Registration Dossier
Registration Dossier
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EC number: 203-756-1 | CAS number: 110-31-6
Endpoint summary
Administrative data
Description of key information
Additional information
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, information shall be generated whenever possible by means other than vertebrate animal tests, through the use of alternative methods, for example, in vitro methods or qualitative or quantitative structure-activity relationship models or from information from structurally related substances (grouping or read-across).” According 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, substances may be considered as a group provided that their physicochemical and toxicological are likely to be similar or follow a regular pattern as a result of structural similarity. The substances within the analogue approach are considered to apply to these general rules, and the similarity is justified on basis of scope of variability and overlapping of composition, representative molecular structure, physico-chemical properties and toxicological profiles. There is convincing evidence that these chemicals lie in the overall common profile of this analogue approach.
This read across is justified in detail in the analogue justification in IUCLID Section 13.
Abiotic degradation
No experimental data are available for the target and the source substance regarding abiotic degradation in the environment. Due to the highly insoluble nature of both substances (< 0.01 mg/L), no testing for hydrolysis is required. Abiotic degradation is considered to be not a relevant pathway for the target and the source substance.
The source and the target substances are susceptible to indirect phototransformation in air with half-lives (DT50 values) ranging from 1.23 h to 5.94 h.
However, due to the low vapour pressure and a Henry’s Law Constant ranging from 0.00487 to 0.0363 Pa m³/mol for both substances evaporation to the atmosphere is unlikely. Thus, air is not a likely route of environmental contamination and no accumulation and subsequent deposition of the substance is to be expected.
Biodegradation
No study investigating the biodegradation behaviour of the target substance Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis is available. Therefore, read-across based on the analogue approach from the structurally related source substance Amides, C16-C18 (even), N,N'-ethylenebis is conducted.
The source substance only attained <16% (CO2 evolution) after 28 d according to the OECD 301B criteria in one reliable GLP-Guideline study (Coenen, 1991). In a supporting study the source substance attained only 1.1% (O2 consumption) (MITI, 1976). Therefore the source substance is considered to be not readily biodegradable.
Based on the available data on the structurally related source substance, the target substance Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis is considered to be not readily biodegradable, either.
Bioaccumulation
No study investigating the bioaccumulation behaviour of the target substance Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis is available. One study investigating the bioaccumulation potential of the structurally related source substance Amides, C16-C18 (even), N,N'-ethylenebis is used to cover this endpoint. Both substances have a Kow of > 10, this indicates a potential for bioaccumulation. However, substances with high log Kow values have a lower potential for bioconcentration as summarized in the ECHA Guidance R.11 (ECHA, 2012).
The bioaccumulation behaviour of the source substance was investigated according to “Circular on the Japanese Test Methods of New Chemical Substances, bioaccumulation test” (MITI, 1988). The BCF values were estimated to be < 0.7 at a concentration of 0.830 mg/L and < 6.2 at a concentration of 0.083 mg/L.
Based on the available data on the structurally related source substance, the target substance Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis is considered to have no bioaccumulation potential, either.
Adsorption (LogKoc)
Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis and Amides, C16-C18 (even), N,N'-ethylenebis are expected to adsorb to suspended solids and sediment based upon a measured log Koc of > 5. The adsorption coefficient has been determined to be greater than 4.27E5 (log Koc > 5.6) using the HPLC screening method according to OECD 121. The test substance is highly insoluble in water, and due to the low water solubility of the test substance in the chromatogram of the test solution no test substance peak was observed. Additional information could be gathered using the program EpiSuite (KOCWIN v2.00), log Koc values of the three components for the target substance ranging from 7.89 to 9.95 (MCI method) were calculated.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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