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GREEN Decyl Glucoside and Other Alkyl Glucosides CIR EXPERT

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GREEN Decyl Glucoside and Other Alkyl Glucosides CIR EXPERT GREEN Decyl Glucoside and Other Alkyl Glucosides CIR EXPERT PANEL MEETING JUNE 27-28, 2011 Administrative Memorandum To: CIR Expert Panel Members and Liaisons From: Monice M. Fiume MMF Senior Scientific Analyst/Writer Date: June 3, 2011 Subject: Decyl Glucosides and Other Alkyl Glucosides as Used in Cosmetics – Draft Report Included is the draft report on the Decyl Glucosides and other Alkyl Glucosides as Used in Cosmetics. This is the first time the Panel is seeing this document. The Scientific Literature Review was issued on February 24, 2011. Glucoside hydrolases present in human skin may break down these chemicals to their respective starting materials, i.e., glucose and a fatty alcohol. Therefore, summary information from reports on fatty alcohols that have previously been reviewed by the CIR is presented in Table 6. Copies of these reports are available online at http://www.cir-safety.org/jun11.shtml . The following are included in the data tab: 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 Unpublished information on glucoside ingredients.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. 4. Concentration of use by FDA product category: Hexyldecyl d-Glucoside and Octadecyl d-Glucoside. Memo dated March 15, 2011. 5. In Vitro dermal penetration study: Caprylyl/Capryl Glucoside. Memo dated April 8, 2011 6. Comments on the Scientific Literature Review on Decyl Glucosides and Other Alkyl Glucosides as Used in Cosmetics. Memo dated March 23, 2011. 7. FDA raw data. Items 1, 2, and 3 from the above list were included in the SLR. If there are no additional data needs, the Panel should be prepared to formulate a tentative con- clusion with rationale and issue a Tentative Report for public comment. If the data are not com- plete for making a determination of safety, then an Insufficient Data Announcement should be issued listing the additional data that are needed. 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 Scientific Literature Review: February 24, 2011 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 Draft Report: June 27-28, 2011 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 CIR Panel Book Page 2 Distributed for Comment Only -- Do Not Cite or Quote 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' 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' CIR Panel Book Page 3 Distributed for Comment Only -- Do Not Cite or Quote 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--D-glucopyranoside and n-Decyl--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. Automatically removed 6 duplicate MEDLINE answer(s) Explore results Answer set 15 created with 399 answers from CAPLUS 8 answers from MEDLINE April 7, 2011 1:23 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. CIR Panel Book Page 4 Distributed for Comment Only -- Do Not Cite or Quote Automatically removed 8 duplicate MEDLINE answer(s) 929 references were found containing the concept "decyl glucoside". Automatically removed 8 duplicate MEDLINE answer(s) Explore results Answer set 18 created with 915 answers from CAPLUS 6 answers from MEDLINE Explore references by research topic: glucoside initiated, resulting in 2 candidates April 7, 2011 1:26 PM Explore references by research topic: glucoside initiated, resulting in 2 candidates Limiters Book, Preprint, Clinical Trial, Report, Journal, Review, Conference April 7, 2011 1:27 PM Explore references by research topic: 30285-48-4 initiated, resulting in 2 candidates Limiters Book, Preprint, Clinical Trial, Report, Journal, Review, Conference Explore complete Candidates
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