Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.009 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:
0.006 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Experimental data investigating the ecotoxicity of TMEDA are available from a short-term fish toxicity study, a short-term Daphnia toxicity study and an algal growth inhibition study. Long-term ecotoxicity data are not available for fish or aquatic invertebrates. The algal growth inhibition study showed the most conservative toxicity data from these studies, having resulted in a 72-h ErC50 value of 20.5 mg/L and a 72-h NOEC of 0.954 mg/L.

A ready biodegradability study according to the OECD guideline 301B is available, the results of which concluded that TMEDA is not readily biodegradable. 

Based on the above information, self-classification would assume that TMEDA is not classified for acute aquatic toxicity under the CLP regulation (Regulation (EC) No 1272/2008) but is classified as acute aquatic toxicity, Category 2 (H401) under the Globally Harmonised System (GHS), and is also classified as chronic aquatic toxicity, Category 2 (H411) under both the CLP regulation and GHS. However, a harmonised classification (Annex VI) is available for TMEDA which concludes that the substance is not classified for either acute or chronic aquatic toxicity.