Hydroxyethoxyphenyl Butanone’ (HEPB)
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SCCS/1582/16 Final version Scientific Committee on Consumer Safety SCCS OPINION ON Ethylzingerone – ‘Hydroxyethoxyphenyl Butanone’ (HEPB) (Cosmetics Europe No P98) The SCCS adopted this Opinion by written procedure on 7 April 2017 SCCS/1582/16 Final Opinion on Ethylzingerone - ‘Hydroxyethoxyphenyl Butanone’ (HEPB) - Cosmetics Europe No P98 About the Scientific Committees Three independent non-food Scientific Committees provide the Commission with the scientific advice it needs when preparing policy and proposals relating to consumer safety, public health and the environment. The Committees also draw the Commission's attention to the new or emerging problems which may pose an actual or potential threat. They are: the Scientific Committee on Consumer Safety (SCCS), the Scientific Committee on Health and Environmental Risks (SCHER) and the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and are made up of external experts. In addition, the Commission relies upon the work of the European Food Safety Authority (EFSA), the European Medicines Agency (EMA), the European Centre for Disease prevention and Control (ECDC) and the European Chemicals Agency (ECHA). SCCS The Committee shall provide Opinions on questions concerning all types of health and safety risks (notably chemical, biological, mechanical and other physical risks) of non-food consumer products (for example: cosmetic products and their ingredients, toys, textiles, clothing, personal care and household products such as detergents, etc.) and services (for example: tattooing, artificial sun tanning, etc.). Scientific Committee members Ulrike Bernauer, Laurent Bodin, Leonardo Celleno, Qasim Chaudhry, Pieter Jan Coenraads, Maria Dusinska, Janine Ezendam, Eric Gaffet, Corrado Lodovico Galli, Berit Granum, Eirini Panteri, Vera Rogiers, Christophe Rousselle, Maciej Stepnik, Tamara Vanhaecke, Susan Wijnhoven. Contact European Commission Health and Food Safety Directorate C: Public Health, Country Knowledge and Crisis Management Unit C2 – Country Knowledge and Scientific Committees Office: HTC 03/073 L-2920 Luxembourg [email protected] © European Union, 2017 ISSN 1831-4767 ISBN 978-92-79-81014-5 Doi:10.2875/59572 EW-AQ-18-003-EN-N The Opinions of the Scientific Committees present the views of the independent scientists who are members of the committees. They do not necessarily reflect the views of the European Commission. The Opinions are published by the European Commission in their original language only. http://ec.europa.eu/health/scientific_committees/consumer_safety/index_en.htm 2 SCCS/1582/16 Final Opinion on Ethylzingerone - ‘Hydroxyethoxyphenyl Butanone’ (HEPB) - Cosmetics Europe No P98 ACKNOWLEDGMENTS SCCS members listed below are acknowledged for their valuable contribution to the finalisation of this Opinion. SCCS Members Dr U. Bernauer (Rapporteur) Dr L. Bodin Prof. Q. Chaudhry Prof. P.J. Coenraads (Chairperson) Prof. M. Dusinska Dr J. Ezendam Prof. C. L. Galli Dr B. Granum Prof. E. Panteri Prof. V. Rogiers Dr Ch. Rousselle Dr M. Stepnik Prof. T. Vanhaecke Dr S. Wijnhoven The additional contribution for the drafting of the preliminary Opinion of former members of the SCCS (2013-2016) listed below is gratefully acknowledged. Former SCCS Member Dr. J. van Benthem Prof. G. H. Degen Prof. J. Duus-Johansen This Opinion has been subject to a commenting period of a minimum eight weeks after its initial publication (from 12 January until 10 March 2017). Comments received during this time were considered by the SCCS. For this Opinion, comments received resulted in the following changes: section 3.3.5.2. oral toxicity, and the further scientific concerns (point 3 of the conclusions) including on eye irritation. Keywords: SCCS, scientific opinion, Ethylzingerone - ‘Hydroxyethoxyphenyl Butanone’ (HEPB) - Cosmetics Europe No P98, Regulation 1223/2009, CAS 569646-79-3 Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Ethylzingerone - ‘Hydroxyethoxyphenyl Butanone’ (HEPB) - Cosmetics Europe No P98, SCCS/1582/16, 7 April 2017 3 SCCS/1582/16 Final Opinion on Ethylzingerone - ‘Hydroxyethoxyphenyl Butanone’ (HEPB) - Cosmetics Europe No P98 TABLE OF CONTENTS ACKNOWLEDGMENTS ........................................................................................... 3 1. BACKGROUND ............................................................................................. 6 2. TERMS OF REFERENCE .................................................................................. 6 3. OPINION ..................................................................................................... 7 3.1 Chemical and Physical Specifications ....................................................... 7 3.1.1 Chemical identity .................................................................... 7 3.1.2 Physical form ......................................................................... 8 3.1.3 Molecular weight .................................................................... 8 3.1.4 Purity, composition and substance codes .................................... 8 3.1.5 Impurities / accompanying contaminants ................................... 8 3.1.6 Solubility ............................................................................. 10 3.1.7 Partition coefficient (Log Pow) .................................................. 10 3.1.8 Additional physical and chemical specifications .......................... 10 3.1.9 Stability .............................................................................. 11 3.2 Function and uses .............................................................................. 11 3.3 Toxicological Evaluation ...................................................................... 11 3.3.1 Acute toxicity ....................................................................... 11 3.3.2 Irritation and corrosivity ........................................................ 12 3.3.3 Skin sensitisation .................................................................. 15 3.3.4 Toxicokinetics ...................................................................... 15 3.3.5 Repeated dose toxicity .......................................................... 18 3.3.6 Reproductive toxicity ............................................................. 21 3.3.7 Mutagenicity / Genotoxicity .................................................... 22 3.3.8 Carcinogenicity ..................................................................... 26 3.3.9 Photo-induced toxicity ........................................................... 26 3.3.10 Human data ......................................................................... 27 3.3.11 Special investigations ............................................................ 27 3.4 Exposure assessment ......................................................................... 28 3.5 Safety evaluation (including calculation of the MoS) ................................ 28 3.6 Discussion ........................................................................................ 30 4. CONCLUSION ............................................................................................ 33 5. MINORITY OPINION .................................................................................... 33 6. REFERENCES ............................................................................................. 34 4 SCCS/1582/16 Final Opinion on Ethylzingerone - ‘Hydroxyethoxyphenyl Butanone’ (HEPB) - Cosmetics Europe No P98 1. BACKGROUND Ethylzingerone with INCI name ‘Hydroxyethoxyphenyl Butanone’ (HEPB) Cosmetics Europe No P98 - CAS No 569646-79-3 is a cosmetic ingredient not regulated under Cosmetic Regulation No 1223/2009 with the function as skin conditioning agent. In September 2015, the Commission' services received a dossier from industry to support the safe use of Hydroxyethoxyphenyl Butanone (HEPB) when used as preservative in rinse-off, oral care and leave-on cosmetic products. According to the above-mentioned dossier the safety profile of HEPB has been studied in preclinical studies conducted according to Good Laboratory Practices and following OECD guidelines whenever available. They were conducted using HEPB from batches which were well characterized analytically with a minimum purity of 95.9%. 2. TERMS OF REFERENCE (1) In light of the data provided, does the SCCS consider safe the use of Hydroxyethoxyphenyl Butanone (HEPB) as a cosmetic preservative in rinse-off, oral care and leave-on cosmetic products with a maximum concentration of 2.0 % under an aggregate exposure scenario for cosmetics? (2) Alternatively, what is according to the SCCS, the maximum target concentration considered safe for use of Hydroxyethoxyphenyl Butanone (HEPB) as a cosmetic preservative in rinse-off, oral care and leave-on cosmetic products under an aggregate exposure scenario for cosmetics? (3) Does the SCCS have any further scientific concerns regarding the use of Hydroxyethoxyphenyl Butanone (HEPB) in cosmetic products? 5 SCCS/1582/16 Final Opinion on Ethylzingerone - ‘Hydroxyethoxyphenyl Butanone’ (HEPB) - Cosmetics Europe No P98 3. OPINION 3.1 Chemical and Physical Specifications 3.1.1 Chemical identity 3.1.1.1 Primary name and/or INCI name Hydroxyethoxyphenyl butanone (INCI) 3.1.1.2 Chemical names 4-(3-ethoxy-4-hydroxyphenyl)butan-2-one 3.1.1.3 Trade names and abbreviations Ethylzingerone R0069279A HEPB SCCS comment For convenience, the abbreviation HEPB will be used throughout the Opinion. 3.1.1.4 CAS