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Amended Safety Assessment of Achillea Millefolium-Derived Ingredients As Used in Cosmetics

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Amended Safety Assessment of Achillea Millefolium-Derived Ingredients As Used in Cosmetics Amended Safety Assessment of Achillea Millefolium-Derived Ingredients as Used in Cosmetics Status: Tentative Amended Report for Public Comment Release Date: September 20, 2013 Panel Meeting Date: December 9-10, 2013 All interested persons are provided 60 days from the above date to comment on this Amended Tentative Safety Assessment and to identify additional published data that should be included or provide unpublished data which can be made public and included. Information may be submitted without identifying the source or the trade name of the cosmetic product containing the ingredient. All unpublished data submitted to CIR will be discussed in open meetings, will be available at the CIR office for review by any interested party and may be cited in a peer-reviewed scientific journal. Please submit data, comments, or requests to the CIR Director, Dr. Lillian J. Gill. The 2013 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 Lillian J. Gill, D.P.A. This report was prepared by Lillian C. Becker, Scientific Analyst/Writer. © Cosmetic Ingredient Review 1101 17th Street, NW, Suite 412 Washington, DC 20036-4702 ph 202.331.0651 fax 202.331.0088 [email protected] i TABLE OF CONTENTS TABLE OF CONTENTS............................................................................................................................................................. ii ABSTRACT ................................................................................................................................................................................ 3 INTRODUCTION ....................................................................................................................................................................... 3 Summary of Original Safety Assessment ................................................................................................................................ 3 CHEMISTRY .............................................................................................................................................................................. 3 Definition ................................................................................................................................................................................ 3 Physical and Chemical Properties ........................................................................................................................................... 3 Constituents......................................................................................................................................................................... 4 Constituents of Concern ...................................................................................................................................................... 4 Method of Manufacture ........................................................................................................................................................... 4 USE .............................................................................................................................................................................................. 4 TOXICOKINETICS .................................................................................................................................................................... 4 Absorption, Distribution, Metabolism, and Excretion ............................................................................................................. 4 Cytotoxicity ............................................................................................................................................................................. 5 TOXICOLOGICAL STUDIES ................................................................................................................................................... 5 Acute Toxicity ......................................................................................................................................................................... 5 Oral – Non-Human.............................................................................................................................................................. 5 Intraperitoneal ..................................................................................................................................................................... 5 Repeated Dose Toxicity .......................................................................................................................................................... 5 Oral – Non-Human.............................................................................................................................................................. 5 REPRODUCTIVE AND DEVELOPMENTAL TOXICITY ...................................................................................................... 5 GENOTOXICITY ....................................................................................................................................................................... 6 In Vitro .................................................................................................................................................................................... 6 IRRITATION AND SENSITIZATION ...................................................................................................................................... 6 Irritation ................................................................................................................................................................................... 6 Ocular .................................................................................................................................................................................. 6 Sensitization ............................................................................................................................................................................ 6 Dermal – Non-Human ......................................................................................................................................................... 6 Dermal – Human ................................................................................................................................................................. 6 CLINICAL USE .......................................................................................................................................................................... 7 Case Studies ............................................................................................................................................................................ 7 SUMMARY ................................................................................................................................................................................. 7 DISCUSSION .............................................................................................................................................................................. 7 CONCLUSION............................................................................................................................................................................ 8 TABLES ...................................................................................................................................................................................... 9 REFERENCES .......................................................................................................................................................................... 14 ii ABSTRACT Cosmetic ingredients derived from Achillea millefolium function in cosmetics as skin-conditioning agents – miscellaneous, skin-conditioning agents – humectants; and fragrance ingredients. The CIR Expert Panel reviewed relevant animal and human data to determine their safety in cosmetics. Because formulations may contain more than one botanical ingredient, caution was urged to avoid reaching levels of toxicity for constituents. Industry should use good manufacturing practices to limit impurities. The Panel concluded that achillea millefolium extract, achillea millefolium flower extract, and achillea millefolium flower/leaf/stem extract are safe in the present practices of use and concentration in cosmetics when formulated to be non-sensitizing. INTRODUCTION This is an amended safety assessment of Achillea millefolium (yarrow)-derived ingredients. These ingredients function in cosmetics as skin-conditioning agents – miscellaneous, skin-conditioning agents – humectants; and fragrance ingredients. The three ingredients in this safety assessment are: • achillea millefolium extract • achillea millefolium flower/leaf/stem extract • achillea millefolium flower extract In 2001, the Cosmetic Ingredient Review (CIR) published a safety assessment of achillea millefolium extract as used in cosmetics.1 The CIR Expert Panel (Panel) concluded that there were insufficient data to determine the safety of these ingredients. The data needs were: • UV absorption data; if absorption occurs in the UVA or UVB range, photosensitization data. • Gross pathology and
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