Ingredient AMINE OXIDES IN COSMETIC SYSTEMS 165 Table VIII Skin Lotion Formulation for Irritation Studies Control 2000 ppm quat Per Cent Mineral oil 35.0 35.0 Cetyl alcohol 1.0 1.0 Lanolin 1.0 1.0 C•DMAO 2.5 2.5 Quaternary (100%) 0.2 Water 6'0'.• 60.3 Total 100.0 100.0 Table IX Eye Irritation Results for Control System (No Quat) Days After Installation i 2 3 4 7 I. Cornea A. Opacity 0 0 0 0 0 B. Area of cornea involved 0 0 0 0 0 Score=A X B X 5max=80 0 X0 X 5=0 II. Iris A. Values 0 0 0 0 0 Score ----- A X 5max=10 0 X 5=0 III. Conjunctivae A. Redness 0 0 0 0 0 B. Chemosis 0 0 0 0 0 C. Discharge 0 0 0 0 0 Score= (AXB XC) X2max=20 (0q-0q-0) X 2=0 _ 72 hours, although no edema formation was noted, giving a primary irrita- tion score of 4. With quaternary, there was erythema and eschar formation after 24 and 72 hours, and edema formation on intact and abraded skin after 24 hours, giving a primary skin irritation score of 6. Further toxicological tests led us to the conclusion that mineral oil by it- self was the cause of this irritation. The lotion was then remade, unpreserved and preserved, with 2000 ppm ouat, using an ester, isopropyl palmitate, in place of the mineral oil (Table XII ). Results of skin irritation testing using this system showed no irritation at all on intact or abraded skin (Table XIII ). Also, eye irritation testing accord- ing to the Draize Method indicated that the product with isopropy! palmitate was not an irritant either with or without quaternary.

166 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS Table X Eye Irritation Results for System with 2000 Quaternary Days After Installation 1 9. 3 4 7 I. Cornea A. Opacity 0 B. Area of cornea involved 0 Score•- A X B X 5max=80 II. Iris A. Values o Score=A X 5max=10 III. Conjunctivae A. Redness 1 B. Chemosis 0 C. Discharge 0 Score=(Ax BX C) xgmax=20 o o o o o o 0•0XS=0 o o o 0X5=0 o o o o o o o o o (l+o+o) x9.=2 Table XI Results of Primary Skin Irritation Studies Av. Exposure Value Exposure Time (Hours) No Quat 2000 ppm Quat Erythema and eschar formation Intact skin Abraded skin Edema formation Intact skin Abraded skin Subtotal Subtotal Primary irritation 24 1 1 72 1 1 24 1 1 72 1 1 4 4 24 72 24 72 0 1 o o o 1 0 0 0 2 4 6 Commercially available stearyl dimethyl amine oxide of good quality, namely that containing low peroxide and free amine (Atomonyx SO), was tested by itself at 5% active for skin and eye irritation. These results indi- cated that this material is neither a primary skin irritant nor an occular irri- tant.