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Opinion on Methyl Salicylate (Methyl 2-Hydroxybenzoate)

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Opinion on Methyl Salicylate (Methyl 2-Hydroxybenzoate) SCCS/1633/21 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Scientific Committee on Consumer Safety 15 16 SCCS 17 18 19 20 21 OPINION 22 on Methyl salicylate 23 24 (methyl 2-hydroxybenzoate) 25 26 27 28 29 30 31 32 33 34 35 36 The SCCS adopted this document 37 at its plenary meeting on 24-25 June 2021 38 SCCS/1633/21 Preliminary version Opinion on methyl salicylate (methyl 2-hydroxybenzoate) 1 2 ACKNOWLEDGMENTS 3 4 Members of the Working Group are acknowledged for their valuable contribution to this Opinion. 5 The members of the Working Group are: 6 7 8 For the preliminary version 9 10 SCCS members 11 Dr U. Bernauer 12 Dr L. Bodin 13 Prof. Q. Chaudhry (SCCS Chair) 14 Prof. P.J. Coenraads (SCCS Vice-Chair and Chairperson of the WG) 15 Prof. M. Dusinska 16 Dr J. Ezendam 17 Dr E. Gaffet 18 Prof. C. L. Galli 19 Dr B. Granum 20 Prof. E. Panteri 21 Prof. V. Rogiers (SCCS Vice-Chair) 22 Dr Ch. Rousselle (Rapporteur) 23 Dr M. Stepnik 24 Prof. T. Vanhaecke 25 Dr S. Wijnhoven 26 27 SCCS external experts 28 Dr A. Koutsodimou 29 Prof. W. Uter 30 Dr N. von Goetz 31 32 33 34 35 36 37 38 39 40 41 42 All Declarations of Working Group members are available on the following webpage: 43 Register of Commission expert groups and other similar entities (europa.eu) 44 45 46 47 SCCS/1633/21 Preliminary version Opinion on methyl salicylate (methyl 2-hydroxybenzoate) 1 2 1. ABSTRACT 3 4 The SCCS concludes the following: 5 6 7 (1) In light of the data provided and taking under consideration the RAC Opinion on Methyl 8 salicylate and the expected new classification as Toxic for Reproduction Category 2 of Methyl 9 salicylate (to be introduced by an update of Annex VI Reg. 1272/2008), does the SCCS 10 consider Methyl salicylate safe when used up to the maximum concentrations provided in the 11 dossier submitted by the applicant? 12 The SCCS considers Methyl salicylate safe when used in cosmetic products up to the 13 maximum concentrations provided in the dossier submitted by the applicant as detailed in 14 Table 1, except for mouth washes used below 10 years old. 15 (2) Does the SCCS have any further scientific concerns with regard to the use of Methyl salicylate 16 in cosmetic products, also in relation to the RAC recommended classification of Methyl 17 salicylate as ‘Skin sensitizer Category 1B’? 18 19 Methyl salicylate should be considered as a weak skin sensitiser in humans and eye irritant. 20 Moreover the SCCS would like also to express other concerns related to the use of methyl 21 salicylate: 22 Methyl salicylate can be used in consumer products other than cosmetic products, 23 such as household cleaning products, air care products, biocides (e.g. disinfectants, 24 pest control products), polishes and waxes which may increase the systemic 25 exposure dose with a possibility to exceed the safe level. 26 Methyl salicylate will be metabolised in the body to salicylic acid which is also 27 classified as a reprotoxicant and used in cosmetic products (see opinion 28 SCCS/1601/18). Therefore the combined exposure to cosmetic products containing 29 various salicylates may increase the systemic exposure dose with a possibility to 30 exceed the safe level. 31 The SCCS also notices that wintergreen oil that is used in cosmetic products may contain up 32 to 99% methyl salicylate. Therefore when calculating the content of methyl salicylate in a 33 cosmetic product, any fraction coming from wintergreen oil should also be considered. 34 35 36 Keywords: SCCS, scientific opinion, methyl salicylate, methyl 2-hydroxybenzoate, Regulation 37 1223/2009 38 39 Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on methyl 40 salicylate (methyl 2-hydroxybenzoate), preliminary version of 24-25 June, SCCS/1633/21 41 42 SCCS/1633/21 Preliminary version Opinion on methyl salicylate (methyl 2-hydroxybenzoate) 1 2 About the Scientific Committees 3 Two independent non-food Scientific Committees provide the Commission with the scientific 4 advice it needs when preparing policy and proposals relating to consumer safety, public health 5 and the environment. The Committees also draw the Commission's attention to the new or 6 emerging problems which may pose an actual or potential threat. 7 These Committees are: the Scientific Committee on Consumer Safety (SCCS) and the Scientific 8 Committee on Health, Environmental and Emerging Risks (SCHEER) and they are made up of 9 scientists appointed in their personal capacity. 10 In addition, the Commission relies upon the work of the European Food Safety Authority (EFSA), 11 the European Medicines Agency (EMA), the European Centre for Disease prevention and Control 12 (ECDC) and the European Chemicals Agency (ECHA). 13 SCCS 14 The Committee shall provide Opinions on questions concerning health and safety risks (notably 15 chemical, biological, mechanical and other physical risks) of non-food consumer products (for 16 example cosmetic products and their ingredients, toys, textiles, clothing, personal care and 17 household products such as detergents, etc.) and services (for example: tattooing, artificial sun 18 tanning, etc.). 19 20 Scientific Committee members 21 Ulrike Bernauer, Laurent Bodin, Qasim Chaudhry, Pieter Jan Coenraads, Maria Dusinska, Janine 22 Ezendam, Eric Gaffet, Corrado Lodovico Galli, Berit Granum, Eirini Panteri, Vera Rogiers, 23 Christophe Rousselle, Maciej Stepnik, Tamara Vanhaecke, Susan Wijnhoven 24 25 26 Contact 27 European Commission 28 Health and Food Safety 29 Directorate C: Public Health 30 Unit C2 – Health information and integration in all policies 31 L-2920 Luxembourg 32 [email protected] 33 34 © European Union, 2021 35 36 ISSN ISBN 37 Doi: ND- 38 39 The Opinions of the Scientific Committees present the views of the independent scientists who 40 are members of the committees. They do not necessarily reflect the views of the European 41 Commission. The Opinions are published by the European Commission in their original language 42 only. 43 44 http://ec.europa.eu/health/scientific_committees/consumer_safety/index_en.htm 45 46 47 48 SCCS/1633/21 Preliminary version Opinion on methyl salicylate (methyl 2-hydroxybenzoate) 1 2 TABLE OF CONTENTS 3 4 ACKNOWLEDGMENTS ............................................................................................. 2 5 1. ABSTRACT .................................................................................................... 3 6 2. MANDATE FROM THE EUROPEAN COMMISSION ................................................. 6 7 3. OPINION ...................................................................................................... 8 8 3.1 CHEMICAL AND PHYSICAL SPECIFICATIONS ............................................. 8 9 3.1.1 Chemical identity ................................................................................. 8 10 3.1.2 Physical form ...................................................................................... 9 11 3.1.3 Molecular weight ................................................................................. 9 12 3.1.4 Purity, composition and substance codes ................................................ 9 13 3.1.5 Impurities / accompanying contaminants.............................................. 10 14 3.1.6 Solubility .......................................................................................... 10 15 3.1.7 Partition coefficient (Log Pow) .............................................................. 10 16 3.1.8 Additional physical and chemical specifications ...................................... 10 17 3.1.9 Homogeneity and Stability .................................................................. 10 18 3.2 EXPOSURE ASSESSMENT & TOXICOKINETICS ........................................ 11 19 3.2.1 Function and uses .............................................................................. 11 20 3.2.2 Dermal / percutaneous absorption ....................................................... 12 21 3.2.3 Other studies on toxicokinetics ............................................................ 14 22 3.2.4 Calculation of SED/LED ...................................................................... 16 23 3.3 TOXICOLOGICAL EVALUATION .............................................................. 29 24 3.3.1. Irritation and corrosivity .................................................................... 31 25 3.3.2 Skin sensitisation .............................................................................. 35 26 3.3.3 Acute toxicity .................................................................................... 35 27 3.3.4 Repeated dose toxicity ....................................................................... 38 28 3.3.5 Reproductive toxicity ......................................................................... 42 29 3.3.6 Endocrine disrupting effects ................................................................ 51 30 3.3.6 Mutagenicity / genotoxicity ................................................................. 52 31 3.3.7 Carcinogenicity.................................................................................. 56 32 3.3.8 Photo-induced toxicity ........................................................................ 56 33 3.3.9 Human data ...................................................................................... 56 34 3.3.10 Special investigations ....................................................................... 56 35 3.4 SAFETY EVALUATION (including calculation of the MoS) ........................... 57 36 3.5 DISCUSSION .....................................................................................
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