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Administrative data

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Description of key information

No toxicokinetic studies are available for Stearic acid, esters with methyl α-D-glucoside.

Key value for chemical safety assessment

Additional information

No toxicokinetic studies are available for Stearic acid, esters with methyl α-D-glucoside. Assessment is based on available acute toxicity data, physicochemical properties and literature data and is developed with the aid of ECHA guidance on information requirements and chemical safety assessment chapter R7c.

Stearic acid, esters with methyl α-D-glucoside is a composition of approximately 80% methyl glucose stearate esters (mainly di-and tri-esters), 19% stearic acid and 2% methyl α-D-glucoside.

The water solubility of Stearic acid, esters with methyl α-D-glucoside is very low < 1 mg/L. Since in general a substance needs to be dissolved before it can be taken up from the gastrointestinal tract, it is unlikely that Stearic acid, esters with methyl α-D-glucoside will show a high systemic exposure after oral administration. The absorption will furthermore be lowered by the relatively high molecular weight of this substance limiting the passage through biological membranes. Its highly lipophilic character (log Pow > 7.67) indicates that uptake by micellular solubilisation may be of particular importance.

Dermal absorption is expected to be low, due to the high molecular weights associated with the most constituents of UVCB substance Stearic acid, esters with methylα-D-glucoside. Furthermore the substance must be sufficiently soluble in water to partition from the stratum corneum into the epidermis. Therefore, due to the water solubility of < 1 mg/L, the substance is expected to have a low potential for skin penetration.

In general, in humans, particles with aerodynamic diameters below 100 μm have the potential to be inhaled. Particles with aerodynamic diameters below 50μm may reach the thoracic region and those below 15μm the alveolar region of the respiratory tract.Inhalation is unlikely taking into account the very low vapour pressure of the substance and/or low likelihood of the generation of aerosols, particles or fine dusts of an inhalable size. Stearic acid, esters with methyl α-D-glucoside Inhalation is unlikely taking into account the very low vapour pressure of the substance and/or low likelihood of the generation of aerosols, particles or fine dusts of aninhalable size. Stearic acid, esters with methyl α-D-glucoside is a solid, marketed and used in form of Pellets about 5 - 8 mm in the diameter. Taking this consistence into account the generation of inhalable particles such as fine dust or aerosols is unlikely.

 

In conclusion the conducted studies with Stearic acid, esters with methyl α-D-glucoside, proof the absence of intrinsic toxicity. The substance does not need to be classified according to CLP, EU GHS (Regulation (EC) No 1272/2008). The toxicological profile is in agreement with the assumed low oral and dermal uptake of the substance.