Amended final report on the safety assessment of Glyceryl Dilaurate, Glyceryl Diarachidate, Glyceryl Dibehenate, Glyceryl Dierucate, Glyceryl Dihydroxystearate, Glyceryl Diisopalmitate, Glyceryl Diisostearate, Glyceryl Dilinoleate, Glyceryl Dimyristate, Glyceryl Dioleate, Glyceryl Diricinoleate, Glyceryl Dipalmitate, Glyceryl Dipalmitoleate, Glyceryl Distearate, Glyceryl Palmitate Lactate, Glyceryl Stearate Citrate, Glyceryl Stearate Lactate, and Glyceryl Stearate Succinate
Glyceryl Dilaurate, Glyceryl Diarachidate, Glyceryl Dibehenate, Glyceryl Dierucate, Glyceryl Dihydroxystearate, Glyceryl Diisopalmitate, Glyceryl Diisostearate, Glyceryl Dilinoleate, Glyceryl Dimyristate, Glyceryl Dioleate, Glyceryl Diricinoleate, Glyceryl Dipalmitate, Glyceryl Dipalmitoleate, Glyceryl Distearate, GlycerylPalmitate Lactate, Glyceryl Stearate Citrate, Glyceryl Stearate Lactate, and Glyceryl Stearate Succinate are diacylglycerols ( also known as diglycerides or glyceryl diesters) that function as skin conditioning agents-emollients in cosmetics. Only Glyceryl Dilaurate (up to 5%), Glyceryl Diisostearate (up to 43%), Glyceryl Dioleate (p to 2%), Glyceryl Distearate (up to 7%), and Glyceryl Stearate Lactate (up to 5%) are reported to be in current use. Production proceeds from fully refined vegetable oils, which are further processed using hydrogenation and fractionation techniques, and the end products are produced by reacting selected mixtures of the partly hydrogenated, partly fractionated oils and fats with vegetable-derived glycerine to yield partial glycerides. In the final stage of the production process, the products are purified by deodorization, which effectively removes pesticide residues and lower boiling residues such as residues of halogenated solvents and aromatic solvents. Diglycerides have been approved by the Food and Drug Administration ( FDA) for use as indirect food additives. Nominally, these ingredients are 1,3-diglycerides, but are easily isomerized to the 1,2-diglycerides form. The 1,3-diglyceride isomer is not a significant toxicant in acute, short-term, subchronic, or chronic animal tests. Glyceryl Dilaurate was a mild primary irritant in albino rabbits, but not a skin sensitizer in guinea pig maximization tests. Diacylglycerol Oil was not genotoxic in the Ames test, in mammalian Chinese hamster lung cells, or in a rodent bone marrow micronucleus assay. An eye shadow containing 1.5% Glyceryl Dilaurate did not induce skin irritation in a single insult patch test, but mild skin irritation reactions to a foundation containing the same concentration were observed. A trade mixture containing an unspecified concentration of Glyceryl Dibehenate did not induce irritation or significant cutaneous intolerance in a 48-h occlusive patch test. In maximization tests, neither an eye shadow nor a foundation containing 1.5% Glyceryl Dilaurate was a skin sensitizer. Sensitization was not induced in subjects patch tested with 50% w/w Glyceryl Dioleate in a repeated insult, occlusive patch test. Glyceryl Palmitate Lactate ( 50% w/v) did not induce skin irritation or sensitization in subjects patch tested in a repeat-insult patch test. Phototoxicity or photoallergenicity was not induced in healthy volunteers tested with a lipstick containing 1.0% Glyceryl Rosinate. Two diacylglycerols, 1-oleoyl-2-acetoyl-sn-glycerol and 1,2-dipalmitoyl-sn-glycerol, did not alter cell proliferation ( as determined by DNA synthesis) in normal human dermal fibroblasts in vitro at doses up to 10 mu g/ml. In the absence of initiation, Glyceryl Distearate induced a moderate hyperplastic response in randomly bred mice of a tumor-resistant strain, and with 9,10-dimethyl-1,2-benzanthracene ( DMBA) initiation, an increase in the total cell count was observed. In a glyceryl monoester study, a single application of DMBA to the skin followed by 5% Glyceryl Stearate twice weekly produced no tumors, but slight epidermal hyperplasia at the site of application. Glyceryl Dioleate induced transformation in 3-methylcholanthrene-initiated BALB/3T3 A31--1 cloned cells in vitro. A tumor-promoting dosing regimen that consisted of multiple applications of 10 mu mol of a 1,2-diacylglycerol ( sn-1,2-didecanoylglycerol) to female mice twice daily for 1 week caused more than a 60% decrease in protein kinase C ( PKC) activity and marked epidermal hyperplasia. Applications of 10 mu mol sn-1,2-didecanoylgly
