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GREEN BOOK 2 & GREEN BOOK 3 Vegetable Oils Nut Oils CIR

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GREEN BOOK 2 & GREEN BOOK 3 Vegetable Oils Nut Oils CIR GREEN BOOK 2 & GREEN BOOK 3 Vegetable Oils Nut Oils CIR EXPERT PANEL MEETING AUGUST 30-31, 2010 GREEN BOOK 2 Oils CIR EXPERT PANEL MEETING AUGUST 30-31, 2010 CIR Panel Book Page 1 Memorandum To: CIR Expert Panel Members and Liaisons From: Christina L. Burnett, Scientific Writer/Analyst Date: July 30, 2010 Subject: Draft Report of the Vegetable Oil Group The Scientific Literature Review (SLR) for this group of edible vegetable (and fruit) oils was announced April 23, 2010. A related SLR on edible nut oils was announced in June of this year, and is to be reviewed by the Panel at this meeting as well. If the Panel does not see any major differences in the overall toxicity potential of these two oil groups, it may consider combining the reports into one major edible oil report. Both reports are taking a slightly new approach to reviewing multiple related ingredients at one time and are including oil ingredients that have previously been reviewed by the CIR Expert Panel, which are designated in italic print. At the time that the SLR was announced, CIR sought the following additional information: 1. Manufacturing information about oils used in cosmetic formulation, particularly on methods used to remove non-fatty acid components (e.g., glycidol fatty acid esters); 2. Cosmetic grade specifications, if such exist, for oils used in cosmetic formulations. 3. Fatty acid composition for those oils covered in this report (where such information has not been provided or differs from what is presented). 4. Irritation and sensitization testing on cosmetics (finished products) containing specified concentrations of oils covered in this report. 5. Irritation and sensitization testing on those fatty acids present in the oils covered in this report that have previously not been reviewed by CIR. 6. Any other information that pertains to the safety of the use in cosmetics of the oils covered in this report. Data on fatty acid compositions and cosmetic grade specifications, as well as an HRIPT studies on numerous oils have been received from the Personal Care Products Council and are incorporated in this draft report in Tables 3, 4, and 7, respectively. Due to the voluminous amount of unpublished data (800+ pages), data will be accessible online. Paper copies will be mailed out only by request. Please note that the new use table is being employed in this report. The raw data from which the table was created along with any available concentration of use information have been included in the book materials. If the data provided are sufficient for the Panel to assess the safety of these ingredients, a tentative conclusion should be developed regarding their safety in cosmetics, along with a rationale for that conclusion. The report will then be issued as a Tentative Safety Assessment. If additional data are needed, these should be identified and an Insufficient Data Announcement should be issued. For your convenience, the materials for this report can also be found at http://www.cir-safety.org/aug10.shtml. CIR Panel Book Page 2 CIR Panel Book Page 3 CIR Expert Panel History with Vegetable Oils April 2010 - CIR issued a Scientific Literature Review. CIR Panel Book Page 4 Literature Search on Vegetable Oils Ingredients Toxline ChemIDplus HSDB CAplus NTIS HPV Merck USP PubMed √ √ √ √ √ √ √ Ingredients were searched by Latin botanical (INCI) names, common names, and CAS numbers, when available. The list of ingredients searched is found in Table 1 of the vegetable oil report. Literature searches included chemical composition, fatty acid composition, dermal toxicity, irritation, and sensitization qualifiers. Searches were performed between November 20, 2009 and March 30, 2010 and updated June 30 through July 8, 2010. 1 CIR Panel Book Page 5 Report CIR Panel Book Page 6 Draft Report Vegetable Oil, Related Plant-Derived Oils, and Other Derivatives as Used in Cosmetics August 30, 2010 The 2010 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 F. Alan Andersen, Ph.D. This report was prepared by Christina L. Burnett and Monice Fiume, Scientific Analyst/Writers. © Cosmetic Ingredient Review 1101 17th Street, NW, Suite 412 " Washington, DC 20036-4702 " ph 202.331.0651 " fax 202.331.0088 " [email protected] CIR Panel Book Page 7 TABLE OF CONTENTS INTRODUCTION ................................................................................................................................................................. 1 Chemistry ............................................................................................................................................................................... 1 Processing ...................................................................................................................................................................... 2 Analytical Methods ............................................................................................................................................................ 2 Impurities ....................................................................................................................................................................... 2 Use ......................................................................................................................................................................................... 3 Cosmetic ............................................................................................................................................................................ 3 Non-Cosmetic .................................................................................................................................................................... 4 ANIMAL TOXICOLOGY .................................................................................................................................................... 4 OILS .............................................................................................................................................................................. 4 Dermal Irritation/Sensitization/Phototoxicity .................................................................................................................... 4 Adansonia Digitata Seed Oil [Baobab] .......................................................................................................................... 4 Carthamus Tinctorius (Safflower) Oil ........................................................................................................................... 4 Gossypium Herbaceum (Cotton) Seed Oil..................................................................................................................... 4 Elaeis Guineensis (Palm) Oil ......................................................................................................................................... 5 Olea Europea (Olive) Fruit Oil ...................................................................................................................................... 5 Oryza Sativa (Rice) Bran Oil and Germ Oil .................................................................................................................. 5 Sesamum Indicum (Sesame) Seed Oil ........................................................................................................................... 5 Triticum Vulgare (Wheat) Germ Oil ............................................................................................................................. 6 Zea Mays (Corn) Oil ...................................................................................................................................................... 6 Ocular Irritation ................................................................................................................................................................. 6 Adansonia Digitata Seed Oil [Baobab] .......................................................................................................................... 6 Elaeis Guineensis (Palm) Oil ......................................................................................................................................... 6 Gossypium Herbaceum (Cotton) Seed Oil..................................................................................................................... 6 Linum Usitatissimum (Linseed) Seed Oil ...................................................................................................................... 6 Olea Europea (Olive) Fruit Oil ...................................................................................................................................... 7 Oryza Sativa (Rice) Bran and Rice Germ Oil ................................................................................................................ 7 Ribes Nigrum (Black Currant) Seed Oil ........................................................................................................................ 7 Sesamum Indicum (Sesame) Seed Oil ........................................................................................................................... 7 Triticum Vulgare (Wheat) Germ Oil ............................................................................................................................
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