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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 Report for Panel Review Release Date: August 29, 2018 Panel Meeting Date: September 24-25, 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1200 ♢ Washington, DC 20036-4702 ♢ ph 202.331.0651 ♢ fax 202.331.0088 [email protected] Distributed for Comment Only -- Do Not Cite or Quote Commitment & Credibility since 1976 Memorandum To: CIR Expert Panel Members and Liaisons From: Priya Cherian, Scientific Analyst/Writer Date: August 29, 2018 Subject: Safety Assessment of Brown Algae as Used in Cosmetics Enclosed is the Draft Report of 83 brown algae-derived ingredients as used in cosmetics. (It is identified as broalg092018rep in this pdf.) This is the first time the Panel is reviewing this document. The ingredients in this review are extracts, powders, juices, or waters derived from one or multiple species of brown algae. Information received from the Personal Care Products Council (Council) are attached: • use concentration data of brown algae and algae-derived ingredients (broalg092018data1, broalg092018data2, broalg092018data3); • Information regarding hydrolyzed fucoidan extracted from Laminaria digitata has been included in the report. Although fucoidan is a not one of the ingredients being reviewed in the report, data regarding fucoidan has been included in the report as it is a primary constituent in many brown algae species (broalg092018data4). • information regarding a trade name mixture containing Ascophyllum Nodosum Extract (broalg092018data5); • ocular irritation and sensitization data of products containing Sargassum Muticum Extract (broalg092018data6); • sensitization data of a night cream containing Alaria Esculenta Extract (broalg092018data7). Additionally, Council comments on the SLR were received (broalg092018pcpc), and have been addressed. The presentation made for the Panel on Algal diversity and application, given by Rex L. Lowe, is available at the (June 2014) meeting page, https://www.cir-safety.org/sites/default/files/broalg092018data8.pdf. The following are also included in this package for your review: • broalg092018flow: report flowchart • broalg092018hist: history • broalg092018prof: data profile • broalg092018strat: search strategy • broalg092018FDA: 2018 VCRP data After reviewing these documents, if the available data are deemed sufficient to make a determination of safety the Panel should identify matters to be addressed in the Discussion, and then issue a Tentative Report with a safe as used, safe with qualifications, or unsafe conclusion. If the available data are insufficient, the Panel should issue an Insufficient Data Announcement (IDA), specifying the data needs therein. __________________________________________________________________________________________ 1620 L Street, NW, Suite 1200 ♢ Washington, DC 20036-4702 (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 ___Sept 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 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 Distributed for Comment Only -- Do Not Cite or Quote Brown Algae Data Profile for September 2018. Writer – Priya Cherian Acute Repeated ADME toxicity dose toxicity Irritation Sensitization Use Log K Penetration Dermal Oral Dermal Inhale Oral Dermal Ocular Carcinogenicity Phototoxicity Ocular In Vitro Dermal DermalHuman Dermal In Vitro Animal Human VitroIn Repro/Devel Genotoxicity Inhale ow Animal Animal 1. Agarum Cribrosum Extract x 2. Alaria Esculenta Extract x 3. Ascophyllum Nodosum x 4. Ascophyllum Nodosum x x x x Extract 5. Ascophyllum Nodosum x x Powder 6. Cladosiphon Novae- Caledoniae Extract 7. Cladosiphon Okamuranus x Extract 8. Cystoseira Amentacea/Caespitosa/ Branchycarpa Extract 9. Cystoseira Baccata Extract 10. Cystoseira Balearica Extract 11. Cystoseira Caespitosa Extract 12. Cystoseira Compressa x x Extract 13. Cystoseira Compressa Powder 14. Cystoseira Tamariscifolia 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 30. Fucus Vesiculosus x 31. Fucus Vesiculosus Extract x x x x 32. Fucus Vesiculosus Powder x 33. Halidrys Siliquosa Extract 34. Halopteris Scoparia Extract 35. Himanthalia Elongata x Extract 36. Himanthalia Elongata Powder 37. Hizikia Fusiforme Extract x 38. Hizikia Fusiformis Water 39. Hizikia Fusiformis Callus Culture Extract 40. Hydrolyzed Ecklonia Cava Extract Distributed for Comment Only -- Do Not Cite or Quote Brown Algae Data Profile for September 2018. Writer – Priya Cherian Acute Repeated ADME toxicity dose toxicity Irritation Sensitization Use Log K Penetration Dermal Oral Dermal Inhale Oral Dermal Ocular Carcinogenicity Phototoxicity Ocular In Vitro Dermal DermalHuman Dermal In Vitro Animal Human VitroIn Repro/Devel Genotoxicity Inhale ow Animal Animal 41. Hydrolyzed Fucus Vesiculosus Extract 42. Hydrolyzed Fucus Vesiculosus Protein 43. Kappaphycus Alvarezii Extract 44. Laminaria Angustata Extract (Retired) 45. Laminaria Cloustoni Extract x 46. Laminaria Diabolica Extract 47. Laminaria Digitata Extract x 48. Laminaria Digitata Powder x 49. Laminaria Hyperborea x Extract 50. Laminaria Japonica Extract x x x 51. Laminaria Japonica Powder x 52. Laminaria Longissima Extract 53. Laminaria Ochotensis Extract (Retired) 54. Laminaria Ochroleuca x Extract 55. Laminaria Saccharina Extract 56. Lessonia Nigrescens x Extract 57. Lessonia Nigrescens Powder 58. Macrocystis Pyrifera (Kelp) x 59. Macrocystis Pyrifera (Kelp) Blade/Pneumatocyst/Stipe Juice Extract 60. Macrocystis Pyrifera (Kelp) x Extract 61. Macrocystis Pyrifera (Kelp) Juice 62. Macrocystis Pyrifera (Kelp) x Protein 63. Nereocystis Luetkeana Extract 64. Pelvetia Canaliculata x Extract 65. Pelvetia Siliquosa Extract 66. Phyllacantha Fibrosa Extract 67. Saccharina Angustata x Extract 68. Saccharina Japonica Extract 69. Saccharina Longicruris Extract 70. Sargassum Filipendula x Extract 71. Sargassum Fulvellum x Extract 72. Sargassum Fusiforme Extract Distributed for Comment Only -- Do Not Cite or Quote Brown Algae Data Profile for September 2018. Writer – Priya Cherian Acute Repeated ADME toxicity dose toxicity Irritation Sensitization Use Log K Penetration Dermal Oral Dermal Inhale Oral Dermal Ocular Carcinogenicity Phototoxicity Ocular In Vitro Dermal DermalHuman Dermal In Vitro Animal Human VitroIn Repro/Devel Genotoxicity Inhale ow Animal Animal 73. Sargassum Glaucescens Extract 74. Sargassum Horneri Extract 75. Sargassum Muticum x Extract 76. Sargassum Pallidum x Extract 77. Sargassum Siliquastrum Extract 78. Sargassum Thunbergii Extract 79. Sargassum Vulgare Extract x 80. Sphacelaria Scoparia x Extract 81. Undaria Peterseniana Extract 82. Undaria Pinnatifida Extract x x 83. Undaria Pinnatifida Cell Culture Extract 84. Undaria Pinnatifida x Leaf/Stem Extract 85. Undaria Pinnatifida Powder x x x 86. Undaria Pinnatifida Root Powder Distributed for Comment Only -- Do Not Cite or Quote Brown Algae Ingredient CAS # InfoBase SciFinder PubMed TOXNET FDA EU ECHA IUCLID SIDS HPVIS NICNAS NTIS NTP WHO FAO FEMA Web 1. Agarum Cribrosum - - X X X X X X N N N n n √ Extract 2. Alaria Esculenta - - X X X X X X √ Extract 3. Ascophyllum - - √ X √ X X X √ Nodosum 4. Ascophyllum 84775-78-0 √ √ X √ X X C √ Nodosum Extract 5. Ascophyllum - - √ X X X X X √ Nodosum Powder 6. Asterionellopsis - - X X X X X X X Glacialis Extract 7. Cladosiphon Novae- - - X X X X X X X Caledoniae Extract 8. Cladosiphon - - X X X X X X Okamuranus Extract 9. Cystoseira - - X X X X X X Amentacea/ Caespitosa/ Branchycarpa Extract 10. Cystoseira Baccata - - X X X X X X Extract 11. Cystoseira Balearica - - X X X X X X Extract 12. Cystoseira - - X X X X X X Caespitosa Extract 13. Cystoseira - - X √ X X X X Compressa Extract 14. Cystoseira - - X X X X X X Compressa Powder 15. Cystoseira - - X X X X X X Tamariscifolia Extract 16. Dictyopteris - - X √ X X X X Membranacea Extract (Retired) 17. Dictyopteris - - X X X X X X Polypodioides Extract 18. Dictyota
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