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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Reference
Endpoint:
basic toxicokinetics, other
Type of information:
other: Expert statement
Adequacy of study:
key study
Study period:
2013
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: All available information on physical, chemical and toxicological properties were evaluated.
Conclusions:
No bio-accumulation expected. The test item is expected to be bioavailable via oral and dermal routes and distributed throughout the organism. Significant metabolism is anticipated due to the similarity to fatty acids. Excretion of degradation products via kidneys and lungs (CO2) is also expected.
Executive summary:

Humectol C is produced and handled as a reaction mass of sodium hydrogen N,N-dibutyl-10-(sulphonatooxy)-octadecane-amidate and sodium sulpho-octadecanoate containing at least 47 components. None of these components is present at more than 5 %. The structures are mainly sulfated fatty acid (saturated as well as unsaturated) and sulfated fatty acid amides with secondary amine moieties. The molecules are supposed to have a variable structures made of long non-polar chains with polar groups (sulfate, carboxylate, carbamide) attached. Sulfate-cross-linked material is also present. The molecular weight of this material is mostly between 250 and ca. 800 Dalton.

Absorption: Humectol C is soluble in water up to 2.99 g/L and the organic chains will lead to a significant solubility in lipids. Therefore, at least the smaller and non-polar molecules are expected to be readily bio-available through the skin as well as after oral exposure Depending on the number of sulfate moieties in the molecules the absorption might, however, be compound- and route-specifically variable.

Distribution: After absorption distribution throughout the organism is expected. A specific potential for accumulation in e. g. fatty tissue is not anticipated due to the possible degradation and the polar groups in most of the involved compounds.

Metabolism: Humectol C has mostly a molecular weight below 800 Dalton and is quite soluble at physiologic pH. The molecular structures resemble fatty acids and amides. These structures are expected to be accessible to biotransformation and degradation by hydrolysis and oxidation. Parts of the fatty acid chains might be introduced to the normal fat metabolism.

Elimination: As Humectol C is expected to become available to metabolism and transport in a living organism, it is expected to degrade to carbon dioxide, water, sulfate and nitrogen compounds. Carbon dioxide will be exhaled and the other products are likely to be excreted via the normal excretory organs (kidney or liver/gall bladder). If applied orally some of the material may be eliminated via the feces.

Description of key information

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

Absorption: Humectol C is soluble in water up to 2.99 g/L and the organic chains will lead to a significant solubility in lipids. Therefore, at least the smaller and non-polar molecules are expected to be readily bio-available through the skin as well as after oral exposure Depending on the number of sulfate moieties in the molecules the absorption might, however, be compound- and route-specifically variable.

Distribution: After absorption distribution throughout the organism is expected. A specific potential for accumulation in e. g. fatty tissue is not anticipated due to the possible degradation and the polar groups in most of the involved compounds.

Metabolism: Humectol C has mostly a molecular weight below 800 Dalton and is quite soluble at physiologic pH. The molecular structures resemble fatty acids and amides. These structures are expected to be accessible to biotransformation and degradation by hydrolysis and oxidation. Parts of the fatty acid chains might be introduced to the normal fat metabolism.

Elimination: As Humectol C is expected to become available to metabolism and transport in a living organism, it is expected to degrade to carbon dioxide, water, sulfate and nitrogen compounds. Carbon dioxide will be exhaled and the other products are likely to be excreted via the normal excretory organs (kidney or liver/gall bladder). If applied orally some of the material may be eliminated via the feces.