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Product Name IMWITOR® 780 K
INCI Name Isostearyl Diglyceryl Succinate
Product Description:
IMWITOR® 780 K is a partial glyceride of isostearic and succinic acid. IMWITOR® 780 K is a clear, slightly yellowish liquid with a neutral odor.
Chemical and Physical Properties
Tests Value Unit
Acid Value 3 Max mg KOH/g
Saponification Value 240 – 260 mg KOH/g
Iodine Value <6 mg I2/100 g
Hydroxyl Value 100 – 120 mg KOH/g
Viscosity Value 2-° C 1.700 mPas
IMWITOR® 780 K is soluble in petroleum spirit, ethylalcohol, n-hexane, mineral oil, vegetable and animal fats and oils. IMWITOR® 780 K is insoluble in water, glycerin and propylene glycol.
IMWITOR® 780 K is a non-ionic w/o-emulsifier (HLB value: ∼3.7) without unsaturated components. W/O emulsions with high amounts of water can be prepared, especially when oleogels, such as MIGLYOL® gels, are used. In waterfree systems IMWITOR® 780 K increases the wetting, the capacity to absorb water and the wash-off ability.
IMWTOR® 780 K is particularly suitable for emulsifying highly polar oils, such as MIGLYOL® 812 and natural oils.
In waterless systems IMWITOR® 780 K increases the wetting, the capacity to absorb water and the wash-off ability.
Skin Sensitizing Properties of IMWITOR® 780 K and the relevance for classification & labeling
IMWITOR® 780 K has been used for almost 30 years as emulsifier in various applicatons, including cosmetic and pharmaceutical applications. No indications for sensitizing effects have been observed during that period. However, for regulatory purpose and general safety considerations a standard test to evaluate the skin sensitizing effects of IMWITOR® 780 K has been conducted in May 2007. The preferred test method nowadays to evaluate potential skin sensitizing effects is the Murine Local Lymph Node Assay (LLNA), although discussions are ongoing as to whether the test is suitable for all chemical groups. The LLNA is a reliable test for many substance classes, but conflicting results generated with surfactants and fatty acids lead to the belief that the LLNA has a tendency to overestimate sensitizing potentials, i.e. produce false positive results. However, restrictions due to animal welfare considerations limit the possibilities for comparative testing.
The LLNA test has been conducted according to OECD Guideline 429, following the principles of GLP, with IMWITOR® 780 K using 2 different evaluation methods [(i.e. (1) measurement of incorporation of H3-methyl thymidine and (2) cell counting instead of radioactive labeling (IMDS) to differentiate between irritating and sensitizing effects.] Test substance concentrations up to 50% have been used for the assay. With both evaluation methods, a very weak sensitizing effect of IMWITOR® 780 K was observed.
Despite the very weak effects from a regulatory perspective a classification as “skin sensitizer” (R-phrase R43) is required, since the EU classification and labeling scheme is purely hazard based.