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Safety Assessment of Brown Algae-Derived Ingredients As Used in Cosmetics

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Safety Assessment of Brown Algae-Derived Ingredients As Used in Cosmetics Safety Assessment of Brown Algae-Derived Ingredients as Used in Cosmetics Status: Draft Tentative Report for Panel Review Release Date: November 9, 2018 Panel Meeting Date: December 3-4, 2018 The 2018 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 Executive Director is Bart Heldreth, Ph.D. This report was prepared by Lillian C. Becker, former Scientific Analyst/Writer and Priya Cherian, Scientific Analyst/Writer. © 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1200 ♢ Washington, DC 20036-4702 ♢ ph 202.331.0651 ♢ fax 202.331.0088 [email protected] Distributed for Comment Only -- Do Not Cite or Quote Commitment & Credibility since 1976 Memorandum To: CIR Expert Panel Members and Liaisons From: Priya Cherian, Scientific Writer/Analyst Date: November 9, 2018 Subject: Draft Tentative Report of the Safety Assessment on Brown Algae-Derived Ingredients Enclosed is the Draft Tentative Report of the Safety Assessment of Brown Algae-Derived Ingredients as Used in Cosmetics. (It is identified as broalg122018rep in the pdf document). At the September 2018 meeting, the Panel issued an Insufficient Data Announcement for these 82 ingredients. The Panel’s data needs were: • Composition and organic constituent data for each of these Brown Algae-derived cosmetic ingredients • 28-Day dermal toxicity data for those ingredients that are not GRAS • Sensitization data at relevant use concentrations for all ingredients (e.g., Macrocystis Pyrifera (Kelp) Extract at 36.4%) • Genotoxicity data for those ingredients that are not GRAS Since the September Panel meeting, CIR has received the following data, which have been incorporated into the report and have been designated by highlighting (broalg122018data1 through broalg122018data11). • Manufacturing information, composition data, and an in vivo skin irritation study of several trade name mixtures containing Pelvetia Canaliculata Extract and Laminaria Digitata Extract (broalg122018data1) • An in vivo skin sensitization study of a trade name mixture containing Undaria Pinnatifida Extract in caprylic/capric triglyceride (broalg122018data2) • An in vitro skin irritation study on a trade name mixture containing Undaria Pinnatifida Extract in caprylic/capric triglyceride (broalg122018data3) • Manufacturing information, composition data, a 24 hour patch test, a sensitization study, and an in vitro skin irritation study on several trade name mixtures containing Undaria Pinnatifida Extract (broalg122018data4) • Information received from UNITIS regarding several brown algae ingredients (broalg122018data5) • A dermal irritation study, an in chemico skin sensitization study, an in vitro skin sensitization study, a bacterial reverse mutation study , and an ocular irritation study of a trade name mixture containing Undaria Pinnatifida Cell Culture Extract (0.5-2%) (broalg122018data6) • A dermal irritation test, ocular irritation test, and in vitro sensitization study using a test substance containing 1.3% Sargassum Filipendula Extract (broalg122018data7) • A reverse mutation study, a dermal irritation study, a sensitization study, and an ocular irritation study regarding a trade name mixture containing approximately 4% Macrocystis Pyrifera (Kelp) Extract (broalg122018data8) • A dermal irritation test, ocular irritation test, a genotoxicity study, and composition data of a trade name mixture consisting of Cystoseira Amentacea/Caespitosa/Brachycarpa Extracts (48%) and water (52%) (broalg122018data9) • A dermal irritation test, ocular irritation test, and composition data of a trade name mixture consisting of Himanthalia Elongata Extract (20%), Undaria Pinnatifida Extract (37%) and water (43%) (broalg122018data10) • A genotoxicity test, dermal irritation test, dermal sensitization test, ocular irritation test, and composition data of 48% Halidrys Siliquosa Extract in 52% water. (broalg122018data11) __________________________________________________________________________________________ 1620 L St NW, Suite 1200, 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 The data that were presented to the Panel in Wave 2 and Wave 3 for the September meeting have also been incorporated into the report. (These data are not highlighted.) Comments provided by the Council prior to the September meeting on the draft report have been addressed (broalg122018pcpc). In addition, the flow chart (broalg122018flow), updated data profile (broalg122018prof), VCRP data (broalg122018FDA), minutes (broalg122018min), history (broalg122018hist), and search strategy (broalg122018strat), have been included in this packet. A draft Discussion has been incorporated into the report, based on the proceedings and comments from the September meeting. The Discussion draft addresses irritation/sensitization data, impurities concerns, estrogenic effects, and the outstanding data needs. Please determine if these concerns are addressed properly, and identify any other issues that need to be discussed. The Panel should carefully consider the data presented in this report, and issue a Tentative Report with a safe, safe with qualifications, insufficient data, or split conclusion. __________________________________________________________________________________________ 1620 L St NW, Suite 1200, 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 _Brown Algae-derived ingredients ______________________________ MEETING ___December 2018___________________________________________________________ Public Comment CIR Expert Panel Report Status Priority List INGREDIENT PRIORITY LIST SLR July 26, 2018 DRAFT REPORT Sept 2018 Draft Report 60 day public comment period Table Table IDA TR IDA Notice IDA DRAFT TENTATIVE REPORT Draft TR Dec 2018 Table Table Tentative Report Issue TR Draft FR DRAFT FINAL REPORT 60 day Public comment period Table Table Different Conclusion Issue PUBLISH Final Report FR Distributed for Comment Only -- Do Not Cite or Quote History of Brown Algae August 2018: SLR announced for public comment September 2018: draft report reviewed by Panel; the Panel issued an IDA; the Panel requested the following data: • Composition and organic constituent data for each of these Brown Algae-derived cosmetic ingredients • 28-Day dermal toxicity data for those ingredients that are not GRAS • Sensitization data at relevant use concentrations for all ingredients (e.g., Macrocystis Pyrifera (Kelp) Extract at 36.4%) • Genotoxicity data for those ingredients that are not GRAS Following the September 2018 meeting, information regarding manufacturing, composition, genotoxicity, sensitization, skin irritation, and ocular irritation regarding several brown algae ingredients were received. December 2018: the Panel reviews the draft tentative report Distributed for Comment Only -- Do Not Cite or Quote Brown Algae Data Profile for December 2018. Writer – Priya Cherian Acute Repeated ADME toxicity dose toxicity Irritation Sensitization Use Log K Penetration Dermal Oral Dermal Inhale Oral Dermal Ocular Ocular In Vitro Dermal DermalHuman Dermal In Vitro Animal Human VitroIn Repro/Devel Genotoxicity Carcinogenicity Phototoxicity Inhale ow Animal Animal 1. Agarum Cribrosum Extract x 2. Alaria Esculenta Extract x x x x 3. Ascophyllum Nodosum x 4. Ascophyllum Nodosum x x x x x x Extract 5. Ascophyllum Nodosum x x Powder 6. Cladosiphon Novae- Caledoniae Extract 7. Cladosiphon Okamuranus x Extract 8. Cystoseira x x x Amentacea/Caespitosa/ Branchycarpa Extract 9. Cystoseira Baccata Extract x x 10. Cystoseira Balearica Extract 11. Cystoseira Caespitosa Extract 12. Cystoseira Compressa x x Extract 13. Cystoseira Compressa Powder 14. Cystoseira Tamariscifolia x Extract 15. Dictyopteris Membranacea Extract (Retired) 16. Dictyopteris Polypodioides x Extract 17. Dictyota Coriacea Extract 18. Durvillea Antarctica Extract x 19. Ecklonia Cava Extract x x x 20. Ecklonia Cava Water x 21. Ecklonia Kurome Extract 22. Ecklonia Kurome Powder 23. Ecklonia/Laminaria Extract 24. Ecklonia Maxima Extract 25. Ecklonia Maxima Powder 26. Ecklonia Radiata Extract x 27. Eisenia Arborea Extract 28. Fucus Serratus Extract x 29. Fucus Spiralis Extract x x 30. Fucus Vesiculosus x 31. Fucus Vesiculosus Extract x x x x x x x 32. Fucus Vesiculosus Powder x 33. Halidrys Siliquosa Extract x x x x 34. Halopteris Scoparia Extract 35. Himanthalia Elongata x x x Extract 36. Himanthalia Elongata x Powder 37. Hizikia Fusiforme Extract x 38. Hizikia Fusiformis Water Distributed for Comment Only -- Do Not Cite or Quote Brown Algae Data Profile for December 2018. Writer – Priya Cherian Acute Repeated ADME toxicity dose toxicity Irritation Sensitization Use Log K Penetration Dermal Oral Dermal Inhale Oral Dermal Ocular Ocular In Vitro Dermal DermalHuman Dermal In Vitro Animal Human VitroIn Repro/Devel Genotoxicity Carcinogenicity Phototoxicity Inhale ow Animal Animal 39. Hizikia Fusiformis Callus Culture Extract 40. Hydrolyzed Ecklonia Cava Extract 41. Hydrolyzed Fucus Vesiculosus Extract 42. Hydrolyzed Fucus Vesiculosus Protein 43. Kappaphycus Alvarezii Extract 44. Laminaria
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