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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Additional information

Inhalation absorption

The potential for dust inhalation is considered to be of no relevance, since the substance at room temperature (20-25°C) is a liquid to waxy solid and not a powder with an inhalable size.Taking into account the vapour pressure of 3*10-5Pa at 25°C of SymMollient®S and the low water solubility(A: 3.5 µg/L/ B: 1.7 µg/L) inhalation of vapours can also be completely ruled out.

 

Oral absorption

SymMollient® S is of low water soluble (A: 3.5 µg/L/ B: 1.7 µg/L) and highly lipophilic (log Pow (calculated) = 11.2 / 12.2), therefore absorption may be limited by the lowability to dissolve in GI fluids and hence to be available in soluble form at the mucosal surface. However, the absorption will be enhanced if they undergo micellular solubilisation by bile salts.

Dermal absorption

SymMollient® S is intended to be used at a low application rate as a topical skin care product to regulate the moisture content of the skin by forming alight hydrophobic film on the skin that protects from drying out.

 

Based on the low water solubility (A: 3.5 µg/L/ B: 1.7 µg/L) and the high lipophilicity (logPow (calculated) = 11.2 / 12.2), quantitatively relevant dermal absorption cannot completely ruled out on the basis of theoretical considerations only.

 

Distribution

The substance is expected to reach the systemic circulation only to a very limited extend and in addition it is expected to be readily metabolised after passing the liver. Therefore, distribution SymMollient® S throughout the body is not very likely.

Metabolism and elimination

The carboxylesterase hydrolyses the carboxylic esters into a carboxylate and alcohol.

The alcohol will be oxidised in the liver to an aldehyde, catalysed by the alcohol/dehydrogenase containing the coenzyme NAD+. The aldehyde is further oxidised to the respective carboxylate. Both carboxylates will be broken down into acetyl-CoA-units, which will be metabolised in the citrate cycle just like the conventional metabolism of natural fatty acids, ultimately yielding carbon dioxide as respiration product.

In consequence, if small amounts of SymMollient® S reach the systemic circulation, the substance may be expected to be readily biotransformed to harmless, endogenous cellular constituents of the energy-producing metabolic pathway.