

Based on the available acute and chronic freshwater ecotoxicity data and considering the fact that TPSA is not readily biodegradable and not bioaccumulative, it can be concluded that no environmental classification is required, neither under DSD 67/548/EEC nor under CLP wnd ATP 2011/286/EC.