1-Propanamine, 3-(C9-11-isoalkyloxy) derivs., C10-rich

Endpoint summary

Additional information

Etheramine and etheramine acetate are moderately soluble in water and etheramines have a strong tendency to adsorb to negatively charged surfaces such as suspended matter and dissolved organic matter such as humic acids. The etheramine and etheramine acetate are difficult substances to test in environmental toxicology. Standard guideline studies are inappropriate to test substances with such properties and the current REACH Guidance Documents do not provide sufficient guidance concerning bioavailability and ecotoxicity testing for cationic surface-active substances like these etheramines as these were written with neutral hydrophobic chemicals in mind, failing to take into account the lack of bioavailability that occurs in the environment with these substances.

The ecotoxicity tests with etheramine and etheramine acetate were therefore performed in river water to allow a PECaquatic, bulk / PNECaquatic, bulk approach. The difficulties encountered with the standardized ecotoxicity tests for these surfactants are avoided by the use of river water tests. For ecotoxicity tests performed with river water, adsorption to suspended matter and DOC is acceptable and only adsorption to glassware should be accounted for. For a valid bulk approach test, the concentration-effect relationship should be based on the sum of adsorbed and dissolved substance in the volume of the medium tested. All effect values are therefore based on nominal concentrations. One of the advantages of the bulk approach tests with these difficult substances is that in the presence of suspended matter, humic acids and/or algae, the residual sorption to glassware will be negligible. Analytical measurements confirmed that the sorption to glassware was negligible (1%) in the tests with river water The results of these bulk approach tests are therefore much easier to interpret. Moreover, the PNECbulk provides a more environmentally realistic estimation than the PNEC based on dissolved concentrations in reconstituted lab water. The PNECbulk should be compared to the PECbulk which reflects the total aquatic concentration (also including substance adsorbed to suspended matter and DOC).

The aquatic toxicity data have been pooled for 3-(Isodecyloxy)propylamine and 3-(Isodecyloxy)propylamine acetate based on the structural similarity of both substances. 3-(Isodecyloxy)propylamine and its acetate have the same chemical structure with the latter being neutralized with acetate. The presence of acetate has no effect on the ecotoxicity of the substance.

The key aquatic toxicity data are presented in the table.

It should be noted that the 21d-EC50 for daphnia in river water has been included as a worst case for the short term EC50 daphnia. The results of the range finding tests confirm that this 21d value can be considered a worst case for the acute toxicity to daphnia.

Long term fish testing has been waived as fish is clearly less sensitive to the substance compared to daphnia and algae. Acute toxicity results are available for three taxonomic groups (fish, invertebrates and algae). Long term toxicity results are available for aquatic invertebrates and algae. As fish is clearly less sensitive than daphnia and algae towards the substance, no further long term testing with fish is proposed to avoid further vertebrate testing. Moreover the low bioaccumulation potential does not trigger the need for long term fish testing either. Therefore long term fish testing has been waived.

All effect concentrations are based on the active substance content.

Overview toxicity data Etheramine acetate and etheramine

	Etheramine CAS no 30113-45-2	Etheramine acetate CAS no 28701-67-9
Danio rerio OECD 203	Read across from etheramine acetate	96h-LC50 = 2.14 mg/L *
Daphnia range finding OECD202	48h-EC0immobilisation = 1 mg/L 48h-EC100immobilisation = 10 mg/L	48h-EC0immobilisation = 1 mg/L 48h-EC100immobilisation = 10 mg/L
Daphnia OECD 211	21d-EC50parental = 1.91 mg/L river water 21d-EC10repro = 1.22 mg/L river water	21d-EC50parental = 1.05 mg/L river water * 21d-EC10repro = 0.738 mg/L river water *
Pseudokircherniella subcapitata OECD 201	72h-ErC50 = 0.0827 mg/L river water * 72h-ErC10 = 0.0421 mg/L river water *	72h-ErC50 = 0.15 mg/L river water 72h-ErC10 = 0.085 mg/L river water
Microorganisms OECD 209	3h-EC50 = 23.6 mg/L * 3h-EC10 = 13 mg/L *	3h-EC50 = 35.3 mg/L 3h-NOEC = 6.25 mg/L

  * Figures in bold are key data.