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Safety Assessment of Citrus-Derived Ingredients As Used in Cosmetics

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Safety Assessment of Citrus-Derived Ingredients As Used in Cosmetics Safety Assessment of Citrus-Derived Ingredients as Used in Cosmetics Status: Scientific Literature Review for Public Comment Release Date: December 3, 2013 Panel Meeting Date: March 17-18, 2014 All interested persons are provided 60 days from the above release date to comment on this safety assessment and to identify additional published data that should be included or provide unpublished data which can be made public and included.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 All unpublished data submitted to CIR will be discussed in open meetings, will be available at the CIR office for review by any interested party and may be cited in a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 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.; 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 Christina Burnett, Scientific Analyst/Writer and Monice Fiume, Senior 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] TABLE OF CONTENTS Introduction ...................................................................................................................................................................................................... 1 Chemistry ......................................................................................................................................................................................................... 1 Physical and Chemical Properties ................................................................................................................................................................ 1 Method of Manufacturing ............................................................................................................................................................................ 1 Constituents/Composition ............................................................................................................................................................................ 2 Use .................................................................................................................................................................................................................... 2 Cosmetic ...................................................................................................................................................................................................... 2 Non-Cosmetic .............................................................................................................................................................................................. 3 Toxicokinetics .................................................................................................................................................................................................. 4 Toxicological Studies ....................................................................................................................................................................................... 4 Acute Toxicity ............................................................................................................................................................................................. 4 Dermal – Non-Human............................................................................................................................................................................. 4 Repeated Dose Toxicity ............................................................................................................................................................................... 4 Reproductive and Developmental Toxicity ...................................................................................................................................................... 4 Genotoxicity ..................................................................................................................................................................................................... 4 Carcinogenicity ................................................................................................................................................................................................. 4 Irritation and Sensitization ................................................................................................................................................................................ 5 Dermal Irritation .......................................................................................................................................................................................... 5 Ocular Irritation ........................................................................................................................................................................................... 5 Sensitization ................................................................................................................................................................................................. 5 Phototoxicity and Photosensitization ........................................................................................................................................................... 5 Case Studies ................................................................................................................................................................................................. 5 Occupational Exposure ................................................................................................................................................................................ 6 Summary .......................................................................................................................................................................................................... 6 Figures .............................................................................................................................................................................................................. 8 Tables ............................................................................................................................................................................................................. 10 Table 1. Definitions and functions of Citrus-derived ingredients ........................................................................................................ 10 Table 2. Citrus-ingredients that potentially function solely as fragrance ingredients. ............................................................................... 16 Table 3. Physical and chemical properties of Citrus-derived ingredients................................................................................................... 17 Table 4. Chemical constituents by plant part (amount in ppm) for major Citrus species ................................................................. 20 Table 5. Major constituents in some of the Citrus species ........................................................................................................................ 35 Table 6. Typical levels of 5-methoxypsoralen .......................................................................................................................................... 36 Table 7. Levels of major coumarins and furocoumarins in lemon oil and lime oil .................................................................................... 36 Table 8. Constituents that are established contact allergens in humans, according to the SCCS .............................................................. 36 Table 9. Cosmetic allergens certificate from a manufacturer of orange, lemon, tangerine, and grapefruit fruit waters and bitter orange flower wax ................................................................................................................................................................................................. 37 Table 10. Primary chemical composition of citrus aurantium dulcis (orange) peel wax by percent .......................................................... 38 Table 11. Components of citrus aurantium dulcis (orange) peel wax with color or aroma characteristics ................................................. 38 Table 12. Frequency and concentration of use (2013) according to duration and type of exposure for Citrus-derived ingredients. ......... 39 Table 13. Ingredients that are not reported to be in use............................................................................................................................. 51 Table 14. Dermal irritation studies for Citrus-derived ingredients ............................................................................................................. 52 Table 15. Sensitization studies for Citrus-derived ingredients ................................................................................................................... 53 Table 16.
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