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Safety Assessment of Camellia Sinensis-Derived · PDF fileCamellia sinensis (tea) plant parts. ... The methods below are general processes for food or food ingredients ... Camellia

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    Safety Assessment of

    Camellia Sinensis-Derived Ingredients

    as Used in Cosmetics

    Status: Scientific Literature Review for Public Review

    Release Date: August 14, 2013

    Panel Meeting Date: December 10-11, 2013

    All interested persons are provided 60 days from the above date to comment on this Draft 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    additional published data that should be included or provide unpublished data which can be made public and included.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 All unpublished data submitted to CIR will be discussed in open meetings, will be available at the CIR office for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, Lillian J. Gill D.P.A.

    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]

    Distributed for Comment Only -- Do Not Cite or Quote

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    TABLE OF CONTENTS

    TABLE OF CONTENTS............................................................................................................................................................. ii

    INTRODUCTION ....................................................................................................................................................................... 1

    Chemistry ..................................................................................................................................................................................... 1

    Definition and Description ...................................................................................................................................................... 1

    Physical and Chemical Properties ........................................................................................................................................... 3

    Method of Manufacture ........................................................................................................................................................... 3

    Impurities ................................................................................................................................................................................ 3

    USE .............................................................................................................................................................................................. 4

    Cosmetic .................................................................................................................................................................................. 4

    Non-Cosmetic .......................................................................................................................................................................... 4

    TOXICOKINETICS .................................................................................................................................................................... 4

    Absorption, Distribution, Metabolism, and Excretion ............................................................................................................. 4

    Dermal/Percutaneous .......................................................................................................................................................... 4

    Inhalation ............................................................................................................................................................................ 5

    Antimicrobial Activity ............................................................................................................................................................ 5

    Constituents......................................................................................................................................................................... 5

    Anti-Inflammatory Effects ...................................................................................................................................................... 5

    Cytotoxicity and Cellular Effects ............................................................................................................................................ 5

    TOXICOLOGICAL STUDIES ................................................................................................................................................... 5

    Acute Toxicity ......................................................................................................................................................................... 5

    Dermal Non-Human ......................................................................................................................................................... 5

    Inhalation ............................................................................................................................................................................ 6

    Repeated Dose Toxicity .......................................................................................................................................................... 6

    Inhalation ............................................................................................................................................................................ 6

    REPRODUCTIVE AND DEVELOPMENTAL TOXICITY ...................................................................................................... 6

    Genotoxicity ................................................................................................................................................................................ 6

    In Vitro .................................................................................................................................................................................... 6

    CARCINOGENICITY ................................................................................................................................................................ 6

    Carcinogenicity Reviews ......................................................................................................................................................... 7

    Irritation and sensitization ........................................................................................................................................................... 7

    Irritation ................................................................................................................................................................................... 7

    Dermal Non-Human ......................................................................................................................................................... 7

    Dermal Human ................................................................................................................................................................. 7

    Mucosal ............................................................................................................................................................................... 7

    Ocular .................................................................................................................................................................................. 7

    Sensitization ............................................................................................................................................................................ 8

    Distributed for Comment Only -- Do Not Cite or Quote

  • iii

    Dermal Non-Human ......................................................................................................................................................... 8

    Dermal Human ................................................................................................................................................................. 8

    Phototoxicity ........................................................................................................................................................................... 8

    In Vivo ................................................................................................................................................................................ 8

    In Vitro ................................................................................................................................................................................ 8

    SUMMARY ................................................................................................................................................................................. 9

    DATA NEEDS ............................................................................................................................................................................ 9

    TABLES AND FIGURES ......................................................