Evaluation of selected sensitizing fragrance substances A LOUS follow-up project Environmental project No. 1840, 2016 Title: Authors: Evaluation of selected sensitizing fragrance Lea Bredsdorff substances Elsa Nielsen Published by: The Danish Environmental Protection Agency Strandgade 29 1401 Copenhagen K Denmark www.mst.dk/english Year: ISBN no. 2016 978-87-93435-46-9 Disclaimer: The Danish Environmental Protection Agency publishes reports and papers about research and development projects within the environmental sector, financed by the Agency. The contents of this publication do not necessarily represent the official views of the Danish Environmental Protection Agency. By publishing this report, the Danish Environmental Protection Agency expresses that the content represents an important contribution to the related discourse on Danish environmental policy. Sources must be acknowledged. 2 Evaluation of selected sensitizing fragrance substances Contents Contents .................................................................................................................... 3 Preface ...................................................................................................................... 6 Summary and conclusion .......................................................................................... 7 Sammenfatning og konklusion ................................................................................ 10 1. Introduction ..................................................................................................... 13 2. Selection of substances ..................................................................................... 15 2.1 Selection of substances from the LOUS survey report ..................................................... 15 2.2 Selection of substances from the SCCS (2012) opinion ................................................... 15 2.3 The substances selected for this project............................................................................ 15 3. Data collection and evaluation .......................................................................... 19 3.1 Data collection ...................................................................................................................19 3.1.1 Human data....................................................................................................................... 20 3.1.2 Animal data ........................................................................................................................ 21 3.1.3 In vitro data ...................................................................................................................... 22 3.1.4 Non-testing data ............................................................................................................... 23 3.2 Evaluation of data ............................................................................................................. 23 3.2.1 Quality of data ................................................................................................................... 23 3.3 Comparison with classification criteria according to the CLP Regulation ..................... 24 3.3.1 Classification criteria for sub-category 1A ....................................................................... 24 4. Results, Phase 1 ................................................................................................ 27 5. Results, Phase 2 ................................................................................................ 30 5.1 Citral ................................................................................................................................... 31 5.1.1 Summary of the available data .......................................................................................... 31 5.1.2 Comparison with criteria ................................................................................................... 31 5.1.3 Conclusions on classification and labelling ..................................................................... 32 5.2 Cinnamaldehyde ............................................................................................................... 33 5.2.1 Summary of the available data ......................................................................................... 33 5.2.2 Comparison with criteria .................................................................................................. 33 5.2.3 Conclusions on classification and labelling ..................................................................... 34 5.3 Cinnamyl alcohol .............................................................................................................. 35 5.3.1 Summary of the available data ......................................................................................... 35 5.3.2 Comparison with criteria .................................................................................................. 35 5.3.3 Conclusions on classification and labelling ..................................................................... 36 Evaluation of selected sensitizing fragrance substances 3 5.4 Coumarin ........................................................................................................................... 37 5.4.1 Summary of the available data ......................................................................................... 37 5.4.2 Comparison with criteria .................................................................................................. 37 5.4.3 Conclusions on classification and labelling ..................................................................... 38 5.5 Eugenol .............................................................................................................................. 39 5.5.1 Summary of the available data ......................................................................................... 39 5.5.2 Comparison with criteria .................................................................................................. 39 5.5.3 Conclusions on classification and labelling ..................................................................... 40 5.6 Farnesol ..............................................................................................................................41 5.6.1 Summary of the available data ..........................................................................................41 5.6.2 Comparison with criteria ...................................................................................................41 5.6.3 Conclusions on classification and labelling ..................................................................... 42 5.7 Geraniol ............................................................................................................................. 43 5.7.1 Summary of the available data ......................................................................................... 43 5.7.2 Comparison with criteria .................................................................................................. 43 5.7.3 Conclusions on classification and labelling ..................................................................... 44 5.8 7-Hydroxycitronellal ......................................................................................................... 45 5.8.1 Summary of the available data ......................................................................................... 45 5.8.2 Comparison with criteria .................................................................................................. 45 5.8.3 Conclusions on classification and labelling ..................................................................... 46 5.9 Methyl oct-2-ynoate .......................................................................................................... 47 5.9.1 Summary of the available data ......................................................................................... 47 5.9.2 Comparison with criteria .................................................................................................. 47 5.9.3 Conclusions on classification and labelling ..................................................................... 48 5.10 Cinnamomum cassia leaf oil / Cinnamomum zeylanicum, ext. .................................... 49 5.10.1 Summary of the available data ....................................................................................... 49 5.10.2 Comparison with criteria ................................................................................................ 49 5.10.3 Conclusions on classification and labelling ................................................................... 49 5.11 Evernia prunastri extract ................................................................................................ 50 5.11.1 Summary of the available data ....................................................................................... 50 5.11.2 Comparison with criteria ................................................................................................ 50 5.11.3 Conclusions on classification and labelling .................................................................... 51 5.12 Conclusion .......................................................................................................................... 51 6. Discussion .......................................................................................................