Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
10 µg/L
Assessment factor:
50
PNEC freshwater (intermittent releases):
10 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
1 µg/L
Assessment factor:
500

STP

Hazard assessment conclusion:
no data: aquatic toxicity unlikely

Sediment (freshwater)

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Sediment (marine water)

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no or insufficient data available at present

Additional information

Volumes below < 10 ton no risk assessment is required.

A long-term daphnia test has been performed with Oleyl dipropylene triamine (C18dipropylene triamine; CAS 28872-01-7). The test is considered valid as all validity criteria have been fulfilled. Based on the test setup (GLP, guideline study) and the extensive effort which has been paid to ascertain a realistic exposure of the test organisms and to quantify the extent of this exposure the results are considered to be reliable. Finally, the test result is considered adequate for the evaluation of the environmental risks in the EU applying the bulk approach considering the realistic worst case (low) concentrations of suspended matter and dissolved organic carbon in the river water used. In order to reduce the influence of these secondary effects, modifications such as river water tests (or tests in the presence of humic acids) can be introduced as stabilizers of the test substances, which limits the sorption to organisms and glassware and at the same time creates more realistic conditions. These studies should therefore be considered as higher tier studies.

Given that that the molecular weight of the amine acetates is significantly higher than the molecular weight of the amines (Oleyl dipropylene triamine +47%, Tetramine +55%) a direct cross-reading on the basis on levels in mg/kg bw or mg/L, would represent a (large) overestimation of the toxicity for the acetates, and thus serves as a worst case approach providing an additional safety margin.

Conclusion on classification

For classification purposes, when river water tests are used, a mitigation factor of 10 is applied as agreed among the European Oleochemicals and Allied Products Group (APAG) ecotoxicologists. This means that the EC50/EC10 are divided by 10.