9-Octadecenoic acid (Z)-, reaction products with diethylenetriamine, di-Me sulfate-quaternized

PBT assessment

PBT assessment: overall result

Reference

Name:

9-Octadecenoic acid (Z)-, reaction products with diethylenetriamine, di-Me sulfate-quaternized

Type of composition:

legal entity composition of the substance

State / form:

other: solid paste

Reference substance:

9-Octadecenoic acid (Z)-, reaction products with diethylenetriamine, di-Me sulfate-quaternized

Reference substance:

9-Octadecenoic acid (Z)-, reaction products with diethylenetriamine, di-Me sulfate-quaternized

PBT status:

further information relevant for the PBT assessment is necessary

Justification:

Persistence

A weight of evidence (WoE) was carried out on six available studies assessing the biodegradation potential of the test substance and two read-across substances. Based on the WoE approach, the test substance is classified as not readily biodegradable, however the evidence suggests that some biodegradation of particular constituents or under particular conditions is likely in these UVCB substances.

Two studies are available investigating the hydrolysis of two different read-across substances. Based on a WoE approach from the data on the read-across substances it is evident that some of the constituents of the test substance are likely to undergo hydrolysis, however this may not be an important process for other constituents that are largely insoluble, at least at the concentrations required in hydrolysis tests.

Three studies on read-across substances considered the adsorption potential. Two studies estimated the adsorption coefficient used the HPLC method and determined adsorption coefficients of >427,000 (Koc) and >5.63 (Log Koc) at 25˚C and 35˚C. One further study measured adsorption and desorption based on the batch equilibrium method and determined that adsorption was nearly 100% in all soils with Koc values of 135,000 and a very limited potential for desorption.  Based on these results the test substance is expected to be highly adsorptive and immobile in soils and sediment.

Bioaccumulation

A bioaccumulation test is not available at this low usage tonnage of test material. The partition coefficient could not be performed using reliable methods (flask method or the HPLC method) due to the test material being determined as surface-active. Therefore, an estimation of the partition coefficient of the test item individual constituents was performed using the specialized software KOWWIN, version 1.68, September 2010, © 2000, US Environmental Protection Agency. This provided an estimated logPow of the long chain amide species as 12.4 and an estimated logPow of the methyl sulphate component of -2.98.

It is stated in ECHA Guidance R.7c, that "based on current knowledge, for PBT assessments, a calculated log Kow of 10 or above is taken as an indicator of reduced bioconcentration". Therefore, both the very low Log Pow and the very high Log Pow’s are not indicative of a high potential for bioaccumulation, although limited information is available to validate this at present.

Toxicity

Of the fish, algae and invertebrate acute toxicity studies, the algal endpoints represent the lowest and most conservative EC50 and NOEC values. The EL50 (growth rate) is 0.29 mg/l and the NOEC 0.10 mg/l. The EL50 and NOEC values are above the screening criteria used to classify T properties based on the environmental profile (not T). There is no evidence to suggest the substance is CMR or there are any other acute toxicity concerns.