Registration Dossier

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 an Alkyl phosphate and stearyl amine salts and is mainly composed by primary alkylamines (CAS 90640-32-7, UVCB), Monoalkyl dihydrogenophosphate and Dialkyl hydrogenophosphate salts (CAS 39471-52-8, Multi-Constituant). As the primary alkyl amine part is much more toxic than the The alkyl di/hydrogenophosphates 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 [former CAS-No. 61788-45-2,new 90640 -32 -7 ]), 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).