Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.1 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
10 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.5 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:
0.412 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

PNEC sediment and PNEC soil were calculated by the equilibrium partitioning method since no measured data were available.

Conclusion on classification

Aquatic compartment

Official classification

In accordance with Regulation (EC) No 1272/2008, Annex VI Table 3.1 or Table 3.2, trimethylenediamine is officially not classified.

Self-classification

Aquatic compartment

Following GHS, the substance is not to be classified as acutely hazardous to the aquatic environment. Based on the available acute and chronic data, the substance is not to be classified as chronically hazardous to the aquatic environment.

Rationale:

The substance is not to be classified as acutely hazardous to the aquatic environment, since the lowest acute effect value is > 1 mg/L.

Chronic data are only available for algae and aquatic invertebrates, therefore classification is based on the available chronic and acute toxicity data.

- Chronic toxicity data:

Considering the long-term toxicity data to aquatic invertebrates the 21-d NOEC of trimethylenediamine (CAS 109-76-2) was determined to be ≥ 10 mg/L. Considering the toxicity to aquatic algae the 72-h NOEC was determined to be ≥ 500 mg/L.

The lowest chronic effect value is ≥ 10 mg/L, indicating that the substance does not represent a long-term hazard according to the categories outlined in Table 4.1.0(b) (ii) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008) for rapidly degradable substances.

- Acute toxicity data:

Acute toxicity to aquatic organisms (LC/EC50) is between 10 and 100 mg/L in freshwater (48-h EC50 Daphnia: 27 mg/L).

However, the substance is rapidly biodegradable (freshwater) and the log Kow is <4.