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Safety Assessment of Wheat-Derived Ingredients As Used in Cosmetics

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Safety Assessment of Wheat-Derived Ingredients As Used in Cosmetics Safety Assessment of Wheat-Derived Ingredients as Used in Cosmetics Status: Draft Final Report for Panel Review Release Date: November 13, 2020 Panel Meeting Date: December 7-8, 2020 The Expert Panel for Cosmetic Ingredient Safety members are: Chair, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V. Belsito, M.D.; David E. Cohen, M.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; Lisa A. Peterson, Ph.D.; Ronald C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. Previous Panel member involved in this assessment: James G. Marks, Jr., M.D. The Cosmetic Ingredient Review (CIR) Executive Director is Bart Heldreth, Ph.D. This safety assessment was prepared by Christina L. Burnett, Senior Scientific Analyst/Writer, CIR. © Cosmetic Ingredient Review 1620 L Street, 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♢ Washington, DC 20036-4702 ♢ ph 202.331.0651 ♢ fax 202.331.0088 ♢ [email protected] Distributed for Comment Only -- Do Not Cite or Quote Commitment & Credibility since 1976 Memorandum To: Expert Panel for Cosmetic Ingredient Safety Members and Liaisons From: Christina L. Burnett, Senior Scientific Writer/Analyst , CIR Date: November 13, 2020 Subject: Safety Assessment of Wheat-Derived Ingredients as Used in Cosmetics Enclosed is the Draft Final Report of the Safety Assessment of Wheat-Derived Ingredients as Used in Cosmetics. (It is identified as wheat122020rep in the pdf document.) In June 2020, the Panel reviewed the safety of the 27 ingredients in this report and issued a Tentative Report with the conclusion that the available data are insufficient to make a determination of safety under the intended conditions of use in cosmetic formulations. The Panel’s needs were: • Method of manufacturing data • Dermal irritation and sensitization data at a test concentration of 13% for Triticum Vulgare (Wheat) Sprout Extract Since the June Panel meeting, CIR staff have received method of manufacturing data on Triticum Vulgare (Wheat) Germ Extract (wheat122020data1), and a technical data sheet and a summary of a single insult patch test on a mixture containing approximately 5% Triticum Vulgare (Wheat) Gluten and sodium laureth sulfate (wheat122020data2). These data, and additional information from published literature on wheat allergy, have been incorporated into this draft. These data are highlighted to aid in the Panel’s review. Comments provided by the Council on the Tentative Report have been addressed (wheat122020pcpc). Other supporting documents for this report package include a flow chart (wheat122020flow), the reports previously published by the Panel (wheat122020_flour_orig, wheat122020_gluten_glycerides_orig, wheat122020RR), report history (wheat122020hist), transcripts from the previous meeting (wheat122020min), a search strategy (wheat122020strat), and 2020 VCRP data (wheat122020fda). The Panel should review the Abstract, Discussion, and Conclusion, and 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 _____ Wheat-derived Ingredients ______ MEETING ___December 2020 ______________________________________________________ Public Comment CIR Expert Panel Report Status Priority List INGREDIENT PRIORITY LIST SLR June 20, 2019 DRAFT REPORT Sept 2019 Draft Report 60-day public comment period Table Table IDA TR IDA Notice IDA Sept 20, 2019 DRAFT TENTATIVE REPORT June 2020 Draft TR Table Table Tentative Report Issue TR June 19, 2020 Draft FR DRAFT FINAL REPORT Dec 2020 60-day Public comment period Table Table Different Conclusion Issue PUBLISH Final Report FR Distributed for Comment Only -- Do Not Cite or Quote Wheat-derived ingredients History June 19, 2019 – Scientific Literature Review announced. September 2019 - the Panel issued an Insufficient Data Announcement. The Panel’s needs were: • Method of manufacturing, composition, and impurities data for Triticum Aestivum (Wheat) Germ Extract, Triticum Aestivum (Wheat) Seed Extract, Triticum Monococcum (Wheat) Seed Extract, Triticum Turgidum Durum (Wheat) Seed Extract, Triticum Vulgare (Wheat) Germ Extract, Triticum Vulgare (Wheat) Seed Extract, and Triticum Vulgare (Wheat) Sprout Extract • Dermal irritation and sensitization data at maximum leave-on use concentrations for Triticum Aestivum (Wheat) Germ Extract, Triticum Vulgare (Wheat) Germ Extract, Triticum Vulgare (Wheat) Sprout Extract, and Wheat Germ Glycerides June 2020 – The Panel issued a Tentative Report with the conclusion that the available data are insufficient to make a determination of safety under the intended conditions of use in cosmetic formulations. The Panel’s needs were: • Method of manufacturing data • Dermal irritation and sensitization data at a test concentration of 13% for Triticum Vulgare (Wheat) Sprout Extract Distributed for Comment Only -- Do Not Cite or Quote Wheat-Derived Ingredients, December 2020 – Christina Burnett Toxico- Acute Tox Repeated DART Genotox Carci Dermal Dermal Ocular Clinical kinetics Dose Tox Irr. Sens. Irr. Studies Mfg ro ro n Vit Reported Use GRAS Method of Constituents Impurities Dermal Penetration ADME Dermal Oral Inhalation Dermal Oral Inhalation Dermal Oral I In Vivo Dermal Oral In Vitro Animal Human In Vitro Animal Human Phototoxicity In Vitro Animal Retrospective/ Multicenter Case Reports Triticum Aestivum (Wheat) Flour X Lipids Triticum Vulgare (Wheat) Flour X Lipids Triticum Aestivum (Wheat) Germ X Extract Triticum Vulgare (Wheat) Germ X X X X X X Extract Triticum Aestivum (Wheat) Seed X Extract Triticum Vulgare (Wheat) Seed X Extract Triticum Aestivum (Wheat) Leaf X Extract Triticum Aestivum (Wheat) Peptide Triticum Monococcum (Wheat) Seed X Extract Triticum Monococcum (Wheat) Stem Water Triticum Spelta Seed Water Triticum Turgidum Durum (Wheat) Seed Extract Triticum Vulgare/Aestivum (Wheat) X X Grain Extract Triticum Vulgare (Wheat) Bran X X Triticum Vulgare (Wheat) Bran X X X X Extract Triticum Vulgare (Wheat) Bran Lipids X Triticum Vulgare (Wheat) Flour X X Extract Triticum Vulgare (Wheat) Germ X X X Triticum Vulgare (Wheat) Germ Powder Triticum Vulgare (Wheat) Germ X Protein 1 Distributed for Comment Only -- Do Not Cite or Quote Wheat-Derived Ingredients, December 2020 – Christina Burnett Toxico- Acute Tox Repeated DART Genotox Carci Dermal Dermal Ocular Clinical kinetics Dose Tox Irr. Sens. Irr. Studies Mfg ro ro n Vit Reported Use GRAS Method of Constituents Impurities Dermal Penetration ADME Dermal Oral Inhalation Dermal Oral Inhalation Dermal Oral I In Vivo Dermal Oral In Vitro Animal Human In Vitro Animal Human Phototoxicity In Vitro Animal Retrospective/ Multicenter Case Reports Triticum Vulgare (Wheat) Gluten X X * X X X * * * Triticum Vulgare (Wheat) Gluten X Extract Triticum Vulgare (Wheat) Kernel X X X X Flour Triticum Vulgare (Wheat) Protein X X Triticum Vulgare (Wheat) Sprout X X X X X X Extract Triticum Vulgare (Wheat) Straw Water Wheat Germ Glycerides X * * X * * * * * Generic wheat nomenclature “X” indicates that data were available in a category for the ingredient “*” indicates that data were available in a previous review. 2 Distributed for Comment Only -- Do Not Cite or Quote Wheat-Derived Ingredients Ingredient CAS # InfoB PubMed TOXNET FDA EU ECHA IUCLID SIDS ECETOC HPVIS NICNAS NTIS NTP WHO FAO NIOSH FEMA Web Triticum Vulgare 84012-44-2 √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ (Wheat) Germ Extract Triticum √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ Aestivum (Wheat) Flour Lipids Triticum √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ Aestivum (Wheat) Germ Extract Triticum √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ Aestivum Leaf Extract Triticum √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ Aestivum (Wheat) Peptide Triticum √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ Aestivum (Wheat) Seed Extract Triticum √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ Monococcum (Wheat) Seed Extract Triticum √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ Monococcum (Wheat) Stem Water Triticum √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ Turgidum Durum (Wheat) Seed Extract Triticum √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ Vulgare/Aestivu m (Wheat) Grain Extract Triticum Vulgare √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ (Wheat) Bran Triticum Vulgare 84012-44-2 √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ (Wheat) Bran Extract Triticum Vulgare √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ (Wheat) Flour Extract Distributed for Comment Only -- Do Not Cite or Quote Ingredient CAS # InfoB PubMed TOXNET FDA EU ECHA IUCLID SIDS ECETOC HPVIS NICNAS NTIS NTP WHO FAO NIOSH FEMA Web Triticum Vulgare √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ (Wheat) Flour Lipids Triticum Vulgare √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ (Wheat) Germ Triticum Vulgare √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ (Wheat) Germ Powder Triticum Vulgare √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ (Wheat) Germ Protein Triticum Vulgare √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ (Wheat) Protein Triticum Vulgare 84012-44-2 √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ (Wheat) Seed Extract Triticum Vulgare √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ (Wheat) Sprout Extract Triticum Vulgare √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ (Wheat) Straw Water Triticum Spelta √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ Seed Water Triticum Vulgare √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ (Wheat) Bran Lipids Triticum Vulgare √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ (Wheat) Kernel Flour Triticum 8002-80-0 √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ Vulgare (Wheat) Gluten Triticum √ √ √ √ √ √ √ √ √ √ √ √ √
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