Source Amino Acids as Used in Cosmetics

Transcription

1 Scientific Literature Review Source Amino Acids as Used in Cosmetics May 23, 2012 The 2012 Cosmetic Ingredient Review Expert Panel members are: Chairman, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V. Belsito, M.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; Ronald A. Hill, 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 L. Burnett, Scientific Analyst/Writer, and Bart Heldreth, Ph.D., Chemist CIR. Cosmetic Ingredient Review th Street, NW, Suite 412 " Washington, DC " ph " fax " 0

2 Table of Contents Introduction... 1 Chemistry... 1 Impurities... 1 Use... 1 Cosmetic... 1 Toxicological Studies... 1 Irritation and Sensitization... 1 Data Needs... 2 Tables and Figures... 3 i

3 INTRODUCTION This scientific literature review covers 21 ingredients, that are each mixtures of amino acids, derived from specific plant and animal sources. Accordingly, the group is given the name: source amino acids indicating that they come from specific sources. These ingredients function as skin and hair conditioning agents in personal care products. The full list of ingredients in this report is found in Table 1. Concurrent reviews of the safety of α-amino acids and hydrolyzed proteins from plant and animal sources are being performed by the Cosmetic Ingredient Review (CIR) Expert Panel. CHEMISTRY The ingredients in this group are related because they each are prepared from proteins by complete hydrolysis to yield cosmetic grade amino acid mixtures. The most frequently used method for hydrolyzing proteins to amino acids appears to be heating to at least 110 C with concentrated hydrochloric acid. 1,2 However, some amino acids, including tryptophan, are readily destroyed or are only partially hydrolyzed by hydrochloric acid oxidation, so alternate hydrolysis agents, like sulfonic acid, are used in place of hydrochloric acid, or alkaline hydrolysis is performed. 2-4 It is important to note that although these amino acids are produced from proteins, the hydrolysis process commonly racemizes the amino acids and the end product is not primarily in the L- form of the stereoisomers, but is a mixture of L- and D-. The composition of amino acids may be analyzed by chromatographic separation and detection of the residues, such as liquid-liquid chromatography on ion-exchange columns, after adequate hydrolysis of the substrate. 1,2 Table 2 presents composition data for commercial protein derivative from collagen keratin, silk, and soy hydrolysates. Impurities No data were found in the published literature on the impurities of source amino acids. Unconfirmed composition analyses were found for collagen, keratin, silk, and soy hydrolysate. No composition data were discovered for the remaining source amino acid ingredients. USE Cosmetic The source amino acids in this safety assessment function primarily as hair conditioning and skin conditioning agents in cosmetic formulations. 5 Table 3 presents the current product formulation data for source amino acids. According to information supplied to the Food and Drug Administration (FDA) by industry as part of the Voluntary Cosmetic Registration Program (VCRP), silk amino acids have the most reported uses in cosmetic and personal care products, with a total of 324; approximately half of those uses are in non-coloring hair products. 6 Wheat amino acids have the second greatest number of overall uses reported, with a total of 257; again, approximately half of those uses are in noncoloring hair products. At this time, the Personal Care Products Council is performing a use concentration survey and CIR is awaiting those results. The European Commission s Scientific Committee on Consumer Products (SCCP) concluded that the risk of exposure to viruses, such as avian influenza virus or papillomavirus, is negligible through topical application of cosmetic products containing amino acids from the hydrolysis of human hair or chicken feathers. 7 TOXICOLOGICAL STUDIES Many of the source amino acids in this assessment are found in the foods we consume daily, and the daily exposure from food use would result in a much larger systemic dose than that resulting from use in cosmetic products. These ingredients would be safe if absorbed into the body. Consequently, single dose toxicity, repeated dose toxicity, or other systemic toxicity studies are not addressed in this report. The safety focus of use of these amino acids as cosmetic ingredients is on the potential for irritation and sensitization. IRRITATION AND SENSITIZATION No data were found in the published literature on irritation or sensitization through dermal application of source amino acids. 1

4 DATA NEEDS The data needs in order to prepare a safety assessment of source amino acids includes: method of manufacturing, impurities and approximate composition for cosmetic grade ingredients, physical properties, and dermal irritation and sensitization data. Data will be obtained from an industry survey of current uses and use concentrations as a function of cosmetic product type. 2

5 TABLES AND FIGURES Table 1. Definitions and functions of the ingredients in this safety assessment. 5 (The italicized text below represents additions made by CIR staff.) Ingredient CAS No. Definition Function Apricot Kernel Amino Acids [generic to any amino acids mixture] Collagen Amino Acids Corn Gluten Amino Acids Elastin Amino Acids Garcinia Mangostana Amino Acids Keratin Amino Acids Jojoba Amino Acids Keratin Amino Acids Lupine Amino Acids Lycium Barbarum Amino Acids Milk Amino Acids Oat Amino Acids Apricot Kernel Amino Acids is a mixture of amino acids derived from the complete hydrolysis of apricot kernels. Collagen Amino Acids is the mixture of amino acids resulting from the complete hydrolysis of collagen. It is characterized by containing a significant level of hydroxyproline. Corn Gluten Amino Acids is the mixture of amino acids resulting from the complete hydrolysis of corn gluten protein. Elastin Amino Acids is the mixture of amino acids resulting from the complete hydrolysis of elastin. Garcinia Mangostana Amino Acids are the amino acids obtained by the complete hydrolysis of the protein from the pericarp of Garcinia mangostana. Keratin Amino Acids are the keratin amino acids obtained by the hydrolysis of human hair. Jojoba Amino Acids is the mixture of amino acids obtained by the complete hydrolysis of jojoba seed protein. Keratin Amino Acids is the mixture of amino acids resulting from the complete hydrolysis of Keratin. Lupine Amino Acids is a mixture of amino acids derived from the complete hydrolysis of lupine protein. Lycium Barbarum Amino Acids is a mixture of amino acids derived by the complete hydrolysis of the protein isolated from the whole plant, Lycium barbarum. Milk Amino Acids is the mixture of amino acids resulting from the complete hydrolysis of Milk Protein. Oat Amino Acids is a mixture of amino acids derived by the complete hydrolysis of oat protein. s; Emollient 3

6 Table 1. Definitions and functions of the ingredients in this safety assessment. 5 (The italicized text below represents additions made by CIR staff.) Ingredient CAS No. Definition Function Rice Amino Acids Sesame Amino Acids Silk Amino Acids Soy Amino Acids Spirulina Amino Acids Sweet Almond Amino Acids Vegetable Amino Acids Wheat Amino Acids Yeast Amino Acids Rice Amino Acids is the mixture of amino acids derived from the complete hydrolysis of rice protein. Sesame Amino Acids are the amino acids obtained from the complete hydrolysis of sesame flour. Silk Amino Acids is the mixture of amino acids resulting from the complete hydrolysis of silk. Soy Amino Acids is a mixture of amino acids derived from the complete hydrolysis of soy protein. Spirulina Amino Acids is the mixture of amino acids derived from the complete hydrolysis of the protein obtained from the aquatic plant, Spirulina platensis. Sweet Almond Amino Acids is a mixture of amino acids derived from the complete hydrolysis of Prunus Amygdalus Dulcis (Sweet Almond) Protein. Vegetable Amino Acids are the amino acids obtained by the complete hydrolysis of Hydrolyzed Vegetable Protein Wheat Amino Acids is a mixture of amino acids resulting from the complete hydrolysis of wheat protein. Yeast Amino Acids are the amino acids derived from Yeast. Skin Protectants; 4

7 Table 2. Composition of commercialized protein derivatives. 1,8 Collagen hydrolysate (g/100 g protein) Keratin hydrolysate (g/100 g protein) Silk hydrolysate (g/100 g protein) Isolated soy protein (g/16 g nitrogen) Cysteic acid Hydroxyproline NR Aspartic acid Threonine Serine Glutamic acid Proline Glycine Alanine Cystine Valine Methionine Isoleucine Leucine Tyrosine Phenylalanine Lysine Histidine Arginine Tryptophan NR NR NR Lysinoalanine NR NR NR NR=Not reported. 5

8 Table 3a. Frequency and concentration of use according to duration and type of exposure. 6 # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Collagen Amino Acids Keratin Amino Acids Keratin Amino Acids Totals* 37 NR 33 NR 158 NR Duration of Use Leave-On 27 NR 13 NR 74 NR Rinse-Off 10 NR 20 NR 84 NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 1 NR NR NR 2 NR Incidental Ingestion NR NR NR NR NR NR Incidental Inhalation-Spray NR NR NR NR 4 NR Incidental Inhalation-Powder NR NR NR NR NR NR Dermal Contact 21 NR 1 NR 9 NR Deodorant (underarm) NR NR NR NR NR NR - Non-Coloring 10 NR 31 NR 117 NR -Coloring NR NR 1 NR 21 NR Nail 6 NR NR NR 9 NR Mucous Membrane 1 NR 1 NR NR NR Baby Products NR NR NR NR NR NR Lupine Amino Acids Milk Amino Acids Oat Amino Acids Totals* 6 NR 18 NR 7 NR Duration of Use Leave-On 2 NR 1 NR 4 NR Rinse Off 4 NR 17 NR 3 NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area NR NR NR NR NR NR Incidental Ingestion NR NR NR NR NR NR Incidental Inhalation-Spray NR NR NR NR NR NR Incidental Inhalation-Powder NR NR NR NR NR NR Dermal Contact NR NR 17 NR 1 NR Deodorant (underarm) NR NR NR NR NR NR - Non-Coloring 6 NR 1 NR 6 NR -Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane NR NR 16 NR NR NR Baby Products NR NR NR NR NR NR Rice Amino Acids Silk Amino Acids Soy Amino Acids Totals* 1 NR 324 NR 20 NR Duration of Use Leave-On 1 NR 151 NR 11 NR Rinse-Off NR NR 173 NR 9 NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 1 NR 6 NR NR NR Incidental Ingestion NR NR NR NR NR NR Incidental Inhalation-Spray NR NR 17 NR NR NR Incidental Inhalation-Powder NR NR NR NR NR NR Dermal Contact NR NR 50 NR 3 NR Deodorant (underarm) NR NR NR NR NR NR - Non-Coloring NR NR 265 NR 16 NR -Coloring NR NR 2 NR NR NR Nail NR NR 4 NR 1 NR Mucous Membrane NR NR 21 NR NR NR Baby Products NR NR NR NR NR NR 6

9 Table 3a. Frequency and concentration of use according to duration and type of exposure. 6 # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Vegetable Amino Acids Wheat Amino Acids Totals 1 NR 257 NR Duration of Use Leave-On NR NR 89 NR Rinse Off 1 NR 168 NR Diluted for (Bath) Use NR NR NR NR Exposure Type Eye Area NR NR 1 NR Incidental Ingestion NR NR NR NR Incidental Inhalation-Spray NR NR 6 NR Incidental Inhalation-Aerosol NR NR NR NR Dermal Contact NR NR 11 NR Deodorant (underarm) NR NR NR NR - Non-Coloring 1 NR 193 NR -Coloring NR NR 51 NR Nail NR NR 1 NR Mucous Membrane NR NR 5 NR Baby Products NR NR 1 NR * Because each ingredient may be used in cosmetics with multiple exposure types, the sum of all exposure types my not equal the sum of total uses. NR no reported uses Table 3b. Ingredients not reported to be in use. Apricot Kernel Amino Acids Corn Gluten Amino Acids Elastin Amino Acids Garcinia Mangostana Amino Acids Jojoba Amino Acids Keratin Amino Acids Lycium Barbarum Amino Acids Sesame Amino Acids Spirulina Amino Acids Sweet Almond Amino Acids Yeast Amino Acids 7

10 REFERENCES 1. Arnaud JC and Bore P. Ion-exchange chromatography for the analysis of protein derivatives and specific amino acids.? 1980; Fountoulakis M and Lahm H-W. Hydrolysis and amino acid composition analysis of proteins. J Chromatogr A. 1998;826: Simpson RJ, Neuberger MR, and Liu T-Y. Complete amino acid analysis of proteins from a single hydrolysate. J Bio Chem. 1976;251(7): Fujiya NM and Tavares MFM. Analysis of underivatized amino acids in protein hydrolysates for cosmetic application by capillary electrophoresis. J Sep Sci. 2003;26: Gottschalck TE and Breslawec HP. International Cosmetic Ingredient Dictionary and Handbook. 14 ed. Washington, DC: Personal Care Products Council, Food and Drug Administration (FDA). Frequency of use of cosmetic ingredients. FDA Database Washington, DC: FDA. 7. Scientific Committee on Consumer Products (SCCP). Opinion on Amino Acids Obtained by Hydrolysis of Human. European Commission Health & Consumer Protection Directorate-General Report No. SCCP/0894/ De Groot AP and Slump P. Effects of severe alkali treatment of proteins on amino acid composition and nutritive value. J Nutr. 1969;98: