Supplement DEA CIR EXPERT PANEL MEETING JUNE 27-28, 2011 International journal of Toxicology 29(Supplement 3) 15lS-161S © The Author(s) 2010 Final Report of the Amended Safety Reprints and permission: sagepub.com/journalsPermissions.nav Assessment of Sodium Laureth DOl: 10.1 177/1091581810373151 http://ijt.sagepub.com Sulfate and Related Salts of Sulfated SAGE Ethoxylated Alcohols Valerie C. Robinson’, Wilma F. Bergfeld, MD, FACP2, Donald V. Belsito, , Ronald MD2 2, Curtis A. Hill, PhD D. Klaassen, PhD2, James G. Marks Jr, 2, 2, Shank, PhD MD Ronald C. Thomas 2, J. Slaga, PhD Paul W. Snyder, DVM, 2, and F. Alan PhD Andersen, PhD3 Abstract Sodium Iaureth sulfate is a member of a group of salts of sulfated ethoxylated alcohols, the safety of which was evaluated by the Cosmetic Ingredient Review (CIR) Expert Panel for use in cosmetics. Sodium and ammonium laureth sulfate have not evoked adverse responses in any toxicological testing. Sodium laureth sulfate was demonstrated to be a dermal and ocular irritant but not a sensitizer. The Expert Panel recognized that there are data gaps regarding use and concentration of these ingredients. However, the overall information available on the types of products in which these ingredients are used and at what concentrations indicates a pattern of use. The potential to produce irritation exists with these salts of sulfated ethoxylated alcohols, but in practice they are not regularly seen to be irritating because of the formulations in which they are used. These ingredients should be used only when they can be formulated to be nonirritating. Keywords cosmetics, safety, sodium laureth sulfate, salts of sulfated ethoxylated alcohols The Cosmetic Ingredient Review (CIR) Expert Panel previ acknowledged that although these ingredients can be eye and ously evaluated the safety of sodium myreth sulfate, with the skin irritants, they can be used safely in the practices of use and data myreth sulfate and 2”1 conclusion, based on for sodium concentration reported. sodium laureth sulfate, that sodium myreth sulfate is safe as cosmetic ingredient in the present practices of use and Sodium laureth sulfate and ammonium laureth sulfate are used a l57 concentration.1’ in cosmetic products as cleansing agents, emulsifiers, stabili zers, and solubilizers. The ingredients have been shown to pro Sodium myreth sulfate is the sodium salt of sulfated, ethoxylated duce eye andlor skin irritation in experimental animals and in myristyl alcohol which is used as a surfactant and cleansing some human test subjects; irritation may occur in some users agent in cosmetics at concentrations ranging from >1.0%-5.0% of cosmetic formulations containing the ingredients under con to >50.0%. A formulation containing 7.0% sodium myreth sul sideration. The irritant effects are similar to those produced by fate was shown to be an ocular irritant in experimental animals other detergents, and the severity of the irritation appears to and in some human test subjects. These irritant effects were sim increase directly with concentration. However, sodium and ilar to those previously reported for the chemically similar com ammonium laureth sulfate have not evoked adverse responses pound sodium laureth sulfate, which was shown to be safe for use in any other toxicological testing. On the basis of available in cosmetics. The report summarizes the safety test data on sodium laureth sulfate. Based upon the combined data cited in the report on both cosmetic ingredients, it is concluded that Cosmetic Ingredient Review Scientific Analyst/V’riter 2 sodium myreth sulfate is safe as a cosmetic ingredient in the pres Cosmetic Ingredient Review Expert Panel Member ent practices of use and concentration. Cosmetic Ingredient Review Director Corresponding Author: The reference to data for sodium laureth sulfate acknowledges Valerie C. Robinson, Cosmetic Ingredient Review, 1101 17th Street, NW, Suite an earlier safety assessment completed for ammonium laureth 412, Washington, DC 20036 sulfate and sodium laureth sulfate, in which the Expert Panel Email: cirinfo©cir-safety.org 152S International journal of Toxicology 29(Supplement 3) information, the panel concludes that sodium laureth sulfate No uses were reported under the VCRP for ammonium capry and arnmonium laureth sulfate are safe as presently used in leth sulfate, ammonium myreth sulfate, ammonium C12-15 cosmetic products. pareth sulfate, magnesium coceth sulfate, magnesium myreth sulfate, sodium Cl0-15 pareth sulfate, sodium C12-13 pareth In 2002, the CIR Expert Panel considered all available new sulfate, sodium laneth sulfate, sodium deceth sulfate, or zinc data on ammonium laureth sulfate and sodium laureth sulfate coceth sulfate. and reaffirmed that these ingredients are safe in the practices The reported use concentrations from a survey conducted by of use and concentration given.3 the Personal Care Products Council are shown in Table 2.6 No The CIR Expert Panel has further considered these related use concentrations were reported for ammonium myreth sulfate ingredients and determined that the data available for sodium and magnesium myreth sulfate. myreth sulfate and for both ammonium laureth sulfate and In some cases, ingredient uses were not reported to FDA in sodium laureth sulfate support the safety of a larger group of the VCRP; however, concentrations were provided to the Per chemically similar salts of sulfated ethoxylated alcohols. sonal Care Products Council. It should be presumed that there Accordingly, the CIR Expert Panel is amending both origi is at least 1 use in a product category if a use concentration is nal safety assessments to include ingredients.”2 other This reported in the industry survey. In other cases, the uses were report addresses the safety of the following ingredients: reported but no concentration was provided. In that case, it may be presumed that the use concentrations are similar to other use • Sodium myreth sulfate concentrations of related ingredients in that product category. • Ammonium capryleth sulfate As reported in the safety assessment of ammonium and • Ammonium C12-15 pareth sulfate sodium laureth sulfate, the laureth sulfate salts are used as • Arnmonium laureth sulfate shampoo, bath, and skin-cleansing ingredients, primarily • Arnmonium myreth sulfate because of both their high degree of foaming and detergency • Magnesium coceth sulfate and their “softness” to the 2 They skin. also function as emul • Magnesium laureth sulfate sifiers, stabilizers, and perfume solubilizers and are compatible • Magnesium myreth sulfate with nonionics, amides, amphoterics, and other anionic sys • Magnesium oleth sulfate tems. Their surface-active characteristics allow the laureth sul • Sodium Cl0-l5 pareth sulfate fates to be especially useful ingredients in products that require • Sodium Cl2-l3 pareth sulfate hard water tolerance and lime soap dispersing power. These • Sodium C12-15 pareth sulfate last characteristics increase with the degree of ethoxylation. • Sodium coceth sulfate • Sodium deceth sulfate • Sodium laneth sulfate • Sodium laureth sulfate Noncosmetic • Sodium oleth sulfate The anionic surfactants included in this report are generally • Sodium trideceth sulfate recognized for their thickening effect and ability to create • Zinc coceth sulfate lather; therefore, they have applications in industrial products including engine degreasers, floor cleaners, and car wash Chemistry soaps. Definition and Structure Table 1 presents synonyms, technical names, and trade names; New Safety Data chemical classes; definitions; and structures for each of the Ocular Irritation ingredients in this report as given in the International Cosmetic Ingredient Dictionary and HandbooJr.4 Tests were performed on ammonium alcohol ethoxy sulfate (the length of alkyl chain and degree of ethoxylation was not specified) in 10% and 20% concentrations of a liquid formula Use tion containing 9% active material. This substance was found Cosmetic to be nonirritating when instilled into the eyes of 20 human volunteers.7 Table 2 presents the available product use information pro vided by manufacturers to the US Food and Drug Administra tion (FDA) under the Voluntary Cosmetic Reporting Program (VCRP) for sodium myreth sulfate, ammonium laureth sulfate, M ucosal Irritation magnesium laureth sulfate, magnesium oleth sulfate, sodium When applied once daily for 2 weeks to male and female geni coceth sulfate, sodium C12-l5 pareth sulfate, sodium laureth talia, a 25% solution of a product containing 9% ammonium sulfate, sodium oleth sulfate, and sodium trideceth 5 sulfate. alcohol ethoxy sulfate was to 7 found be nonirritating. (continued) Mg 2 H 4 0GH2(OCH )OSO 3NH4 2GH(OGH )OSO 3NH4 Formula/Structure CH3(GH2)6GH(OGH)OSONH4 R(OCH 2GH)OSO 3N CH 3(GH 2) CH 3(GH 2)1 [R(OGH 2GH)OSO 3] 4. and the sulfate where sulfate the where to oil 4. CI2-15 formula and between to I 2-15 and the Cl represents I lauryl caprylyl to formula myristyl value formula R coconut polyethylene generally a the 4. synthetic the ethoxylated the generally between of 3. has and to from to where between n I of generally sulfated value ethoxylated a conforms ethoxylated a ethoxylated sulfated, represents value mixture It of value conforms of of derived of where R of a has generally It generally between n structure) of salt salt salt salt conforms salt average and groups average alcohol. where (see value that ether 4. an a an alcohols. structure) conforms conforms alkyl has and has has I Definition n Ammonium that (see Ammonium glycol