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Eucalyptus Globulus (Eucalyptus)-Derived Ingredients As Used in Cosmetics

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Eucalyptus Globulus (Eucalyptus)-Derived Ingredients As Used in Cosmetics Safety Assessment of Eucalyptus globulus (Eucalyptus)-Derived Ingredients as Used in Cosmetics Status: Draft Final Report for Panel Review Release Date: May 11, 2018 Panel Meeting Date: June 4 - 5, 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, 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1200 ♢ Washington, DC 20036-4702 ♢ ph 202.331.0651 ♢ fax 202.331.0088 [email protected] Distributed For Comment Only -- Do Not Cite or Quote Commitment & Credibility since 1976 MEMORANDUM To: CIR Expert Panel and Liaisons From: Lillian C. Becker, M.S. Scientific Analyst and Writer Date: May 11, 2018 Subject: Safety Assessment of Eucalyptus globulus (Eucalyptus)-Derived Ingredients As Used In Cosmetics Attached is the Draft Final Report of Eucalyptus globulus (Eucalyptus)-derived ingredients as used in cosmetics. [eucaly062018rep] The source for all of these ingredients is the leaf of the plant; one ingredient is obtained from the twigs as well. In March 2018, the Panel issued a Tentative Report with the conclusion that these 6 ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment when formulated to be non-sensitizing. No new data have been discovered or submitted since the Tentative Report was announced. The data that were submitted in Wave 2 and Wave 3 prior to the March 2018 meeting have been incorporated into the report and highlighted in yellow. This includes data on Eucalyptus Globulus Leaf Extract (characterization, method of manufacture, and chemical/physical properties), Eucalyptus Globulus Leaf Oil (animal and human dermal irritation, human ocular irritation, and human sensitization), and eucalyptol (acute dermal toxicity and dermal irritation in rabbits). ADME data on eucalyptol from the rosemary report were also added. Also included in this Panel book are the flow chart [eucaly062018flow] history of this report [eucaly062018hist], the data profile [eucaly062018prof], the search strategy [eucaly062018strat], transcripts [eucaly062018min], FDA’s VCRP data [eucaly062018FDA], and Council comments [eucaly062018pcpc_1,2]. The Panel should carefully review the Abstract, Discussion, and Conclusion of this report. If these are satisfactory, the Panel should issue a Final Report. __________________________________________________________________________________________ 1620 L Street, 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 __ Eucalyptus globulus (Eucalyptus) -derived ingredients _________________ MEETING ___June 2018________________________________________________________________ Public Comment CIR Expert Panel Report Status Priority List INGREDIENT PRIORITY LIST SLR Oct 5, 2017 DRAFT REPORT Dec 2017 Draft Report 60 day public comment period Table Table IDA TR IDA Notice IDA Dec 8, 2017 DRAFT TENTATIVE REPORT Mar 2018 Draft TR Table Table Tentative Report Issue TR Mar 16, 2018 Draft FR DRAFT FINAL REPORT June 2018 60 day Public comment period Table Table Different Conclusion Issue PUBLISH Final Report FR Distributed For Comment Only -- Do Not Cite or Quote HISTORY – Eucalyptus globulus-Derived Ingredients 2016 – Eucalyptus globulus added to the priority list. October, 2017 – SLR posted with the following data request: The CIR is seeking, at a minimum, the following information on Eucalyptus globulus-derived cosmetic ingredients for use in the resulting safety assessment: 1. dermal irritation and sensitization data on Eucalyptus globulus-derived ingredients, for which such data were not available; 2. because these ingredients are botanicals and composition and extraction methods vary, specific chemical composition data, as well as the extraction solvent used for each cosmetic product being tested, should be included with all data that are submitted; 3. clarification of the definition of Eucalyptus Globulus Leaf Oil, which states that the oil may be sourced from other Eucalyptus species [Eucalyptus Globulus Leaf Oil is the volatile oil obtained from the leaves of Eucalyptus globulus and other species of Eucalyptus.] December, 2017 – The Panel examined the Draft Report and issued an IDA. The data needs were: • Sensitization on Eucalyptus Globulus Leaf Oil at 5.5% or greater • Impurity data on all ingredients • Margin of safety (MOS) calculations for inhalation and dermal exposure using the Eucalyptus Globulus Leaf Oil and/or the major constituent, eucalyptol (1,8-cineole) The Panel decided not to add Eucalyptol to the report but to add the information that was supplied in the December Memo to the report as supporting information. March, 2018 – Impurity data and an HRIPT at 0.5% Eucalyptus Globulus Leaf Oil were submitted. The other data needs have not been addressed. Does the supporting information on Eucalyptol and the new data meet the Panel’s needs? Wave 2 - The Council updated the concentration of use data. The maximum use concentration of Eucalyptus Globulus Leaf Oil in body and hand preparations (not spray) was corrected from 5.5% to 0.1%. Therefore, the highest maximum concentration for leave-on use (with dermal contact) is now 0.4%. The Panel reviewed the report and come to the conclusion that these Eucalyptus-derived ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment when formulated to be non-sensitizing and issued a Tentative Report. June, 2018 – Wave 2 and 3 data from March were incorporated into the report. The Panel should review the report and review the Abstract, Discussion, and Introduction to ensure that they reflect the Panel’s thinking. The Panel should issue a Final Report. Distributed For Comment Only -- Do Not Cite or Quote Eucalyptus globulus-Derived Ingredients Data Profile for June 2018. Writer – Lillian Becker 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 Eucalyptus Globulus Leaf Oil X X X X X X X X X X X X Eucalyptus Globulus Leaf X Eucalyptus Globulus Leaf Extract X X X Eucalyptus Globulus Leaf Powder X Eucalyptus Globulus Leaf/Twig X Oil Eucalyptus Globulus Leaf Water X Eucalyptol x x x x x x x x x x x x x Distributed For Comment Only -- Do Not Cite or Quote Eucalyptus globulus-Derived Ingredients Ingredient CAS # InfoBase SciFinder PubMed TOXNET FDA EU ECHA IUCLID SIDS HPVIS NICNAS NTIS NTP WHO FAO FEMA Web Eucalyptus Globulus 8000-48-4 Y 12/3 Y Y Y Y Y N N N N N N N N N Y Leaf Oil Eucalyptus Globulus Y 0 Y Y Y Y N N N N N N N Y Y Y Y Leaf Eucalyptus Globulus 84625-32-1 Y 0 Y Y Y Y Y N N N N N N N N N Y Leaf Extract Eucalyptus Globulus Y 0 Y Y N Y N N N N N N N N N N Y Leaf Powder Eucalyptus Globulus Y 0 Y Y Y Y N N N N N N N N N N Y Leaf/Twig Oil Eucalyptus Globulus Y 0 Y Y N Y n N N N N N N N N N Y Leaf Water Botanical and/or Fragrance Websites (if applicable) Ingredient CAS # Dr. Duke’s Taxonomy GRIN Sigma-Aldrich IFRA RIFM Eucalyptus Globulus Leaf Oil 8000-48-4 Y N N N N N Eucalyptus Globulus Leaf Y N N N N N Eucalyptus Globulus Leaf 84625-32-1 N N N N N N Extract Eucalyptus Globulus Leaf N N N N N N Powder Eucalyptus Globulus Leaf/Twig Y N N N N N Oil Eucalyptus Globulus Leaf N N N N N N Water Distributed For Comment Only -- Do Not Cite or Quote Search Strategy PUBMED "Eucalyptus Globulus" OR "8000-48-4" OR "84625-32-1" 555 hits. Culled “AND tox*” – 48 (3 possibly useful); AND “geno*” – 0; AND repro* - 4 not useful; AND sensit* - 17 not useful; AND Irritat* - 0; AND carc* - 140 – 4 possibly useful. SciFinder "Eucalyptus Globulus", INCI names, and CAS Nos. 13 hits. None useful. Distributed For Comment Only -- Do Not Cite or Quote Transcripts – Eucalyptus globulus-Derived Ingredients March, 2018 Dr. Marks’ Team DR. MARKS: Next is eucalyptus. We have a draft tentative report dated February 9th of this year. In December of last year, the panel issued an insufficient data announcement on Lillian’s memo. The three needs were elucidated sensitization, impurity, and margin of safety calculations, which Ron Hill wanted. I just wanted to confirm, Lillian, that on wave two we now have that the highest concentration is 0.4 percent for the leaf oil? MS. BECKER: Correct. DR. MARKS: Okay. Ron and Tom, do you prefer to comment before you’re influenced by Ron Shank, or do you want me to read Ron Shank’s comments first? DR. SLAGA: Well, we have some data. If we followed suite like we have done on some other botanicals, I could go with being formulated to be non-sensitizing. DR. MARKS: That’s what I have. Safe when formulated to be non-sensitizing. And we have this safety for sensitization now since the highest concentration of leaf oil is 0.4. We, in wave two, got more method of manufacture and impurities data. It looks like Ron Shank agrees with that. The bottom line -- well, he said conclusion -- four possible conclusions.
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