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Safety Assessment of Phosphoric Acid and Its Simple Salts As Used in Cosmetics

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Safety Assessment of Phosphoric Acid and Its Simple Salts As Used in Cosmetics Safety Assessment of Phosphoric Acid and Its Simple Salts as Used in Cosmetics Status: Draft Final Report for Panel Review Release Date: September 2, 2016 Panel Date: September 26-27, 2016 The 2016 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 Director is Lillian J. Gill, D.P.A. This report was prepared by Wilbur Johnson, Jr., M.S., Senior Scientific Analyst, Ivan Boyer, Ph.D., Toxicologist, and Bart Heldreth, Ph.D., Chemist. © 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◊ WASHINGTON, DC 20036-4702 ◊ PH 202.331.0651 ◊ FAX 202.331.0088 ◊ [email protected] Distributed for Comment Only -- Do Not Cite or Quote Commitment & Credibility since 1976 Memorandum To: CIR Expert Panel Members and Liaisons From: Wilbur Johnson, Jr. Senior Scientific Analyst Date: September 2, 2016 Subject: Draft Final Report on Phosphoric Acid and Its Simple Salts At the March 31-April 1, 2016 CIR Expert Panel Meeting, the Panel concluded that the 31 ingredients reviewed in this safety assessment are safe in the present practices of use and concentration in cosmetics, as described in this safety assessment, when formulated to be non-irritating. A tentative report with this conclusion was issued on April 12, 2016. Included in this package for your review is the Draft Final Report (phoslt092016rep), the CIR report history (phoslt092016hist), literature search strategy (phoslt092016strat), ingredient data profile (phoslt092016prof), minutes from the March 31-April 1, 2016 Panel meeting (phoslt092016min), 2016 FDA VCRP data (phoslt092016FDA), and comments received from the Council (phoslt092016pcpc). Council comments have been addressed. After considering the data included in this safety assessment, the Panel will need to determine whether a Final Report with the conclusion stated above should be issued. __________________________________________________________________________________________ 1620 L Street, N.W., Suite1200, 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 __Phosphoric Acid and Simple Salts _____________________________________ MEETING _____Sept 2016_________________________________________________________________________________________ Public Comment CIR Expert Panel Report Status Priority List INGREDIENT PRIORITY LIST SLR Nov 20, 2015 DRAFT REPORT Mar 2016 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 April 12, 2016 DRAFT FINAL REPORT Draft FR Sept 2016 60 day Public comment period Table Table Different Conclusion Issue PUBLISH Final Report FR Distributed for Comment Only -- Do Not Cite or Quote CIR History of: Phosphoric Acid and Simple Salts A scientific literature review (SLR) on Phosphoric Acid and Simple Salts was issued on November 17, 2015 Unpublished data were received during the 60-day comment period. Draft Report, Belsito and Marks Teams/Panel: March 31-April 1, 2016 Use concentration data and comments received from the Council during the 60-day comment period have been added. The CIR Expert Panel concluded that the 31 ingredients reviewed in this safety assessment are safe in the present practices of use and concentration in cosmetics as described in this safety assessment, when formulated to be non- irritating. A tentative report with this conclusion was issued. Draft Final Report, Belsito and Marks Teams/Panel: September 26-27, 2016 Comments received from the Council have been addressed. Distributed for Comment Only -- Do Not Cite or Quote Phosphoric Acid And Simple Salts Check List for September 2016. 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 Phosphoric Acid X X X X X X X X X X X Ammonium Phosphate X X Dicalcium Phosphate X X X X Calcium Dihydrogen X X Phosphate Calcium Phosphate X X X X Calcium Potassium Sodium Phosphate Calcium X X Pyrophosphate Diammonium X X X X Phosphate Dicalcium Phosphate X Dihydrate Dipotassium X X X X X Phosphate Disodium Phosphate X X X X Disodium X X X X Pyrophosphate Magnesium Hydrogen Phosphate Magnesium Phosphate X X Metaphosphoric Acid X Pentapotassium X X Triphosphate Pentasodium X X X X X Triphosphate Phosphate Buffered Saline Potassium X X Metaphosphate Potassium Phosphate X X X Potassium Polyphosphate Sodium X X X X X X Hexametaphosphate Distributed for Comment Only -- Do Not Cite or Quote Phosphoric Acid And Simple Salts Check List for September 2016. 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 Sodium X X X X Metaphosphate Sodium X X X X X Polyphosphate Sodium Phosphate X X X X X X Sodium X X X X Trimetaphosphate Tetrapotassium X X X Pyrophosphate Tetrasodium X X X X X Pyrophosphate X X X X X Tricalcium Phosphate X X Trimagnesium Phosphate Trisodium Phosphate X X Distributed for Comment Only -- Do Not Cite or Quote [Phosphoric Acid and its Simple Salts] Ingredient CAS # InfoBase SciFinder PubMed TOXNET FDA EU ECHA IUCLID SIDS HPVIS NICNAS NTIS NTP WHO FAO FEMA Web Phosphoric Acid 7664-38-2 1/1 1853/118 7057/68 Yes No Yes Yes Yes Yes Yes Yes Yes No Yes Yes Metaphosphoric Acid 10343-62-1 1/1 16123/15 143/4 No No Yes No No No Yes Yes No No Yes No Ammonium Phosphate 7722-76-1 1/1 22673/54 890/13 Yes No Yes No Yes Yes Yes Yes No No Yes No Diammonium Phosphate 7783-28-0 1/1 18942/47 92/5 No No Yes No Yes Yes Yes Yes No No No No Disodium Phosphate 10140-65-5 1/1 18/1 232/5 Yes No Yes No No Yes No Yes No No No No Disodium Pyrophosphate 7758-16-9 1/1 1524/42 0/0 No No Yes Yes Yes Yes Yes Yes No No Yes No Pentasodium Triphosphate 7758-29-4 1/1 16142/64 17/0 No No Yes No Yes Yes Yes Yes No No Yes No Sodium Hexametaphosphate 10124-56-8 1/1 1898/26 0/0 Yes No Yes No Yes Yes Yes Yes No No No Yes Sodium Metaphosphate 10361-03-2 1/1 2348/14 52/1 Yes No Yes No Yes No Yes Yes No No Yes No Sodium Polyphosphate 68915-31-1 1/1 1715/32 1250/16 No No Yes Yes Yes Yes Yes Yes No No No No Sodium Phosphate 7558-80-7 1/1 19165/30 5367/35 Yes No Yes Yes Yes Yes Yes Yes No No Yes No Sodium Trimetaphosphate 7785-84-4 1/1 1901/46 125/2 Yes No Yes No Yes Yes Yes Yes No No No No Tetrasodium Pyrophosphate 7722-88-5 1/1 10989/15 0/0 No No Yes No Yes Yes Yes Yes No No Yes No Trisodium Phosphate 7601-54-9 1/1 16460/49 171/17 No No Yes No Yes Yes Yes Yes Yes No Yes No Dipotassium Phosphate 7758-11-4 1/1 18195/8 633/56 Yes No Yes Yes Yes Yes Yes Yes No No Yes No Pentapotassium Triphosphate 13845-36-8 1/1 1059/29 754/14 No No Yes No Yes Yes Yes Yes No No Yes No Potassium Metaphosphate 7790-53-6 1/1 1260/15 7/3 No No Yes No No Yes Yes Yes No No Yes No Potassium Phosphate 16068-46-5 1/1 4715/155 2269/20 Yes No Yes Yes No No Yes Yes No No No No Potassium Polyphosphate 68956-75-2 1/1 270/3 117/10 No No Yes No No Yes Yes Yes No No No No Tetrapotassium Pyrophosphate 7320-34-5 1/1 3670/8 17/5 No No Yes No Yes Yes Yes Yes No No Yes No Calcium Dihydrogen Phosphate 7758-23-8 1/1 11054/31 12/0 No No Yes Yes Yes Yes Yes Yes No No No No Calcium Phosphate 10103-46-5 1/1 957/25 13279/135 Yes Yes Yes Yes Yes Yes Yes Yes No No No No Calcium Pyrophosphate 7790-76-3 1/1 1641/20 1588/23 Yes No Yes Yes No No Yes Yes No Yes Yes No Dicalcium Phosphate 7757-93-9 1/1 19392/232 725/133 No No Yes Yes Yes Yes Yes Yes No No Yes No Dicalcium Phosphate Dihydrate 7789-77-7 1/1 3270/41 315/57 No No Yes Yes Yes No Yes Yes No No No No Tricalcium Phosphate 7758-87-4 1/1 20604/273 3888/30 No No Yes No Yes Yes Yes Yes No No No Yes Magnesium Hydrogen Phosphate 7782-75-4 1/1 211/2 12/0 No No Yes Yes No No Yes Yes No No No No Magnesium Phosphate 10043-83-1 1/1 2328/21 308/40 Yes No Yes No Yes No Yes Yes No Yes No No Distributed for Comment Only -- Do Not Cite or Quote Ingredient CAS # InfoBase SciFinder PubMed TOXNET FDA EU ECHA IUCLID SIDS HPVIS NICNAS NTIS NTP WHO FAO FEMA Web Trimagnesium Phosphate 7757-87-1 1/1 1371/22 7/3 No No Yes No Yes No Yes Yes No Yes Yes No Calcium Potassium Sodium 131862-42-5 1/1 68/2 92/11 No No No No No No No No No No No No Phosphate Phosphate Buffered Saline 1/1 29911/10 11314/113 No No No No No Yes Yes Yes No No No No Search Strategy [document search strategy used for SciFinder, PubMed, and Toxnet] [identify total # of hits / # hits that were useful/examined for usefulness] Distributed for Comment Only -- Do Not Cite or Quote LINKS InfoBase (self-reminder that this info has been accessed; not a public website) - http://www.personalcarecouncil.org/science-safety/line-infobase ScfFinder (usually a combined search for all ingredients in report; list # of this/# useful) - https://scifinder.cas.org/scifinder PubMed (usually a combined search for all ingredients in report; list
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