BLUE Decyl Glucosides CIR EXPERT PANEL MEETING DECEMBER 12-13, 2011 Memorandum To: CIR Expert Panel Members and Liaisons From: Monice M. Fiume MMF Senior Scientific Analyst/Writer Date: November 21, 2011 Subject: Draft Final Safety Assessment on Decyl Glucosides and Other Alkyl Glucosides as Used in Cosmetics Included is the draft Final Safety Assessment on Decyl Glucosides and other Alkyl Glucosides as Used in Cosmetics. Nineteen ingredients are being reviewed. At the September meeting, the Panel issued a tentative safety assessment with a conclusion of safe in the present practices of use and concentration when formulated to be non-irritating. No additional data have been received. Comments on the tentative safety assessment on decyl glucoside and other alkyl glucosides as used in cosmetics were received from the Council, and these comments have been addressed. The Panel should be prepared to issue a final conclusion at this meeting. Distributed for Comment Only -- Do Not Cite or Quote CIR Panel Book Page 1 Distributed for Comment Only -- Do Not Cite or Quote History - Decyl Glucosides and Other Alkyl Glucosides February 24, 2011: Scientific Literature Review The following unpublished data were included in the SLR: 1. Unpublished information on glucoside ingredients. Memo dated Dec 14, 2010. a. Cognis Care Chemicals. 2010. Data profile PLANTACARE 810 UP (Caprylyl/Capryl Glucoside); b. Cognis Care Chemicals. 2010. Data profile PLANTACARE 818 UP (Coco-Glucoside); c. Cognis Care Chemicals. 2010. Data profile PLANTACARE 1200 UP (Lauryl Glucoside); d. Cognis Care Chemicals. 2010. Data profile PLANTACARE 2000 JP (Decyl Glucoside); e. Consumer Product Testing Company. 1993. Repeat insult patch test of 5% active lauryl glucoside and decyl glucoside; f. Consumer Product Testing Company. 2005. Repeat insult patch test of coco- glucoside (1% active). 2. Concentration of use by FDA product category: glucoside ingredients. Memo dated Jan 7, 2011. 3. Updated concentration of use by FDA product category: Glucoside ingredients. Memo dated Jan 28, 2011 June 27-28, 2011: Draft Safety Assessment The following were received after the SLR was announced. The data have been incorporated into the report, and the comments have been addressed. 1. Comments on the Scientific Literature Review on Decyl Glucosides and Other Alkyl Glucosides as Used in Cosmetics. Memo dated March 23, 2011. 2. Concentration of use by FDA product category: Hexyldecyl d-Glucoside and Octadecyl d-Glucoside. Memo dated March 15, 2011. 3. In Vitro dermal penetration study: Caprylyl/Capryl Glucoside. Memo dated April 8, 2011 The Expert Panel noted the absence of dermal sensitization data at an active ingredient concentration of 11% and issued an insufficient data announcement requesting human dermal sensitization data (HRIPT) for decyl glucoside at 11% active ingredient, the maximum reported leave-on use concentration reported. If it is determined that the 11% reported use concentration of decyl glucoside is actually use at 11% with only <100% decyl glucoside, then appropriate modifications may be made to the testing protocol. Those submitting data should note that the percent active ingredient should be identified in all data submissions. The Expert Panel requested clarification as to whether the reported use concentrations of decyl glucoside, as well as the other alkyl glucosides, relate to the active ingredient. September 26-27, 2011: Draft Tentative Safety Assessment A clarification as to whether the reported use concentration is reported as active ingredient was received – and the reporting is as active ingredient. The leave-on use at 11% active ingredient decyl glucoside was reported incorrectly.; the greatest leave-on use concentration is 5% lauryl glucoside. The following unpublished data were received and included in the safety assessment: - Updated concentration of use by FDA product category: Glucoside Ingredients. Memo dated Aug. 16, 2011. - AMA Laboratories, Inc. 2002. 100 Human subject repeat insult patch test skin irritation/sensitization evaluation (occlusive patch) of an indoor tanning preparation containing 0.5% Decyl Glucoside. AMA Ref No.: MSO2.R1PTC38440. 100.DERM.TRLI. - Product Investigations, Inc. 2005. Determination of the irritating and sensitizing propensities of a liquid foundation (containing 1.8%) Decyl Glucoside on human skin. The Panel issued a Tentative Report with the conclusion of safe in the present practices of use when formulated to be non- irritating. December 11-12, 2011: Draft Final Safety Assessment CIR Panel Book Page 2 Distributed for Comment Only -- Do Not Cite or Quote Decyl Glucoside and Other Alkyl Glucosides Data Profile* – Dec 2011 – Writer, Monice Fiume Rptd Dose, Inhalaiton Repro/Dev Tox Genotox Carcinogeni- city Dermal Irr/Sens Ocular Irritation Use Reported Method of Manufacture Toxicokinetic Data Tox – Animal Acute, Derrmal Tox – Animal Acute, Oral Animal Tox, Acute, Inhalation Tox – Animal Rptd Dose, Dermal Animal Tox, Rptd Dose, Oral Tox – Animal Decyl Glucoside X X X Arachidyl Glucoside X Butyl Glucoside C10-16 Alkyl Glucoside X X C12-18 Alkyl Glucoside C12-20 Alkyl Glucoside X C20-22 Alkyl Glucoside Caprylyl/Capryl Glucoside X X X X X X X X Caprylyl Glucoside X X X Cetearyl Glucoside X Coco-Glucoside X X X Ethyl Glucoside X X X Hexadecyl D‐Glucoside X Isostearyl Glucoside Lauryl Glucoside X X X X Myristyl Glucoside X Octadecyl D‐Glucoside X Octyldodecyl Glucoside Undecyl Glucoside Alkyl Polyglucosides (APGs), General Info X X X X Previously Reviewed Fatty Alcohols Yr. Rev. n-Butyl Alcohol 2008 X X X X X X X X Cetearyl Alcohol 1988 X X Cetyl Alcohol 1988 X X X X X X X X Coconut Alcohol 2008 Isostearyl Alcohol 1988 X X X Myristyl Alcohol 1988 X X X X Octyl Dodecancol 1985 X X X X Stearyl Alcohol 1985 X X X X X X X *“X” indicates that data were available in a category for the ingredient 1 CIR Panel Book Page 3 Distributed for Comment Only -- Do Not Cite or Quote Decyl Glucoside Search Strategy constant search update every week using Keep Me Posted tool in SciFinder Searched term Triton 100 using SciFinder – July 11, 2011 89 hits ordered 7 papers SciFinder Search – April 7, 2011 History Session began April 7, 2011 at 12:35 PM April 7, 2011 12:36 PM Explore substances by ID: glucoside initiated Explore complete Explore results No answers April 7, 2011 12:48 PM Explore substances by ID: 34625-23-5, 27214-60-4, 65309-84-4, 58846-77-8, 124828-32-6, 148406-76-2, 150679-30-4, 6801-88-3, 6801-92-9, 265312-14-9, 6801-86-1, 41444-56-8 initiated Explore complete Explore results Answer set 2 created with 6 answers from REGISTRY April 7, 2011 12:57 PM Explore substances by ID: 30285-48-4, 5391-18-4, 41444-57-9, 29836-26-8, 58846-77-8, 68515-73-1, 141464-42-8, 98283-67-1, 27836-64-2, 110615-47-9, 54549-26-7, 144982-05-8, 68515-73-1, 110615-47-9, 200413-69-0, 34625-23-5, 27214-60-4, 65309-84-4, 58846-77-8, 124828-32-6, 148406-76-2, 150679-30-4 initiated Explore complete Explore results Answer set 3 created with 13 answers from REGISTRY Saved 13 substance answers from Answer set 3 as 'Decyl glucoside 1' Retrieve reference information in 13 substances of Answer set 3 Answer set 4 created with 3,080 answers from CAPLUS 336 answers from MEDLINE Refine Answer set 4 by document type Book, Clinical Trial, Conference, Journal, Letter, Report, Review Answer set 5 created with 1,814 answers from CAPLUS 335 answers from MEDLINE Detailed display from Answer set 5 of Expanding Coverage of the Metabolome for Global Metabolite Profiling Saved 2149 reference answers from Answer set 5 as 'Decyl Gluc 1 Refines by pub type' CIR Panel Book Page 4 Distributed for Comment Only -- Do Not Cite or Quote Refine Answer set 4 by document type Patents only Answer set 6 created with 1,268 answers from CAPLUS April 7, 2011 1:03 PM Explore substances by ID: 6801-88-3, 6801-92-9, 265312-14-9, 6801-86-1, 41444-56-8, C12-18 Alkyl Glucoside, C12-20 Alkyl Glucoside, C12-20 Alkyl Glucoside, C20-22 Alkyl Glucoside, Cetearyl Glucoside, Coco- Glucoside, Octyldodecyl Glycoside initiated Explore complete Explore results Answer set 7 created with 5 answers from REGISTRY Saved 5 substance answers from Answer set 7 as 'decyl gluc 2' Combine the current substance answer set with saved answer sets initiated: decyl gluc 2 OR Decyl glucoside 1 at April 7, 2011 1:04 PM Answer set 8 created with 15 answers from REGISTRY Saved 15 substance answers from Answer set 8 as 'Decyl glucoside All' Retrieve reference information in 15 substances of Answer set 8 Answer set 9 created with 3,080 answers from CAPLUS 336 answers from MEDLINE Saved 3416 reference answers from Answer set 9 as 'Decyl Glucoside All' Refine Answer set 9 by document type Book, Clinical Trial, Conference, Journal, Preprint, Report, Review Answer set 10 created with 1,815 answers from CAPLUS 333 answers from MEDLINE Saved 2148 reference answers from Answer set 10 as 'Decyl Glucoside refined by document type' Refine Answer set 10 by research topic sugar surfactant Answer set 11 created with 49 answers from CAPLUS Detailed display from Answer set 11 of Physical properties and inhibitory effects of three-component hybrid liposomes including sugar surfactants Detailed display from Answer set 11 of Alkylpolyglycoside: carbohydrate based surfactant Detailed display from Answer set 11 of Adsorption of n-Decyl-β-D-glucopyranoside and n-Decyl-β-D-maltopyranoside Mixtures at the Liquid-Vapor Interface Explore results Answer set 14 created with 16 answers from CAPLUS 131 answers from MEDLINE Detailed display from Answer set 14 of Irritant and sensitizing potential of eight surfactants commonly used in skin cleansers: an evaluation of 105 patients Full text accessed for Irritant and sensitizing potential of eight surfactants commonly used in skin cleansers: an evaluation of 105 patients from Dermatitis : contact, atopic, occupational, drug : official journal of the American Contact Dermatitis Society, North American Contact Dermatitis Group Volume: 21 Issue: 5 Pages: 262-8 2010 April 7, 2011 1:22 PM Explore references by research topic: decyl glucoside initiated, resulting in 2 candidates Explore complete Candidates Selected 413 references were found containing "decyl glucoside" as entered.