SCCS/1615/20 Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON hair dye Indigofera tinctoria (C170) CAS 84775-63-3 Submission III The SCCS adopted this document by written procedure on 3 April 2020 SCCS/1615/20 Final Opinion Opinion on hair dye Indigofera tinctoria (C170) - Submission III ___________________________________________________________________________________________ ACKNOWLEDGMENTS Members of the Working Group are acknowledged for their valuable contribution to this Opinion. The members of the Working Group are: SCCS members Dr U. Bernauer Dr L. Bodin Prof. Q. Chaudhry (SCCS Chair) Prof. P.J. Coenraads (SCCS Vice-Chair and Chairperson of the WG) Prof. M. Dusinska Dr J. Ezendam Dr E. Gaffet Prof. C. L. Galli Dr B. Granum (Rapporteur) Prof. E. Panteri Prof. V. Rogiers (SCCS Vice-Chair) Dr Ch. Rousselle Dr M. Stepnik Prof. T. Vanhaecke Dr S. Wijnhoven SCCS external experts Dr A. Koutsodimou Dr A. Simonnard Prof. W. Uter All Declarations of Working Group members are available on the following webpage: https://ec.europa.eu/transparency/regexpert/index.cfm This Opinion has been subject to a commenting period of a minimum eight weeks after its initial publication (from 13 January until 13 March 2020). Comments received during this time period are considered by the SCCS. For this Opinion, no comment was received. Therefore, the final version is unchanged except for a minor correction in SCCS comment on submission III, page 13 (section 3.1.5). 2 SCCS/1615/20 Final Opinion Opinion on hair dye Indigofera tinctoria (C170) - Submission III ___________________________________________________________________________________________ 1. ABSTRACT The SCCS concludes the following: (1) In light of the data provided, does the SCCS consider Indigofera tinctoria (C170) safe when used in non-oxidative conditions hair colouring products at on-head concentrations of up to 25%? In light of the data provided, the SCCS considers that Indigofera tinctoria is safe when used in non-oxidative condition hair colouring products at on-head concentrations of up to 25%. (2) Does the SCCS have any further scientific concerns with regard to the use of Indigofera tinctoria (C170) in cosmetic products? A weak skin sensitisation potential cannot be excluded for Indigofera tinctoria. Keywords: SCCS, scientific opinion, Indigofera tinctoria, C170, hair dye, Regulation 1223/2009, CAS 84775-63-3, EC 283-892-6 Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on hair dye Indigofera tinctoria (C170), Submission III, preliminary version of 10 January 2020, final version of 3 April 2020, SCCS/1615/20 3 SCCS/1615/20 Final Opinion Opinion on hair dye Indigofera tinctoria (C170) - Submission III ___________________________________________________________________________________________ About the Scientific Committees Two 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) and the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) and are made up of scientists appointed in their personal capacity. 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, 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, Crisis Management Unit C2 – Country Knowledge and Scientific Committees L-2920 Luxembourg [email protected] © European Union, 2020 ISSN ISBN Doi: ND- 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 4 SCCS/1615/20 Final Opinion Opinion on hair dye Indigofera tinctoria (C170) - Submission III ___________________________________________________________________________________________ TABLE OF CONTENTS 1. ABSTRACT .................................................................................................. 3 2. MANDATE FROM THE EUROPEAN COMMISSION ................................................ 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 ............................................. 10 3.1.6 Solubility ........................................................................................ 14 3.1.7 Partition coefficient (Log Pow) ............................................................. 16 3.1.8 Additional physical and chemical specifications ..................................... 16 3.1.9 Homogeneity and Stability ................................................................. 16 3.2 FUNCTION AND USES ......................................................................... 18 3.3 TOXICOLOGICAL EVALUATION ............................................................. 18 3.3.1 Acute toxicity ....................................................................... 18 3.3.2 Irritation and corrosivity ........................................................ 19 3.3.3 Skin sensitisation .................................................................. 22 3.3.4 Toxicokinetics ...................................................................... 24 3.3.5 Repeated dose toxicity .......................................................... 24 3.3.6 Reproductive toxicity ............................................................. 25 3.3.7 Mutagenicity / genotoxicity .................................................... 27 3.3.8 Carcinogenicity ..................................................................... 32 3.3.9 Photo-induced toxicity ........................................................... 32 3.3.10 Human data ......................................................................... 33 3.3.11 Special investigations ............................................................ 33 3.3.12 Safety evaluation (including calculation of the MOS) .................. 33 3.3.13 Discussion ........................................................................... 33 4. CONCLUSION ............................................................................................ 35 5. MINORITY OPINION .................................................................................... 35 6. REFERENCES ............................................................................................. 36 7. GLOSSARY TERMS ...................................................................................... 37 8. LIST OF ABBREVIATIONS ............................................................................ 37 5 SCCS/1615/20 Final Opinion Opinion on hair dye Indigofera tinctoria (C170) - Submission III ___________________________________________________________________________________________ 2. MANDATE FROM THE EUROPEAN COMMISSION Background Submission I for Indigofera tinctoria (C170) (CAS 84775-63-3) was submitted in October 2003. On the 23 April 2004, the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) adopted, by written procedure, an opinion (SCCNFP/0790/04) according to which..."a complete safety dossier on Indigofera tinctoria is required". Following the Submission II (2006) the SCCS adopted an opinion (SCCS/1439/11) at its 16th plenary meeting of 18 September 2012 on Indigofera tinctoria (C170) with the following conclusion: The SCCS is of the opinion that the safety of Indigofera tinctoria used as a hair dye at a maximum concentration on the head of 25% cannot be assessed due to incomplete information. The safety of Indigo (CI 73 000) used as a colorant should be re-assessed. Submission III on the hair dye Indigofera tinctoria (C170) was transmitted by Cosmetics Europe in November