Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Additional information

Justification for grouping of substances and read-across

There are no data available on the biodegradability of (Z) -N-Octadecyldocos-13-enamide (CAS No. 10094-45-8). In order to fulfil the standard information requirements set out in Annex VII, Section 9.2.1.1., in accordance with Annex XI, Section 1.5 of Regulation (EC) No 1907/2006, read-across from structurally similar substances is conducted.

In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human and environmental toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).

Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006, whereby physicochemical, toxicological and ecotoxicological properties may be predicted from data for reference substance(s) by interpolation to other substances on the basis of structural similarity, N-octadecylstearamide (stearyl stearamide, CAS 13276-08-9) is selected as read-across substance for assessment of biodegradation.

The read-across is based on structural similarity as a result of common origin and production process line. A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

Table. Environmental fate properties of target and source substances

Name/CAS #

(Z)-N-Octadecyldocos-13-enamide/steary erucamide/10094-45-8

Stearyl stearamide

Partition coefficient(log Kow)

Log Kow: > 5.7 at 23°C

Log Kow: 15.51 (QSAR)

Water solubility

Water solubility < 0.05 mg/L at 20°C and pH 6.4

Water solubility < 0.01 mg/L. (2.385E-011 mg/L, QSAR)

Biodegradability

RA from stearyl stearamide: Not readily biodegradable: 8-24 % after 28 days

Not readily biodegradable: 8-24 % after 28 days

Bioaccumulation

Low bioaccumulation potential (BCF = 0.89 - 3.16 L/kg wet-wt, QSAR)

Low bioaccumulation potential (BCF = 3.16 L/kg wet-wt, QSAR)

Environmental fate:

Release to the environment is limited, as the substance is highly insoluble in water and only limited concentrations of the substance will presumably be discharged to the aqueous/sediment compartment. Therefore the release to surface waters, and thereby exposure of sediment and soil, is considered as marginally as the substance is not bioavailable. However, if the substance is exposed to water, it will not evaporate into the atmosphere from the water surface because of its low vapour pressure and low Henry's Law Constant. Thus, air is not a likely route of environmental contamination and accumulation and subsequent deposition of (Z)-N-Octadecyldocos-13-enamide (CAS No. 10094-45-8) is not to be expected.

The substance is stable in water; hydrolysis is not expected to be an important process in the fate of (Z)-N-Octadecyldocos-13-enamide (CAS No. 10094-45-8). Bioaccumulation or biomagnification of the substance through the food chain is not expected.