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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Link to relevant study record(s)

Description of key information

Short description of key information on bioaccumulation potential result:

There are no toxicokinetic studies available with Amines, di-C16-18 (even-numbered) alkyl, CAS No. 308062-60-4, (DASA). The toxicokinetic fate has therefore been derived based on the physicochemical properties of the substance and from data on didecyldimethylammonium chloride, CAS No.7173-51-5 (DDAC), which is structurally similar to DASA. Overall, DASA is expected to be absorbed in the gastrointestinal tract only to a very limited extent and with corresponding poor tissue distribution. The most likely metabolic pathway and excretion data from DDAC supports a rapid elimination of DASA. Accordingly, bioaccumulation is not expected to occur.

Key value for chemical safety assessment

Bioaccumulation potential:
low bioaccumulation potential

Additional information

There are no toxicokinetic studies available with Amines, di-C16-18 (even-numbered) alkyl, CAS No. 308062 -60 -4 (DASA). Determination of toxicokinetic parameters are therefore based on the available physicochemical data for DASA and on read-across from didecyldimethylammonium chloride, CAS No.7173-51-5 (DDAC) for which a toxicokinetic study performed according to OECD guideline and under GLP conditions is available. A read-across from DDAC to DASA is considered justified as the common carbon chains will most likely be the main factor in determining the toxicokinetic parameters. Furthermore, as DASA is a weak base it will be protonated under the acidic conditions of the stomach. This will result in a net positive charge on the amine group similar to DDAC. Accordingly, these molecules are structurally similar and will have the same properties under relevant physiological conditions.

Absorption

Studies with DDAC demonstrated low absorption, <5% of administered dose, from the gastrointestinal tract. It can be expected that DASA will show similar absorption, or even less, as the carbon chains of DASA are significantly longer (C16-18) relative to DDAC (C10). The limited gastrointestinal absorption is also supported by the physicochemical data on DASA. With a molecular mass of greater than 500 and a calculated log Kowof 16.5, gastrointestinal absorption is expected to be low (Lipinski’s rule of 5). Absorption from lung is not considered relevant as the vapour pressure of DASA is low and no formation of aerosols is expected during manufacture and the use lifecycle of the substance.

 

Distribution

A wide distribution of DASA is not expected based on the studies with DDAC. The majority of DDAC is associated with intestines and with only very low levels found in central organs.

 

Excretion

Rapid excretion of DDAC has been observed, primarily via the feces. This is also expected for DASA. Bioaccumulation is not considered likely based on these findings.

 

Metabolism

The primary metabolic pathway for DASA is expected to be oxidation of the carbon chain as was observed with DDAC. Glucuronide and sulphate conjugation were also observed but only to a limited extent. The most likely metabolic transformations for DASA will all result in metabolites with increased solubility. This will further increase excretion and supports that bioaccumulation of DASA is unlikely.

 

Although no studies are available with DASA, the toxicokinetic fate has been derived based on the physicochemical properties of the substance and from data on DDAC, which is structurally similar to DASA. Overall, DASA is expected to be absorbed in the gastrointestinal tract only to a very limited extent and with corresponding poor tissue distribution. The most likely metabolic pathway and excretion data from DDAC supports a rapid elimination of DASA. Accordingly, bioaccumulation is not expected to occur.