Registration Dossier
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EC number: 233-226-5 | CAS number: 10094-45-8
Toxicity to terrestrial arthropods
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
Experimental data on the toxicity of (Z)-N-Octadecyldocos-13-enamide (CAS No. 10094-45-8) to terrestrial arthropods are not available.
The substance is characterised by a high log Koc (log Koc > 5) indicating a considerable potential for adsorption to the soil particles but as the substance is highly insoluble in water (< 0.01 mg/L), only low concentrations are expected in the pore water. Therefore, tests with soil-dwelling organisms like earthworm which allows potential uptake via surface contact, soil particle ingestion and porewater (ECHA, 2012), are most relevant for the evaluation of soil toxicity. In addition, in the absence of a clear indication of selective toxicity, an invertebrate (earthworm or collembolan) test is preferred, as outlined in ECHA guidance section R.7.11.5.3, page 122. Thus, it can be assumed that earthworms would be highly exposed to toxicants in soil and hence are most sensitive to the potential adverse effects of the substance.
In accordance with Regulation (EC) No 1907/2006, Annex XI, Section 1.5 a read across to the structurally similar analogue substance (Z)-N-octadec-9-enylhexadecan-1-amide (oleyl palmitamide, CAS 16260-09-6) will be conducted to fulfill the data requirements according to Annex IX of (Z)-N-Octadecyldocos-13-enamide (CAS No. 10094-45-8) in regard to long-term toxicity to soil macroorganisms. This read across is justified in detail in the analogue justification in IUCLID Section 13.
The study is not yet available since a testing proposal according to OECD 222 was submitted for the read-across substance (Z)-N-octadec-9-enylhexadecan-1-amide (oleyl palmitamide, CAS 16260-09-6). However, no additional test with soil macroorganisms will be proposed for (Z)-N-Octadecyldocos-13-enamide (CAS No. 10094-45-8). The PNECsoil will be calculated using long term toxicity data to earthworms giving a robust PNECsoil for the chemical safety assessment. . For the revision of the chemical safety assessment, the PNEC as well as PEC values will be evaluated critically, as soon as the result of the Earthworm Reproduction test is available. We will demonstrate that the PEC/PNECsoil is < 1, i.e. no indication of risk from the confirmatory long-term soil toxicity testing to earthworms. Thus, no further toxicity testing for soil organisms needs to be done.
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