Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.01 mg/L
Assessment factor:
10 000
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:
1.07 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.107 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:
0.156 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

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 106 mg/L and that value is being utilized to determine the PNECs for freshwater, marine water, and intermitent releases using the approriate assessment factors. The PNEC STP is calculated from the NOEC determined in an activated sludge respiration inhibition study using the appropriate assessment factor. 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. TMCD has a low potential for bioaccumulation, based on a logKow value of <3.0. Thus, an assessment of secondary poisoning and the calculation of a PNECoral value for TMCD 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 106 mg/L. TMCD is not considered a readily biodegradable substance under the conditions of the single test that has been performed. TMCD has a low potential for bioacumulation basd upon a log Pow < 3.0. The lowest acute toxicity value with regards to classification is the 48 -hour EC50 of 106 mg/L from the daphnia study. Chronic data is available from the algal study as an NOEC of 108 mg/L. Based upon the lack of aquatic toxicity stated above, the substance is not classified for environmental effects under the EU DSD or CLP regulations or the UN GHS classification system.