Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.8 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
8 µg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
3.59 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:
7.17 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

Official classification regarding environmental hazards

Aquatic compartment

There are no data in Regulation (EC) 1272/2008 Annex VI Table 3.1 and 3.2 for the substance available yet.

 

Self-classification according to REGULATION (EC) No. 1272/2008 (CLP)

Following EU-GHS, the substance is not to be classified as acutely hazardous to the aquatic environment. Based on the available chronic and acute 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; therefore classification is based on the available chronic and acute toxicity data.

 

- Chronic toxicity data:

Considering the toxicity to aquatic algae a 72-h EC10 of 4.64 mg/L (geometric mean measured) was determined for tributylamine. The lowest chronic effect value is > 1 mg/L, indicating that the substance does not present 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.Therefore, the substance has not to be classified as chronically hazardous to the aquatic environment.

 

- Acute toxicity data:

Acute toxicity to aquatic organisms (LC/EC50) is between 1 and 10 mg/L in freshwater (lowest acute effect value: 48 -h EC50 for daphnids = 8 mg/L).

The substance is rapidly biodegradable and the log Kow is < 4. Therefore, also based on acute data, no chronic classification is applicable for the submission substance.

 

In conclusion, the substance is not to be classified as acutely or chronically hazardous to the aquatic environment.

Atmospheric compartment

The test substance is not in Annex I of Regulation (EC) 2037/2000 on substances that deplete the ozone layer.

The test substance does not belong to the greenhouse gases listed in P Forster, PV Ramaswamy et al. Changes in Atmospheric Constituents and in Radiative Forcing. In: Climate Change 2007: The Physical Basis. Contribution of Working Group I to the Fourth Assessment Report of the Intergovernmental Panel on Climate Change.

Self-classification according to UN-GHS ST/SG/AC.10/30 /Rev.7 (2017)

Because of E(L)C50-Values between 1 and 10 mg/L, the following acute toxicity classification applies:

o       Aquatic Acute 2

o       H401: Toxic to aquatic life.

For chronic aquatic toxicity, no classification is applicable (see EU-GHS above for details).