Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.006 mg/L
Assessment factor:
100
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:
3.26 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.33 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:
0.038 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

PNECs

The PNECs for the different compartment can be calculated either by applying an assessment factor (PNECfreshwater, marine water, intermittent release and STP) or using the equilibrium assumption method (PNECsediment freshwater, marine water and soil). The PNECoral and PNECair are not considered as relevant. The utilized procedures are described in detail in the ECHA Guidance of May 2008, Chapter R.10 ("Guidance on information requirements and chemical safety assessment").

Classification and Labelling

The available chronic toxicity data to fish, together with data available concerning biodegradation, lead to the classification and labelling according to the second Adaption to Technical Progress (ATP) (Commission Regulation (EU) No. 286/2011) of Regulation (EC) No. 1272/2008.

Adequate acute as well as long-term toxicity data concerning aquatic organisms are available. The 50-day early life stage (egg-fry) test with Salmo gairdneri (new name: Oncorhynchus mykiss) as test organisms, resulted in a mortality-based NOEC of 0.6 mg/L (Calamari, 1979).

The test substance was found to be readily biodegradable (experimentally determined according to OECD 301C and other non-guideline test methods, confirmed by a prediction with QSAR).

Based on these results, Dimethylamine has to be classified as "Aquatic Chronic 3" with Hazard statement 412 (H412; Harmful to aquatic life with long lasting effects) and Precautionary statemtents P273 (Avoid release to the environment) and P501 (Dispose of contents/container in accordance with local/regional/national/international regulations). No pictogram and no signal word are used for labelling purposes.

Conclusion on classification

Regarding all available data of the acute and/or chronic toxicity tests on aquatic organisms and taking into account the provisions laid down in Council Directive 67/548/EEC and CLP (GHS), Dimethylamine is classified as "Aquatic Chronic 3" with Hazard statement 412 (H412; Harmful to aquatic life with long lasting effects) and Precautionary statements P273 (Avoid release to the environment) and P501 (Dispose contents/container in accordance with local/regional/national/international regulations). No specific labelling is applied.