Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
1.25 g/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.758 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:
1.27 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The calculated PNEC aquatic for the amine heads category is 0.42 mg/L based on the Daphnia magna reproduction study. Invertebrates are by far the most sensitive trophic level. The amine heads category consistently was shown to be readily biodegradable with total nitrification and fulfilment of the 10-day window-requirement. Due to the short carbon chain lengths of the member-compounds the category does not show surface active properties and the octanol-water partition coefficient is very low. Distribution to sludge, sediment or soil therefore is highly unlikely.

PNECs for soil and sediment for the category member MPMD were calculated using the Equilibrium Partitioning Method. Details of the procedure are given in the "Justification" field for each PNEC.

Conclusion on classification

Classification according directive 2008/1272/EEC (CLP)

Classification according directive 2008/1272/EEC (CLP) is performed independently for acute and chronic hazards.

Actute hazard category:

The lowest acute aquatic toxicity of three trophic levels was determined for Daphnia magna with an acute EC50 (48 h) of 31.5 mg/L.

Thus no acute classification results from the available acute aquatic ecotoxicity data.

Chronic hazard category:

Using available acute data, decisive for a possible chronic classification is failure or fulfillment of (1) rapid degradability and / or (2) presence or absence of a bioaccumulation potential.

As substitute for an experimentally determined BCF in fish log KOW is taken as an indicator of bioaccumulation potential. As log KOW of the amine heads category is clearly below the cut-off value according to CLP of 4.0 (0.09-0.4), the category is regarded as non-bioaccumulative.

Rapid biodegradability according to CLP is given for substances which were assessed as “readily biodegradable” in screening studies (OECD 301) with a minimum of 60% O2 -depletion of theoretical maximum within 28 days and at the same time fulfillment of the 10-day-window. This is met by all three substances of the category. The compounds of the amine heads category are thus rapidly biodegradable.

Under these circumstances, no chronic classification results for the amine heads category from the available acute data on ecotoxicity.

Also using available chronic data (algae, invertebrates) with the NOEC (21 days, reproduction) for Daphnia magna as representative of the most sensitive trophic level (invertebrates) of 4.16 mg/L, the classification scheme for adequate chronic data applicable for rapidly degradable substances results in no chronic classification.

Classification according directive 67/548/EC (DSD)

The lowest acute aquatic toxicity of three trophic levels was determined for Daphnia magna with an acute EC50 (48 h) of 31.5 mg/L. The amine heads category is readily biodegradable and has no potential for bioaccumulation (log Kow << 3.0).

Thus, no classification according to directive 67/548/EC (DSD) is resulting.