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EC number: 701-138-0 | CAS number: 242482-67-3
No experimental data on toxicokinetics, metabolism and distribution of the submission substance are available. Based on the physicochemical properties of the submission substance it is anticipated that the substance is bioavailable via the oral, dermal or inhalation route. Beta oxidation or direct hydrolysis are thought to be reasonable metabolism pathways leading to systemic exposure to 3,5,5-trimethylhexanoic acid. Given the results from repeated dose experiments no concern for bioaccumulation is raised.
The submission substance is a 2,2',2''-nitrilotriethanol (TEA) salt of 6 -(isononanoylamino)hexanoic acid. A spontaneous conversion to acid is expected in aqueous system or in biological fluid. The relevant chemical species for uptake and systemic exposure is the acid. Thus the kinetic profile will be derived for 6 -(isononanoylamino)hexanoic acid.
- Beta oxidation at the terminal carboxylic acid moiety in combination with hydrolysis at amide bond
- Direct hydrolysis at the amide moiety
Both pathways are leading to systemic exposure to 3,5,5-trimethylhexanoic acid, which serves as surrogates of the proposed read-across approach.
The submission substance as well as the presumed metabolite 3,5,5-trimethylhexanoic acid caused effects on liver and kidney upon 28-day oral treatment in rats and these effects were fully reversible within recovery period of 14 days. No concern with respect to the bioaccumulation can be derived.
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.
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