Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 700-692-0 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
(Full justification for cross-reading can be found in the document attached to Chapter 13 of this IUCLID: "Category approach justification for polyamine acetates 29 03 2012.pdf".)
Data is based on read across from a structurally similar branched triamine C12. Branched triamine C16-18 (tallow) only differs in the length of the alkyl chain, which is suspected to influence aspects related to bioavailability, but not of chemical reactivity and route of metabolisation, that influence specific mechanisms of toxicity relevant for genotoxicity. For these reasons, many of the studies can be performed on the substance with the shortest chain length within a group of structurally similar substances, as this is considered to represent the most sensitive species to show specific effects.
The test substance was found non-mutagenic in a bacterial mutagenicity test (Ames test), performed in accordance with EU Method B.13/14 and under GLP, with Salmonella typhimurium strains TA 1535, TA 1537, TA100, TA98, and TA102 using test concentrations up to 200 μg/plate, both with and without metabolic activation (CIT, 2002d). The tests were performed up to cytotoxic levels. Two independent experiments were performed, using 3 plates per dose level. No increased number of revertants was observed in any experiment, indicating that the substance is not mutagenic in the Ames test.
As the acetate will dissociate from the substance during the process of absorption, there is no principal difference between systemic exposure to the polyamines acetate and the polyamine without the acetate. Consequently, cross-reading with the above mentioned study is applied for this endpoint to N-(3-aminopropyl)-NN-(C16-18 evennumbered, 18 unsaturated)-alkylpropane-1,3-diamine acetate. Additionally, polyamines do not react with DNA or react to protein (indicated by OECD Toolbox profiling).
Short description of key information:
All bacterial strains showed negative responses over the entire dose range, i.e. no significant dose-related increase in the number of revertants in two independently repeated experiments. The results are read acrossed from N-(3-aminopropyl)-N-tallow alkyl trimethylene diamine (N-(3-aminopropyl)-N-C12-18 alkyl trimethylene diamine, CAS#.85632-63-9. Read across is justified by structural similarities.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Available information from bacterial mutagenicity studies on the corresponding polyamine shows no signs of genotoxicity.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
