Registration Dossier
Registration Dossier
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EC number: 204-693-2 | CAS number: 124-26-5
Endpoint summary
Administrative data
Description of key information
Additional information
Data about the mono-constituent stearamide are not available. Stearamide is an amide of stearic acid with a purity of more than 80%, containing also a fraction of palmitamide (amide of palmitic acid). In the fatty acid nomenclature, these fatty acids are denoted C18 and C16, respectively, due to the length of their carbon chains. The read across substance Amides, C16-18 (even numbered) differs from the target only in composition (< 80% C18), it is an UVCB mixture containing also primarily palmitamide (CAS No. 629-54-9) and stearamide (CAS No. 124-26-5). For decades, stearamide and Amides, C16-C18 (even numbered) have been considered as different purity grades of the same substance and have been marketed as stearamide (CAS 124-26-5). Due to the conventions laid down in the "Guidance for identification and naming of substances under REACH and CLP" these different purity grades now have to be considered as different substances and are subject to separate registrations. It is therefore considered valid to read-across the results for Amides, C16-18 (even numbered) to fill the data gap for the registered substance.
Further, information for erucamide was also used as read across. Erucamide (CAS 112-84-5), is the fatty acid amide resulting from the amidation of erucic acid. Erucic acid is a mono-unsaturated fatty acid with a carbon chain consisting of 22 carbon atoms with a double bond at position 13 (omega-9) of the carbon chain (cis-docos-13-enoic acid).
Additional information is given in a justification for analogue approachattached in Section 13 of the IUCLID 5 dossier.
Short term tests with species of 3 trophic levels are available for Amides, C16-18 (even numbered) and based on this tests, the substance can be regarded as acutely not harmful to aquatic organisms. Short term toxicity data of the substance towards fish, daphnia and algae give a NOEC greater than the water solubility of stearamide. No toxicity could be observed in any test. Additionally, long term test with the structural related erucamide are conducted. The available study report on long-term toxicity of erucamide to fish conducted according to OECD 215 demonstrate no effect up to the limit of the water solubility of the tested substance. The same applies for a long term daphnia study according to OECD 202 for erucamide, detecting no effects up to the limit of the water solubility of the tested substance. Furthermore the inhibition of the degradation activity of activated sludge is not anticipated.
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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