Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
20 mg/L
Assessment factor:
1
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.09 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:
0.117 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Additional information

Aquatic toxicity data are available for fish, daphnia, and aquatic algae. No effects were observed in any of the aquatic toxicity studies at mean measured concentrations 109 mg/L and that value is being utilized to determine the PNECs for freshwater, marine water, and intermittent releases using the appropriate assessment factors. The PNEC STP is derived from the concentration utilized in a wastewater treatement simulation study showing 100% removal on a daily basis. The equilibrium partitioning method has been utilized to calculate the PNECs for soil and sediment. The assessment of secondary poisoning is most relevant for certain lipophilic organic materials and some metal compounds. TMPD has a low potential for bioaccumulation, based on a log Kow value of <3.0. Thus, an assessment of secondary poisoning and the calculation of a PNECoral value for TMPD were not performed.

Conclusion on classification

Aquatic toxicity data is available for fish, daphnia, and aquatic algae. No effects were observed in any of the aquatic toxicity studies at mean measured concentrations 109 mg/L. TMPD is a readily biodegradable substance. TMPD has a low potential for bioacumulation based upon a log Pow < 3.0. The lowest acute toxicity value with regards to classification is the 48 -hour EC50 of 109 mg/L from the daphnia study. Chronic data is available from the algal study as an NOEC of 110 mg/L. Based upon the lack of aquatic toxicity stated above, and the fact that the substance is readily biodegradable, the substance is not classified for environmental effects under the EU DSD or CLP regulations or the UN GHS classification system.