Registration Dossier
Registration Dossier
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EC number: 946-260-7 | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Data on toxicokinetics of the submission substance are not available. Default values based on physico-chemical information according to REACH Guidance are therefore used for the estimation of the kinetic profile. Based on the molecular mass of approximately 300 and a log Kow of 2.8 a default value of 100% is used for oral roue and an absorption rate of 60% as worst case consideration is taken for dermal absorption. Respiratory absorption, however, is considered to be negligible because the material is a solid wax with a very low vapour pressure and a moderate water solubility. Thus, significant exposure to vapours by inhalation is not to be expected.
Key value for chemical safety assessment
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 60
Additional information
Toxicokinetic data on the registration substance is not available. However, due to the close structural and functional similarities of fatty amine acetates with primary fatty amines, available information on alkylamines is used for ADME (absorption, distribution, metabolism and excretion) consideration of C12-18 -(even numberd, C18 -unsaturated)-alkylamines acetates.
However, using default values based on the physico-chemical properties of the alkylamines acetates, the amounts of absorption can be deduced for these substances. Based hereupon the following aspects can be considered. Primary alkyl amines are practically insoluble in water and calculated log Pow values for primary fatty amines are in the range between 7.1 and 7.7. With regard to potential inhalative exposure, a very low vapour pressure of the respective alkyl amines can be assumed. Taken together, based on physico-chemical properties, a low inhalative bioavailability can be anticipated. However, based on observed effects after oral exposure, as a worst-case, a value of 100 % oral absorption is taken. Based on the basicity and corrosive properties of most of the primary alkylamines, dermal absorption as a consequence of facilitated penetration through damaged skin can also be anticipated. Dependent on the solvent and concentration, up to 60 % dermal absorption may be taken as a worst case for assessment purposes (value taken from the existing EU risk assessment on primary alkylamines). Limited experimental data concerning toxicokinetic aspects which exist for major constituents of some of the primary fatty amines do support the view given above.
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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