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Safety Assessment of Fatty Acids & Fatty Acid Salts As Used in Cosmetics

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Safety Assessment of Fatty Acids & Fatty Acid Salts As Used in Cosmetics Safety Assessment of Fatty Acids & Fatty Acid Salts as Used in Cosmetics Status: Draft Final Report for Panel Review Release Date: March 15, 2019 Panel Meeting Date: April 8-9, 2019 The 2019 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 Executive Director is Bart Heldreth, Ph.D. This safety assessment was prepared by Christina L. Burnett, Senior Scientific Analyst/Writer. © Cosmetic Ingredient Review 1620 L St NW, Suite 1200◊ Washington, DC 20036-4702 ◊ ph 202.331.0651 ◊fax 202.331.0088 ◊ [email protected] Distributed for Comment Only -- Do Not Cite or Quote Commitment & Credibility since 1976 Memorandum To: CIR Expert Panel Members and Liaisons From: Christina L. Burnett, Senior Scientific Writer/Analyst Date: March 15, 2019 Subject: Draft Final Safety Assessment on Fatty Acids and Fatty Acid Salts Enclosed is the Draft Final Report of the Safety Assessment of Fatty Acids and Fatty Acid Salts as Used in Cosmetics. (It is identified as facids042019FR in the pdf document.) At the December 2018 meeting, the Panel issued a Tentative Report with the conclusion that 102 ingredients are safe in the present practices of use and concentration described in the safety assessment when formulated to be non-irritating and non-sensitizing, which may be based on a QRA. CIR staff have received the 2019 VCRP data and the use table for these ingredients has been updated accordingly. Only minor changes were noted. Linoleic Acid has increased from 633 to 681 total uses in cosmetic products; the majority of these uses are still in leave-on skin care products. Stearic Acid, a previously reviewed ingredient, still has the most reported uses of the ingredients in this safety assessment, with a total of 6265 (previously 5738); the majority of these uses are in leave-on eye makeup preparations and skin care products. Stearic Acid had a total of 2133 reported uses in 2006; the majority of the uses were also in leave-on eye makeup preparations and skin care products. Palmitic Acid, another previously reviewed ingredient, still has the second greatest number of reported uses in this safety assessment with 1532 (previously 1240); the majority of the uses were in leave-on eye makeup preparations and skin care products. In 2006, Palmitic Acid had a total of 132 reported uses; the majority of the uses were in rinse-off products such as shampoos, shaving products, and personal cleanliness products. Uses are now being reported for Sodium Undecylenate (1) and Ammonium Stearate (4), which previously did not have reported use. Additional data from the published literature, including short-term toxicity, chronic toxicity and genotoxicity studies on Isomerized Safflower Acid, a phototoxicity study on damaged skin following exposure to Linoleic Acid, and genotoxicity studies on Magnesium Stearate, have been incorporated into the report and highlighted for your convenience. No new data have been received from the Council since the December Panel meeting. Comments provided by the Council prior to the December meeting and on the Tentative Report have been addressed (facids042019pcpc1and facids042019pcpc2, respectively). In the comments on the Tentative Report, the Council states that conjugated linoleic acid (CLA; the technical name for Isomerized Safflower Acid) received a GRAS determination from the FDA in 2008. Upon further research, however, there is only a GRAS designation for methyl esters of CLA (21CFR 573.637). Staff have found no reliable evidence to demonstrate that the free acids have received GRAS status. The Panel should carefully review the Abstract, Discussion, and Conclusion of this safety assessment. If these are satisfactory, the Panel should issue a Final Report. __________________________________________________________________________________________ 1620 L St NW, Suite 1200, Washington, DC 20036 (Main) 202-331-0651 (Fax) 202-331-0088 (Email) [email protected] (Website) www.cir-safety.org Distributed for Comment Only -- Do Not Cite or Quote SAFETY ASSESSMENT FLOW CHART INGREDIENT/FAMILY _____ Fatty Acids and Fatty Acid Salts __________________________ MEETING ___April 2019 ___________________________________________________________ Public Comment CIR Expert Panel Report Status Priority List INGREDIENT PRIORITY LIST SLR Oct 2, 2018 DRAFT REPORT Dec 2018 Draft Report 60 day public comment period Table Table IDA TR IDA Notice IDA DRAFT TENTATIVE REPORT Draft TR Table Table Tentative Report Issue TR Jan 4, 2019 Draft FR DRAFT FINAL REPORT Apr 2019 60 day Public comment period Table Table Different Conclusion Issue PUBLISH Final Report FR Distributed for Comment Only -- Do Not Cite or Quote Fatty Acids and Fatty Acid Salts History October 2, 2018 - Scientific Literature Review announced. December 4, 2018 - The Panel issued a tentative report with the conclusion that the 102 ingredients are safe in the present practices of use and concentration described in the safety assessment when formulated to be non-irritating and non-sensitizing, which may be based on a QRA. The Expert Panel recognized that these ingredients, particularly Myristic Acid, Oleic Acid, and Sodium Caprate, can enhance the penetration of other ingredients through the skin. The Panel cautioned that care should be taken in formulating cosmetic products that may contain these ingredients in combination with any ingredients whose safety was based on their lack of dermal absorption data, or when dermal absorption was otherwise a concern. The Panel was concerned that the potential exists for dermal irritation with the use of products formulated using fatty acids and fatty acid salts. The Panel specified that products containing fatty acids and fatty acid salts must be formulated to be non- irritating. The Panel was also concerned about the potential for polyunsaturated fatty acids to undergo oxidation during the formulation, or storage of cosmetic products, that may produce compounds that are dermal sensitizers. The Panel advises industry to limit oxidative products in formulations containing fatty acids and fatty acid salts, and to utilize accepted methodologies, such as a QRA, to ensure formulations are non- sensitizing. Distributed for Comment Only -- Do Not Cite or Quote Fatty Acids and Fatty Acid Salts Data Profile –April 2019 – Writer, Christina Burnett Nonhuman Human - - Use - In Physical/Chemical Properties Method of Manufacturing Composition/Impu rities UV Absorption Toxicity Acute Dose Repeated Toxicity Genotoxicity Reproductive and Developmental Carcinogenicity Irritation/Sensitiza tion Irritation/Sensitiza tion Ocular/Mucosal Clinical/Case Studies Toxicokinetics Phototoxicity Aluminum Dilinoleate Aluminum Distearate X X * * Aluminum Isostearate Aluminum Isostearates/Palmitates Aluminum Isostearates/Stearates Aluminum Isostearates/ Laurates/Palmitates Aluminum Isostearates/ Laurates/Stearates Aluminum Lanolate Aluminum Stearate X X * Aluminum Stearates X Aluminum Tristearate X X X Ammonium Isostearate Ammonium Oleate X X X X Ammonium Stearate X X * * * * Arachidic Acid X X Beeswax Acid X Behenic Acid X X X X X X X C14-28 Alkyl Acid X C10-40 Isoalkyl Acid X C14-28 Isoalkyl Acid X C32-36 Isoalkyl Acid Calcium Behenate X Calcium Laurate Calcium Stearate X X X X X* X X * Calcium Undecylenate X Capric Acid X X X X X X X Distributed for Comment Only -- Do Not Cite or Quote Fatty Acids and Fatty Acid Salts Data Profile –April 2019 – Writer, Christina Burnett Nonhuman Human - - Use - In Physical/Chemical Properties Method of Manufacturing Composition/Impu rities UV Absorption Toxicity Acute Dose Repeated Toxicity Genotoxicity Reproductive and Developmental Carcinogenicity Irritation/Sensitiza tion Irritation/Sensitiza tion Ocular/Mucosal Clinical/Case Studies Toxicokinetics Phototoxicity Caproic Acid X X X X X Caprylic Acid X X X X X X X X Dilinoleic Acid X X Dierucic Acid Eicosatrienoic Acid X Erucic Acid X Hydroxycapric Acid X X Hydroxycaprylic Acid X X 10-Hydroxydecanoic Acid X X Hydroxylauric Acid X Hydroxystearic Acid X X * * * * X * X 10-Hydroxystearic Acid X * Isomerized Linoleic Acid X X X X Isomerized Safflower Acid X X Isostearic Acid X X * * X* * * * Lauric Acid X X * X X* * X* * * * X* * X* X Linoleic Acid X X X X X X X Linolenic Acid X X X Lithium Stearate X X X* X X X X X Magnesium Lanolate Magnesium Laurate X Magnesium Palmitate X Magnesium Stearate X X X * *X * * * * Magnesium Tallowate Myristic Acid X X * X X * * * * * Methyl Myristic Acid X Oleic Acid X X * X * * * * * X* X* * X* * Palmitic Acid X X * X X* * * * * X* X* X* * Distributed for Comment Only -- Do Not Cite or Quote Fatty Acids and Fatty Acid Salts Data Profile –April 2019 – Writer, Christina Burnett Nonhuman Human - - Use - In Physical/Chemical Properties Method of Manufacturing Composition/Impu rities UV Absorption Toxicity Acute Dose Repeated Toxicity Genotoxicity Reproductive and Developmental Carcinogenicity Irritation/Sensitiza tion Irritation/Sensitiza tion Ocular/Mucosal Clinical/Case Studies Toxicokinetics Phototoxicity Potassium Behenate X Potassium Borageate Potassium Camelliate Potassium Caprate Potassium Caprylate Potassium Caprylate/Caprate Potassium Castorate X Potassium Hydrogenated X Tallowate Potassium Hydroxystearate Potassium Isostearate X Potassium Lanolate Potassium Laurate X X Potassium Linoleate X Potassium
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