Registration Dossier
Registration Dossier
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EC number: 700-680-5 | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Short description of key information on bioaccumulation potential result:
The high molecular weight and the low water solubility of Isostearic acid, esters with methyl α-D-glucoside indicate a low potential for distribution through the human body.
Uptake via inhalation is anticipated to be low, because of the low vapour pressure and high molecular weight of the paste Isostearic acid, esters with methyl α-D-glucoside.
Test substance has no real potential for dermal absorption. 10% dermal absorption of Isostearic acid, esters with methyl α-D-glucoside is proposed for risk assessment purposes.
Key value for chemical safety assessment
Additional information
Isostearic acid, esters with methyl α-D-glucoside is a composition of 80% methyl glucoside isostearate esters (mainly di-), 16% Isostearic acid and 4% methyl glucoside.
The water solubility of Isostearic acid, esters with methyl α-D-glucoside is very low (5 x10E-4mg/L). Since in general a substance needs to be dissolved before it can be taken up from the gastrointestinal tract, it is unlikely that Isostearic 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 (average 726 g/mol) of this substance limiting the passage through biological membranes. Its highly Iipophilic character (log Pow > 6.5) indicates that uptake by micellular solubilisation may be of particular importance.
The results of the toxicity studies do not provide reasons to deviate from the proposed low oral absorption.
The high molecular weight and the low water solubility of Isostearic acid, esters with methyl α-D-glucoside indicate a low potential for distribution through the human body. Any substance absorbed from the gastrointestinal tract might undergo biotransformation. Excretion will be predominantly via the bile (high molecular weight substances).
Uptake via inhalation is anticipated to be low, because of the low vapour pressure and high molecular weight of the paste Isostearic acid, esters with methyl α-D-glucoside. The log Pow (>6.5) indicates a potential for absorption directly across the respiratory tract epithelium.
Isostearic acid, esters with methyl α-D-glucoside being a paste with a relatively high molecular weight has no real potential for dermal absorption. As the criteria for 10% dermal absorption as given in the TGD (ECB EU Technical Guidance Document on Risk Assessment, 2003) (MW > 500 and log Pow > 4) are met, 10% dermal absorption of Isostearic acid, esters with methyl α-D-glucoside is proposed for risk assessment purposes. The results of the toxicity studies do not provide reasons to deviate from this proposed dermal absorption factor.
Based on the present available data, no additional conclusions can be drawn on the distribution, metabolism and excretion of Isostearic acid, esters with methyl α-D-glucoside after dermal and inhalatory absorption.
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