Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.126 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.521 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.013 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.12 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:
0.167 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

Classification related key information

Biodegradation in water: No biodegradation observed (OECD 302 B)

Log Kow: 0.73 at pH 4, 0.01 at pH 7, -1.55 at pH 9 (ACD/LogD Suite Program, v12)

 

Acute toxicity:

- to Fish: LC50 (96 h) > 137.2 mg/L for Oryzias latipes (OECD 203), recalculated value

- to aquatic invertebrates: EC50 (48 h) = 52.1 mg/L for Daphnia magna (OECD 202), recalculated value

- to Algae: ECr50 (72 h) > 130.2 mg/L, for Pseudokirchneriella subcapitata (OECD 201), recalculated value

 

Chronic toxicity:

- to Fish: not available

- to aquatic invertebrates: NOEC (21 d) = 6.31 mg/L for Daphnia magna (OECD 211), recalculated value

- to Algae: NOEC (72 h) = 7.8 mg/L for Desmodesmus subspicatus (OECD 201), recalculated value

 

Classification justification according to CLP

Based on the data above, TMT is considered to be not rapidly biodegradable. The acute aquatic toxicity L(E)C50 values are > 1 mg/L for fish, aquatic invertebrates and algae. Valid chronic toxicity data are available for invertebrates and algae with the lowest NOEC of 6.31 mg/L for Daphnia magna. Therefore, TMT does not need to be classified and labelled as environmental hazard according to the Regulation (EC) No. 1272/2008 (CLP) and the Regulation (EU) No. 286/2011 (2ndATP).

 

Classification justification according to DSD

Based on the data above, TMT is considered to have low potential for accumulation and is not rapidly degradable. Acute aquatic toxicity data are available for fish, aquatic invertebrates and algae, the lowest EC50 value is > 10 and < 100 mg/L for Daphnia magna. Valid chronic toxicity data are available for invertebrates and algae - the lowest NOEC is > 1 mg/L. Therefore, TMT does not need to be classified and labelled as environmental hazard according to the Directive 67/548/EEC.