Registration Dossier
Registration Dossier
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EC number: 800-984-9 | CAS number: 1428547-35-6
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
There are no specific studies available on absorption, distribution, metabolism or excretion of the registered substance. Assessment of toxicokinetic properties is based on the physico-chemical properties and experimental data of primary alkylamine compounds.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 60
- Absorption rate - inhalation (%):
- 100
Additional information
The registered substance is a salt composed of primary hydrogenated alkylamine and N-hydrogenated tallow fatty acid. As the primary alkyl amine part is much more toxic than the tallow fatty acid part, it is expected that the toxicological behaviour of the substance will not be far different from that of the primary alkylamine compounds or at least not more severe than the latter in view of its low release . Thus, data of primary alkylamines can be used as read-across.
C16 -18 -(even numbered)-alkylamines (common name: Hydrogenated tallow alkyl amines [CAS-No. 61788-45-2]), C16 -18 -(even numbered, C18 -unsaturated)-alkylamines (common name: Tallow alkyl amines [CAS-No. 61790-33-8]), C16 -18 -(even numbered, saturated and unsaturated)-alkylamines (common name: (Z)-octadec-9-enylamines [CAS-No. 112-90-3]), octadecylamines [CAS-No. 124-30-1] and C12-18-(even numbered)-alkylamines (common name: Coco alkyl amines [CAS-No. 61788-46-3]) are considered as a chemical category. No toxicokinetic data are available for this chemical category. However, physico-chemical properties and experimental data exist for major constituents of the chemical category which allow basic considerations concerning toxicokinetic parameters like absorption and metabolism.. 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 (far below 0.1 hPa) 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 the absence of quantitative data and the 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).
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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