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Safety Assessment of Inorganic Sulfates As Used in Cosmetics

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Safety Assessment of Inorganic Sulfates As Used in Cosmetics Safety Assessment of Inorganic Sulfates as Used in Cosmetics Status: Draft Report for Panel Review Release Date: February 21, 2014 Panel Date: March 17-18, 2014 The 2014 Cosmetic Ingredient Review Expert Panel members are: Chair, 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 Lillian J. Gill, D.P.A. This report was prepared by Wilbur Johnson, Jr., M.S., Senior Scientific Analyst and Bart Heldreth, Ph.D., Chemist. © Cosmetic Ingredient Review 1620 L STREET, N.W., SUITE 1200 ◊ WASHINGTON, DC 20036-4702 ◊ PH 202.331.0651 ◊ FAX 202.331.0088 ◊ [email protected] Commitment & Credibility since 1976 Memorandum To: CIR Expert Panel Members and Liaisons From: Wilbur Johnson, Jr. Senior Scientific Analyst Date: February 21, 2014 Subject: Draft Report on Inorganic Sulfates A Scientific Literature Review (SLR) on inorganic sulfates was issued on December 2, 2013. Use concentration data received from the Personal Care Products Council (Council) were incorporated prior to announcement of the SLR. Comments from the Council were received during the 60-day comment period. Included in this package for your review is the Draft Report on Inorganic Sulfates, the CIR report history, Literature search strategy, Ingredient Data profile, 2013 FDA VCRP data, use concentration data from the Council (data1 pdf file), final reports on sodium sulfate and ammonium, potassium, and sodium persulfates (final1 and final2 pdf files), and comments provided by the Council (pcpc1 and pcpc2 pdf files). These comments will be addressed prior to the March 2014 Panel meeting. It should be noted that the Expert Panel previously issued final reports on the safety of the following inorganic sulfates in cosmetics: sodium sulfate (published in 2000) and ammonium persulfate, potassium persulfate, and sodium persulfate (published in 2001). The Panel concluded that sodium sulfate is safe as used in rinse-off formulations and safe up to 1% in leave-on formulations. Additionally, the Panel concluded that the 3 persulfates are safe as used as oxidizing agents in hair colorants and lighteners designed for brief discontinuous use followed by thorough rinsing from the hair and skin. Concern over sensitization and urticaria potential was the basis for the Panel’s conclusion on persulfates, and the Panel’s conclusion on sodium sulfate was based on concern over skin irritation potential. The current safety assessment has been revised to include new sensitization data on ammonium, potassium, and sodium persulfates from the published literature, in light of the limited sensitization data (on copper sulfate) that were identified initially. With this in mind, the Panel needs to determine whether these sensitization data, which justify the Panel’s earlier conclusion on persulfates, can be used to evaluate the sensitization potential of all of the inorganic sulfates reviewed in this safety assessment. Additionally, after reviewing the available data, the Panel needs to determine whether an insufficient data announcement or tentative report with a safe as used, safe with qualifications, or unsafe conclusion should be issued. __________________________________________________________________________________________ 1620 L Street, 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 Distributed for Comment Only -- Do Not Cite or Quote CIR History of: Inorganic Sulfates A Scientific Literature Review (SLR) was announced on December 2, 2013. Use concentration data received from the Personal Care Products Council (Council) were incorporated prior to announcement of the SLR. Comments from the Council were received during the 60-day comment period. Draft Report, Belsito and Marks Teams/Panel: March 17-18, 2013 The draft has been revised to include sensitization data on ammonium, potassium, and sodium persulfate, which may be useful in evaluating the sensitization potential of all of the inorganic sulfates reviewed in this safety assessment. Distributed for Comment Only -- Do Not Cite or Quote Inorganic Sulfates Check List for March, 2014. Analyst – Wilbur Johnson Repeated dose Acute toxicity Irritation Sensitization toxicity Penetration Skin Enhancement Penetration ADME Oral Parenteral Dermal Inhale O Irritation Ocular Animal Dermal Irr. Human Dermal Irr Animal Sensitization Human Sensitization toxicity Repro/Devel Genotoxicity ty Carcinogenici Phototoxicity Parenteral Dermal Inhale ral Aluminum Sulfate X X X X X X X X X Ammonium Persulfate X X X Ammonium Sulfate X X X X X X Barium Sulfate X X X X X X Calcium Sulfate X X X Calcium Sulfate X X X Hydrate Copper Sulfate X X X X X X X X X X X X X X X Ferric Sulfate X X Ferrous Ammonium X X X X Sulfate Ferrous Sulfate X X X X X X X X Hydroxylamine Sulfate X X X X X X X Magnesium Sulfate X X X X X X X X Manganese Sulfate X X X X X X X X Potassium Persulfate X Potassium Sulfate Silver Sulfate X Sodium Bisulfate X X Sodium Persulfate Sodium Sulfate X Zinc Sulfate X X X X X X X X X X X Distributed for Comment Only -- Do Not Cite or Quote Literature Searches on Inorganic Sulfates (1/2013 and 9/2013) SciFinder Searches Search Terms Aluminum Sulfate Ammonium Persulfate* Ammonium Sulfate Barium Sulfate Calcium Sulfate Calcium Sulfate Hydrate Copper Sulfate Ferric Sulfate Ferrous Ammonium Sulfate Ferrous Sulfate Hydroxylamine Sulfate Magnesium Sulfate Manganese Sulfate Potassium Persulfate* Potassium Sulfate Silver Sulfate Sodium Bisulfate Sodium Persulfate* Sodium Sulfate Zinc Sulfate *Searches performed on 12/11/2013 Distributed for Comment Only -- Do Not Cite or Quote Safety Assessment of Inorganic Sulfates as Used in Cosmetics Status: Draft Report for Panel Review Release Date: February 21, 2014 Panel Date: March 17-18, 2014 The 2014 Cosmetic Ingredient Review Expert Panel members are: Chair, 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 Lillian J. Gill, D.P.A. This report was prepared by Wilbur Johnson, Jr., M.S., Senior Scientific Analyst and Bart Heldreth, Ph.D., Chemist. © Cosmetic Ingredient Review 1620 L STREET, N.W., 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 Table of Contents INTRODUCTION .............................................................................................................................................................. 1 CHEMISTRY ..................................................................................................................................................................... 1 PHYSICAL AND CHEMICAL PROPERTIES ................................................................................................................................... 1 METHOD OF MANUFACTURE.................................................................................................................................................... 1 COMPOSITION/IMPURITIES ....................................................................................................................................................... 2 USE ..................................................................................................................................................................................... 2 COSMETIC ................................................................................................................................................................................ 2 NON-COSMETIC ....................................................................................................................................................................... 3 TOXICOKINETICS .......................................................................................................................................................... 3 TOXICOLOGY .................................................................................................................................................................. 7 ACUTE TOXICITY ..................................................................................................................................................................... 7 Inhalation ........................................................................................................................................................................... 7 Oral .................................................................................................................................................................................... 8 Dermal ............................................................................................................................................................................. 10 Intraperitoneal ................................................................................................................................................................. 10 Intravenous ......................................................................................................................................................................
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