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Final Report Plant-Derived Fatty Acid Oils As Used in Cosmetics March 4

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Final Report Plant-Derived Fatty Acid Oils As Used in Cosmetics March 4 Final Report Plant-Derived Fatty Acid Oils as Used in Cosmetics March 4, 2011 The 2011 Cosmetic Ingredient Review Expert Panel members are: Chair, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V. Belsito, M.D.; Ronald A Hill, Ph.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; James G. Marks, Jr., M.D.; Ronald C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The CIR Director is F. Alan Andersen, Ph.D. This report was prepared by Christina Burnett and Monice Fiume, Scientific Analysts/Writers, CIR. © Cosmetic Ingredient Review 1101 17 th Street, NW, Suite 412 " Washington, DC 20036-4702 " ph 202.331.0651 " fax 202.331.0088 " [email protected] TABLE OF CONTENTS Abstract ................................................................................................................................................................................................ 3 Introduction .......................................................................................................................................................................................... 3 Chemistry ............................................................................................................................................................................................. 3 Processing ........................................................................................................................................................................................ 4 Analytical Methods .......................................................................................................................................................................... 5 Impurities ......................................................................................................................................................................................... 5 Use ....................................................................................................................................................................................................... 6 Cosmetic .......................................................................................................................................................................................... 6 Non-Cosmetic .................................................................................................................................................................................. 7 Animal Toxicology .............................................................................................................................................................................. 7 Carcinogenicity .................................................................................................................................................................................... 7 Irritation and Sensitization ................................................................................................................................................................... 8 Dermal Effects ................................................................................................................................................................................. 8 Non-Human.................................................................................................................................................................................. 8 Human .......................................................................................................................................................................................... 8 Mucosal Irritation ............................................................................................................................................................................. 8 Non-Human.................................................................................................................................................................................. 8 Human .......................................................................................................................................................................................... 9 Clinical Use .......................................................................................................................................................................................... 9 Clinical Trials/Case Studies ............................................................................................................................................................. 9 Summary .............................................................................................................................................................................................. 9 Discussion .......................................................................................................................................................................................... 10 Conclusion ......................................................................................................................................................................................... 11 Figures and Tables ............................................................................................................................................................................. 14 Figure 1. General structure of fats and oils ................................................................................................................................... 14 Figure 2. Basic oil refinement flowchart ........................................................................................................................................ 15 Table 1. Plant-derived fatty acid oils. ............................................................................................................................................ 16 Table 2. Previously reviewed oil and fatty acid ingredients........................................................................................................... 19 Table 3. Chemical properties for plant-derived fatty acid oils. ..................................................................................................... 21 Table 4. Total fatty acid composition of plant-derived fatty acid oils (%)..................................................................................... 27 Table 5a. Frequency and concentration of use according to duration and exposure - ingredients not previously reviewed by the CIR ................................................................................................................................................................................................. 40 Table 5b. Current and historical frequency and concentration of use according to duration and type of exposure - previously reviewed ingredients ...................................................................................................................................................................... 51 Table 5c. Ingredients with no reported use concentrations or uses. .............................................................................................. 55 Table 6. Examples of non-cosmetic uses of oils. .......................................................................................................................... 56 Table 7a. Dermal effects – Non-Human studies ........................................................................................................................... 57 Table 7b. Dermal effects – Non-Human studies- – summarized from previous CIR reports ....................................................... 59 Table 8a. Dermal effects – Human studies .................................................................................................................................... 61 Table 8b. Dermal effects – Human studies – summarized from previous CIR reports .................................................................. 73 Table 9a. Ocular irritation – Non-Human and Human ................................................................................................................... 75 Table 9b. Ocular irritation – Non-Human - summarized from previous CIR reports ................................................................... 77 Table 10. Clinical Trials/Case Studies .......................................................................................................................................... 78 References .......................................................................................................................................................................................... 80 ii ABSTRACT The CIR Expert Panel assessed the safety of 244 Plant-Derived Fatty Acid Oils as used in cosmetics. Oils are used in a wide variety of cosmetic products for their skin conditioning, occlusive, emollient, and moisturizing properties. Since many of these oils are edible, and their systemic toxicity potential low, the review of the Panel focused on their potential dermal effects. The Expert Panel concluded that the 244 Plant-Derived Fatty Acid Oils are safe as used in cosmetics. INTRODUCTION Oils derived from edible vegetables, fruits, seeds, and tree and ground nuts have been safely consumed by humans for millennia. While nuts and some fruits and vegetables themselves may cause allergic reactions in certain individuals, the refined oils derived from these plants generally pose
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