Amines, N-(C16-18 and C18-unsatd. alkyl)trimethylenedi-, dioleates

Endpoint summary

Additional information

Amines, N-C16-C18-alkyl-(evennumbered, C18 unsaturated) propane-1,3-diaminium di[(9Z)-octadec-9-enoate] is poorly soluble in water and is expected to have a low bioaccumulation potential. According to EPISuite the BCF is predicted as 70.8 L/kg wetweight. In the environment the substance will end up in sludge, and possibly in soil and sediments. However, the substance is biodegradable so the fraction going to sludge, soil and sediment is expected to be low.

Aquatic toxicity data for Amines, N-C16-C18-alkyl-(evennumbered, C18 unsaturated) propane-1,3-diaminium di[(9Z)-octadec-9-enoate] are available for algae and microorganisms. Data for fish (acute) and Daphnia (acute and chronic) are read-across from N-[(9Z)-octadec-9-en-1-yl]propane-1,3-diaminium di[(9Z)-octadec-9-enoate].

Both short- and long-term aquatic ecotoxicity tests with both Amines, N-C16-C18-alkyl-(evennumbered, C18 unsaturated) propane-1,3-diaminium di[(9Z)-octadec-9-enoate] and N-[(9Z)-octadec-9-en-1-yl]propane-1,3-diaminium di[(9Z)-octadec-9 -enoate] were performed in river water to allow a PECaquatic,bulk/PNECaquatic, bulk approachand are considered to be more environmentally realistic than the standard method. This approach is based on PEC estimations representing ‘total aquatic concentrations’. To characterize the risk to the aquatic compartment the PECaquatic,bulk is compared with the PNECaquatic,bulk derived from river water ecotoxicity studies (ECETOC, 2001). The difficulties encountered with the standardised 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. 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.The results of these bulk approach tests are therefore much easier to interpret. 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. All effect values given are therefore based on the nominal test item concentrations.

 

It should be noted that the 21d-EC50 for daphnia, river water has been included as a worst case for the short term EC50-daphnia, river water. The effect concentrations are based on the active ingredient content.

An overview of the most relevant results is presented in the table. 

	CAS number	Result	Reference
Danio rerio OECD 203 KEY Study (Rel. 1)	34140-91-5	96h-LC50 = 1.34 mg/L, natural river water	AkzoNobel, 2012
Daphnia magna OECD 211* KEY Study	34140-91-5	48h-EC50 (*= 21d-EC50 from chronic test as worst case approach) = 1.40 mg/L, natural river water	Noack, 2012
Pseudokircherniella subcapitata OECD 201 KEY Study	13078630-78-0	72h-ErC50 = 0.502 mg/L, natural river water 72h-ErC10 = 0.319 mg/L, natural river water	Scheerbaum, 2012
Daphnia OECD 211 KEY Study	34140-91-5	No long-term effects were observed during the chronic daphnia test. For adult mortality the following effects were observed: 21d-EC10 = 1.35 mg/L, natural river water 21d-EC50 = 1.4 mg/L, natural river water	Noack, 2012
Microorganisms OECD 209 Key Study	13078630-78-0	3h-NOEC = 986 mg/L	Klee, 2012

 

According to Annex IX, 9.1.6 to the REACH Regulation long-term toxicity testing with fish shall be proposed only if the CSA indicates the need to investigate further the effects on aquatic organisms. However, as the CSA does not indicate the need for further testing of vertebrates, long-term toxicity testing with fish is waived.