Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Based upon the physico-chemicals and toxicological properties of the test material and the read across substance there is no / low bioaccumulation potential.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

The substance is a non-volatile solid block.

- Oral route:
The registered substance has a high molecular weight and Log Kow, and low water solubility. Micellular solubilisation is therefore the likely mechanism for absorption following an exposure via the oral route.
Experimental data showed a lack of significant systemic effects following an acute or repeated exposure via the oral route. Consequently, these data do not allow determining if the substance was absorbed.
Simulation of the acidic and basic hydrolysis of the compound using the QSAR ToolBox 4.4.1, indicated that its constituents can be expected to be broken into their individual amine and fatty acid (see ‘Metabolisation’). However, this hydrolysis process is expected to be limited due to the substance being highly insoluble in water.
- Inhalation:
There is no data available on the inhalation route of exposure for the substance. Inhalation is an unlikely route of exposure, considering the substance is a solid block with a low vapour pressure.
- Dermal route:
There is no data available on the dermal route of exposure for the substance. Dermal exposure cannot be excluded but is not the most relevant route of exposure.
The substance being a solid at room temperature, it would have to dissolve in contact with skin moisture before skin penetration. However, it is highly insoluble in water, so this process would be very limited. Molecular weight is between 480 and 535, which is not favourable for absorption through the skin. In addition, it is very lipophilic. As a result, dermal absorption can reasonably be expected to be inconsequential.

Considering the high log Kow of the substance, it can be expected to be distributed in particular in fatty tissues, and has the potential to accumulate into the body.
Experimental data available on the registered substance do not allow to identify likely target organs.

There are no experimental data on metabolism.
Metabolisation is expected to happen by breaking the amide bond between the fatty acid and amine. This process may happen through enzymatic hydrolysis, notably with Fatty Acid Amide Hydrolases (FAAH), which are distributed within the body, in particular in small intestine, liver, kidney and brain. These first metabolites are therefore expected to be saturated C16 to C18 fatty acids and saturated C16 to C18 amines. Resulting fatty acids will mainly be metabolised through beta-oxidation, ultimately leading to the production of water and carbon dioxide. Omega-oxidation was identified as an alternative metabolisation pathway for fatty acids when beta-oxidation is blocked/saturated. The fatty acids can also be conjugated to form more polar products that are easily excreted in the urine. The amines may be oxidatively deaminated by mono amino oxidases to release the corresponding aldehyde and ammonia. The aldehyde may be further oxidised via the enzymatic action of aldehyde dehydrogenase to the corresponding carboxylic acid, which may be fed into further metabolic pathways such as beta-oxidation. Ammonia released by the deamination of the chemicals can be converted into urea in the liver.

No observations on excretion were noted in the results from available studies. Final metabolites for the substance will be excreted as water and carbon dioxide. Ammonia released for the amine part will be either reabsorbed in the kidneys or eliminated through urine.